97 23 EC指令 (中英對照)

97/23/EC PED 歐盟壓力設備指令
DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

歐洲議會與理事會的 97/23/EC 指令
of 29 May 1997
1997 年 5 月 29 日
on the approximation of the laws of the Member States concerning pressure equipment
各會員國有關壓力設備之近似法律
THE EUROPEAN PARLIAMENT AND THE 歐洲議會與歐盟理事會，

COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the 就建立歐洲共同體之條約與其中特別條款 100a，

European Community, and in particular Article 100a
thereof,
Having regard to the proposals from the Commission, 就執行委員會(以下簡稱執委會)之提案，
Having regard to the Opinion of the Economic and 參考經濟與社會委員會之意見，

Social Committee,
Acting in accordance with the procedure laid down in 根據條約之條款 189b 所定之程序來立法，在調解
Article 189b of the Treaty, in the light of the joint text
approved by the Conciliation Committee on 4 委員會於 1997 年 2 月 4 日之聯合文字審查下作出
February 1997, 下列決議，
1. Whereas the internal market is an area without 1. 內部市場是指一個沒有內部邊界的區域，可確

internal frontiers in which the free movement of
goods, persons, services and capital is ensured; 保貨品、人民、服務與資金在其中自由流通；
2. Whereas there are differences in the content and 2. 各會員國就有關人民與必要時含家畜或財產，

scope of the laws, regulations and administrative
provisions in force in the Member States with 其安全與健康的防護，所制定的法律、規則與
regard to the safety and protection of health of 行政規定的內容與範圍各有所不同，在現有共
persons and, where appropriate, domestic animals
or property, where pressure equipment not covered 同體法律中也未見有關壓力設備之立法；各會
by present Community legislation is concerned; 員國對此設備的驗證與檢查程序有所不同，如
whereas the certification and inspection procedures
for such equipment differ from one Member State 此情況將造成共同體內的貿易障礙；
to another; whereas such disparities may well
constitute barriers to trade within the Community;
3. Whereas the harmonization of national legislation 3. 要消除這些自由貿易障礙的唯一方法就是調和

is the only means of removing these barriers to
free trade; whereas this objective cannot be 各國的法律；單靠一個會員國是無法滿意地達
achieved satisfactorily by the individual Member 到此一目標；本指令僅制定使設備能自由流通
States; whereas this Directive only lays down
indispensable requirements for the free circulation 不可或缺的要求；
of the equipment to which it is applicable;
4. Whereas equipment subject to a pressure of not 4. 承壓不超過 0.5 bar 的設備將不會因其中之壓力

more than 0.5 bar does not pose a significant
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金屬工業研究發展中心區域研發服務處
hazard due to pressure; whereas there should not 造成實質之危險；對這樣的設備沒有必要限制

therefore be any obstacle to its free movement
within the Community; whereas this Directive 其在會員國內自由流通；本指令適用之設備是
applies to equipment subject to a maximum 承受的最高容許壓力(PS)超過 0.5 bar；
allowable pressure PS exceeding 0.5 bar;
5. Whereas this Directive relates also to assemblies 5. 本指令同時適用於由幾個不同壓力設備所組成

composed of several pieces of pressure equipment
assembled to constitute an integrated and 而成一體且具功能的組合設備(Assemblies)；
functional whole; whereas these assemblies may 從簡單的組合設備如壓力鍋，到複雜的組合設
range from simple assemblies such as pressure
cookers to complex assemblies such as water tube 備如水管式鍋爐都屬之；若組合設備的製造廠
boilers; whereas, if the manufacturer of an 欲將其放進市場且以組合設備型式來服務 ----
assembly intends it to be placed on the market and
put into service as an assembly – and not in the －而不是以零散的型式 ----－此組合設備應符
form of its constituent non-assembled elements – 合本指令；另一方面，本指令並不含在現場組
that assembly must conform to this Directive;
whereas, on the other hand, this Directive does not 裝壓力設備；
cover the assembly of pressure equipment on the
site and under the responsibility of the user, as in
the case of industrial installations;
6. Whereas this Directive harmonizes national 6. 本指令調和各國有關因壓力造成危險的國家規

provisions on hazards due to pressure; whereas the
other hazards which this equipment may present 定；此種設備可能出現的其它危險，或許屬於
accordingly may fall within the scope of other 其它處理這種危險之指令的範圍；然而，壓力
Directives dealing with such hazards; whereas,
however, pressure equipment may be included 設備有可能為其它指令(基於條約條款 100a)所
among products covered by other Directives based 涵蓋之產品；這些指令有一些規定來管制因壓
on Article 100a of the Treaty; whereas the
provisions laid down in some of those Directives 力所產生之危險；這些規定是經審慎考慮，提
deal with the hazard due to pressure; whereas 供適當的保護，以使設備因壓力產生之危險降
those provisions are considered adequate to
provide appropriate protection where the hazard 至最低；
due to pressure associated with such equipment
remains small; whereas, therefore, there are
grounds for excluding such equipment from the
scope of this Directive;
7. Whereas, for pressure equipment covered by 7. 國際慣例、運輸用與有壓力危險之虞所涵蓋的

international Conventions, transport and pressure
hazards are due to be dealt with as soon as 壓力設備，應儘可能以即將公告的共同體指令
possible by forthcoming Community Directives 來管理，這些共同體指令是基於慣列或現有補
based on such Conventions or by supplements to
existing Directives; whereas such equipment is 充說明所制定；這些設備不在本指令適用範圍
accordingly excluded from the scope of this 之內；
Directive;
8. Whereas certain types of pressure equipment, 8. 某些型式的壓力設備，雖然承受最高容許壓力

although subject to a maximum allowable pressure
PS higher than 0.5 bar, do not present any (PS)大於 0.5 bar ，但卻不會因此承壓產生實質
significant hazard due to pressure, and therefore 災害，對於這種設備，如果為合法製造或放置
the freedom of movement of such equipment in
the Community should not be hindered if it has 在會員國市場內，則不應阻礙其自由流通；為
been legally manufactured or placed on the market 確保其能自由流通而將其列入本指令範圍是沒
in a Member State; whereas it is not necessary in
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order to ensure free movement of such equipment 有必要；結果是它可以刻意地被排除於本指令

to include it in the scope of this Directive; whereas
consequently it is expressly excluded from its 之範圍；
scope;
9. Whereas other pressure equipment subject to a 9. 對其它承受最高容許壓力大於 0.5 bar 且會因

maximum allowable pressure higher than 0.5 bar
and presenting a significant hazard due to 此壓力產生實質災害的壓力設備，若能保證有
pressure, but in respect of which free movement 適當安全性，則可被排除在本指令之適用範
and an appropriate level of safety are guarateed, is
excluded from the scope of this Directives; 圍；然而，像這樣的排除應經正式審查以確認
whereas such exclusions from the scope of this 歐盟是否需要採取行動；
Directives; whereas such exclusions should,
however, be regularly reviewed in order to
ascertain whether it is necessary to take action at
Union level;
10. Whereas regulations to remove technical barriers 10. 為消除貿易技術障礙所訂之規則

to trade must follow the new approach provided
for in the Council Resolution of 7 May 1985 on a (Regulations)，需遵循 1985 年 5 月 7 日理事會
new approach to technical harmonization and 決議案—“技術調和與標準的新方法”，訂定
standards, which requires a definition of the
essential requirements regarding safety and other 與安全有關之基本要求，且不可低於各會員國
requirements of society without reducing existing, 內現存且證實有效之其它要求；為避免經常有
justified levels of protection within the Member
States; whereas that Resolution provides that a 修正案與衍生許多指令，決議案提出以一個單
very large number of products be covered by a 一的指令來涵蓋多項產品；
single Directive in order to avoid frequent
amendments and the proliferation of Directives;
11. Whereas the existing Community Directives on 11. 現今與壓力設備有關之會員國近似法律的共同

the approximation of the laws of the Member
States relating to pressure equipment have made 體指令，對消除區域內的貿易障礙已提供正確
positive steps towards removing barriers to trade 方向；但這些指令所涵蓋的範圍太小；1987
in this area; whereas those Directives cover that
sector only to a minor extent; whereas Council 年 6 月 25 日有關簡單壓力容器之理事會
Directive 87/404/EEC of 25 June 1987 on the 87/404/EEC 指令，是第一個調和會員國有關
harmonization of the laws of the Member States
relating to simple pressure vessels is the first case 壓力設備法律新方法的應用；本指令將不適用
of application of the new approach to the sector of 於 87/404/EEC 所涵蓋的範圍；但本指令強制
pressure equipment; whereas the present Directive
will not apply to the area covered by Directive 實施後三年內，應檢討是否需要將 87/404/
87/404/EEC; whereas, no later than three years EEC 指令整合到本指令；
after the present Directive enters into force, a
review will be carried out of the application of
Directive 87/404/EEC in order to ascertain the
need for the integration thereof into the present
Directive;
12. Whereas the framework Directive, Council 12. 1976 年 7 月 27 日理事會 76/767/EEC 指令，是
Directive 76/767/EEC of 27 July 1976 on the
approximation of the laws of the Member States 一針對各會員國有關壓力設備與檢查方法之共
relating to common provisions for pressure vessels 同規定的近以法律，此指令為選擇性的；它提
and methods for inspecting them is optional;
whereas it provides for a procedure for the 供壓力設備試驗與驗證的雙邊承認程序，其運
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bilateral recognition of testing and certification of 作上並不令人滿意，因此將被有效的共同體措

pressure equipment which did not operate
satisfactorily and which therefore must be 施所取代；
replaced by effective Community measures;
13. Whereas the scope of this Directive must be 13. 本指令適用範圍為基於「壓力設備」的一般性

based on a general definition of the term “presure
equipment” so as to allow for the technical 定義，以容許產品之技術開發；
development of products;
14. Whereas compliance with the essential safety 14. 為確保壓力設備的安全，符合基本安全要求

requirements is necessary in order to ensure the
safety of pressure equipment; whereas those (Essential Safety Requirement)是必要的；這些
requirements have been subdivided into general 要求分成一般(General)要求與特定(Specific)要
and specific requirements which must be met by
pressure equipment; whereas in particular the 求；特殊型式的壓力設備需考量是否符合特定
specific requirements are intended to take account 要求；第 III 類與第 IV 類內某些型式的壓力設
of particular types of pressure equipment; whereas
certain types of pressure equipment in categories 備必須執行最終評估(包含最終檢驗與耐壓試
III and IV must be subject to a final assessment 驗)；
comprising final inspection and proof tests;
15. Whereas Member States should be in a position 15. 站在貿易平等的立場，各會員國對尚不符合本

to allow the showing at trade fairs of pressure
equipment which is not yet in conformity with the 指令要求的壓力設備仍應允許展示；在展覽期
requirements of this Directive; whereas, during 間，應根據各會員國為確保人員安全所制定的
demonstrations, appropriate safety measures must
be taken in accordance with the general safety 一般安全法則，採取適當的安全措施。
rules of the Member State concerned to ensure the
safety of persons;
16. Whereas in order to ease the task of 16. 為使遵循基本要求的任務簡單化，調和歐洲各

demonstrating compliance with the essential
requirements, standards harmonized at European 標準是有用的，特別是對於壓力設備的設計、
level are useful, especially with regard to the 製造與試驗，遵循此調和標準的產品，即可推
design, manufacture and testing of pressure
equipment, compliance with which enables a 定其符合基本要求；歐洲標準的調和是由民間
product to be presumed to meet the said essential 團體(Private bodies)草擬，且需維持為非強制
requirements; whereas standards harmonized at
European level are drawn up by private bodies and 狀態；為達到此目標，歐洲標準化委員會
must retain their non-mandatory status; whereas, (CEN)與歐洲電工標準化委員會(CENELEC)被
for this purpose, the European Committee for
Standardization (CEN) and the European 核可為有資格調和標準的組織，這些標準遵從
Committee for Electrotechnical Standardization 執委會與這兩個組織合作在 1984 年 11 月 13
(Cenelec) are recognized as being the bodies that
日所簽定的概要性指導；
are competent to adopt harmonized standards that
follow the general guidelines for cooperation
between the Commission and those two bodies
signed on 13 November 1984;
17. Whereas, for the purposes of this Directive, a 17. 為達到本指令目的，調和標準是在執委會的要

harmonized standard is a technical specification
(European standard or harmonization document) 求下，由這些組織所制定的技術規格(歐洲標
adopted by one or other of those bodies, or by 準或調和文件)，而制定之程序除根據前一項
both, at the request of the Commission pursuant to
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Council Directive 83/189/EEC of 28 March 1983 所提之概要性指導，還需遵照 1983 年 3 月 28

laying down a procedure for the provision of
information in the field of technical standards and 日之理事會 83/189/EEC 指令，此指令對技術
regulations and in accordance with the general 標準與規則此一領域的資訊有所規定；關於標
guidelines referred to above; whereas, in relation
to standardization, it would be advisable for the 準化，由依照 83/189/EEC 所設立的委員會來
Commission to be assisted by the Committee set 協助執委會是合理必要的；有需要的話，執委
up pursuant to Directive 83/189/EEC; whereas the
Committee will, if necessary, consult technical 會可咨詢技術專家。
experts;
18. Whereas manufacturing of pressure equipment 18. 製造壓力設備需使用安全可靠的材料；對一再

calls for the utilization of safe materials; whereas
in the absence of harmonized standards it is useful 使用而調和標準未記載之材料，界定材料特性
to define the characteristics of the materials 是有用的；在「歐洲核准材料」裏有材料特性
intended for repeated use; whereas this definition
is established by European approvals for 的定義；特別指定其中一個驗證機構(Notified
materials, such approvals being issued by one of Bodies)來發行核准之材料；符合「歐洲核准材
the notified bodies specifically designated for that
task; whereas the materials conforming to the 料」裏所定之材料，即可推定其符合本指令基
European approvals shall be presumed to satisfy 本要求；
the essential requirements of this Directive;
19. Whereas, in view of the nature of the hazards 19. 使用壓力設備會有危險，從危險性這個觀點來

involved in the use of pressure equipment it is
necessary to establish procedures for assessing 看，建立一評鑑是否符合本指令基本要求的程
compliance with the basic requirements of the 序是有必要的；這些程序需隨壓力設備的危險
Directives; whereas these procedures must be
devised in the light of the level of danger which is 程度而有所區分；因此，每一種(Category)壓
inherent in the pressure equipment; whereas, 力設備必須選擇一適當的程序或從同等的程序
therefore, for each category of pressure equipment
there must be an adequate procedure or a choice 中作一選擇；採用之程序為 1993 年 7 月 22 日
between different procedures of equivalent 理事會 93/465/EEC 決定(Decision)內的要求，
stringency; whereas the procedures adopted are as
required by Council Decision 93/465/EEC of 22 此決定是有關符合性評鑑程序之模式
July 1993 concerning the modules for the various (Modules)以及 CE 符合標誌的黏貼與使用規
phases of the conformity assessment procedures
則，在調和技術的指令中皆可見到這兩個主
and the rules for the affixing and use of the CE
conformity marking, which are intended to be 題；加入這些程序裏的細節，由壓力設備所需
used in the technical harmonization Directives,
之驗證性質來訂定；
whereas the details added to these procedures are
justified by the nature of the verification required
for pressure equipment;
20.Whereas Member States should be in a position to 20. 各會員國應授權使用者檢查小組來實施某些本

authorize user inspectorates to carry out certain
tasks for conformity assessment in the framework 指令架構下的符合性評鑑任務；為達到此目
of this Directive; whereas for that purpose this 標，本指令訂定會員國授權使用者檢查小組之
Directive sets out criteria for the authorization of
user inspectorates by Member States; 準則；
21. Whereas, under the conditions laid down by this 21. 在本指令所定之條件下，某些符合性評鑑程序
Directive, certain procedures for conformity
assessment may require each item to be inspected 可能需要驗證機構或使用者檢查小組逐項檢查
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and tested by a notified body or a user inspectorate 與測試，此為壓力設備最終評估的一部分；在

as part of the final assessment of the pressure
equipment; whereas in other cases provision 其它情況，需制定某些規定，以確保驗證機構
should be made to ensure that the final assessment 可藉不預期查訪來監督最終評估；
may be monitored by a notified body by means of
unexpected visits;
22. Whereas pressure equipment will, as a general 22. 一般來說，壓力設備的 CE 標誌是由製造廠或

rule, bear the CE marking affixed either by the
manufacturer or by his authorized representative 設在共同體內的授權代表來黏貼；CE 標誌是
established within the Community; whereas the 指此壓力設備符合本指令或其它適用之共同體
CE marking means that the pressure equipment
complies with the provisions of this Directive and 指令的規定；對本指令內所定義的壓力設備，
those of other applicable Community directives on 其僅有很小的壓力危險，且驗證程序無法作有
CE marking; whereas for pressure equipment
defined in this Directive which presents only a 效判定，則該設備不黏貼 CE 標誌；
minor pressure hazard and for which certification
procedures are therefore not justified, the CE
marking will not be affixed;
23. Whereas it is appropriate that the Member States, 23. 根據條約 100a 條款要求，各會員國對人員與
as provided for by Article 100a of the Treaty, may
take provisional measures to limit or prohibit the 必要時含家畜與財產，其安全有特殊風險的壓
placing on the market, putting into service and use 力設備，可採取適當之措施以限制或禁止其放
of pressure equipment in cases where it presents a
particular risk to the safety of persons and, where 在市場、服務與使用，所採取之措施需遵照共
appropriate, domestic animals or property, 同體管制程序；
provided that the measures are subject to a
Community control procedure;
24.Whereas the addresses of any decision taken under 24. 依本指令所採用之任何決定的受文者，必須被

this Directive must be aware of the reasons behind
that decision and the means of appeal open to 告知決定背後所持之理由與公開之申訴方法。
them;
25. Whereas it is necessary to lay down a transitional 25. 為使強制依照國家規則所製造的壓力設備，在

arrangement enabling pressure equipment
manufactured in compliance with the national 本指令的強制實施日時可被允許進入市場與服
regulations in force on the date of entry into force 務，訂定過渡性安排是有其必要的。
of this Directive to be marketed and put into
service;
26. Whereas the requirements laid down in the 26. 在附件內所定之要求，應儘可能清楚制定，讓

Annexes should be made as clear as possible so as
to allow all users, including small and medium- 包括中小企業(SMEs)的使用者能很容易地遵
sized enterprises (SMEs), to comply with them 循這些要求；
easily;
27. Whereas an agreement on a modus vivendi 27. 依據條約條款 189b 所定之程序，歐洲議會、理

between the European Parliament, the Council and
the Commission concerning the implementing 事會與執委會三者之間，所立法制定之有關實
measures for acts adopted in accordance with the 施措施的暫時協議，是在 1994 年 12 月 20 日
procedure laid down in Article 189b of the Treaty
was reached on 20 December 1994. 達成。
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Article 1 條款 1
Scope and definitions 適用範圍與定義
1. This Directive applies to the design, manufacture 1. 本指令應用於最高容許壓力 PS 大於 0.5 bar 的

and conformity assessment of pressure equipment
and assemblies with a maximum allowable 壓力設備與組合設備之設計、製造與符合性評
pressure PS greater than 0.5 bar. 鑑。
2. For the purposes of this Directive: 2. 針對本指令的目的：
2.1 “Pressure equipment” means vessels, piping, 2.1「壓力設備」是指容器、管路、安全附屬設備與

safety accessories and pressure accessories.
壓力附屬設備。
Where applicable, pressure equipment includes 若適用的話，壓力設備包括連接到承壓件之

elements attached to pressurized parts, such as
flanges, nozzles, couplings, supports, lifting lugs, 元件，如凸緣、管嘴、連軸器、支撐物、吊耳等。
etc.
2.1.1 “Vessel” means a housing designed and built to 2.1.1 「容器」是指經設計與建造的一個內含壓力

contain fluids under pressure including its
direct attachments up to the coupling point 流體的殼體，包括連接其它設備之接合點以
connecting it to other equipment. A vessel may 前的直接附屬設備。容器可能是由好幾個壓
be composed of more than one chamber.
力室所組成。
2.1.2 “Piping” means piping components intended 2.1.2 「管路」(Piping)是指用來輸送流體的管路元

for the transport of fluids, when connected
together for integration into a pressure system. 件，當連接在一起時，構成一整體的壓力系
Piping includes in particular a pipe or system 統。管路包括一條特別的輸送管或管系、傳
of pipes, tubing, fittings, expansion joints,
hoses, or other pressure-bearing components as 熱管、配件、伸縮接頭、軟管或其它適當之承
appropriate. Heat exchangers consisting of 壓元件。用來冷卻或加熱空氣而由管所組成
pipes for the purpose of cooling or heating air
shall be considered as piping. 的熱交換器應將其視為管路。
2.1.3 “Safety accessories” means devices designed 2.1.3 「安全附屬設備」是指當超出設備容許限

to protect pressure equipment against the
allowable limits being exceeded. Such devices 時，設計用來保護壓力設備的裝置。這些裝
include; 置包括：
－ devices for direct pressure limitation, such as －直接壓力限裝置，像是安全閥、破裂盤、

safety valves, bursting disc safety devices,
buckling rods, controlled safety pressure 挫屈桿、受控的安全壓力釋放系統
relief systems (CSPRS), and (CSPRS)，與
－ limiting devices, which either activate the －限制裝置，可以是啟動修正方法、停機、

means for correction or provide for
shutdown or shutdown and lockout, such as 停機且鎖死，例如壓力開關、溫度開關、
pressure switches or temperature switches or 液位開關以及「有關安全之量測控制與調
fluid level switches and “safety related
measurement control and regulation 節(SRMCR)」裝置。
(SRMCR)” devices.
7/101
2.1.4 “Pressure accessories” means devices with an 2.1.4 「壓力附屬設備」是指一具操作功能且有承

operational function and having pressure-
bearing housings. 壓殼體的裝置。
2.1.5 “Assemblies” means several pieces of pressure 2.1.5 「組合設備」是指由製造廠組裝多件壓力設

equipment assembled by a manufacturer to
constitute an integrated and functional whole. 備構成一體且具功能之整體。
2.2 “Pressure” means pressure relative to 2.2 「壓力」是指相對於大氣壓之壓力，即錶壓

atmospheric pressure, i.e. gauge pressure. As a
consequence, vacuum is designated by a negative 力。所以，在真空情況下，壓力為負值。
value.
2.3 “Maximum allowable pressure PS” means the 2.3 「最高容許壓力 PS」是指所設計之設備所容
maximum pressure for which the equipment is
designed, as specified by the manufacturer. 許的最高壓力，由製造廠指定。
It is defined at a location specified by the 依製造廠指定之位置來訂定。此點需為保護與/

manufacturer. This must be the location of
connection of protective and/or limiting devices 或限制裝置的連接位置、設備頂點，或當以上
or the top of equipment or if not appropriate any 皆不適用時指定之任意點。
point specified.
2.4 “Maximum/minimum allowable temperature TS” 2.4 「最高/最低容許溫度 TS」是指所設計之壓力設

means the maximum/minimum temperatures for
which the equipment is designed, as specified by 備所容許的最高/最低溫度，由製造廠指定。
the manufacturer.
2.5 “Volume (V)” means the internal volume of a 2.5 「容積(V)」是指壓力室的內容積，包括第 1 段

chamber, including the volume of nozzles to the
first connection or weld and excluding the 連接或銲接到管嘴的容積，不包括內部永久
volume of permanent internal parts. 組件的體積。
2.6 “Nominal size (DN)” means a numerical 2.6 「公稱尺寸(DN)」是指共通於所有管系元件(不

designation of size which is common to all
components in a piping system other than 包括用外徑或螺紋徑標示的元件)的尺寸指定
components indicated by outside diameters or by 值。它是一方便使用而沒有小數點之整數，而
thread size. It is a convenient round number for
reference purposes and is only loosely related to 僅與製造尺寸有些微差異。公稱尺寸用 DN 接
manufacturing dimensions. The nominal size is 著一數字來表示。
designated by DN followed by a number.
2.7 “Fluids” means gases, liquids and vapours in 2.7 「流體」是指氣體、液體與飽和汽。流體可包含

pure phase as well as mixtures thereof. A fluid
may contain a suspension of solids. 固體懸浮物。
2.8 “Permanent joints” means joints which cannot be 2.8 「永久性接頭」是指無法被分開(除非使用破壞

disconnected except by destructive methods.
性方法)的接頭。
2.9 “European approval for materials” means a 2.9 「歐洲核准材料」是指一份定義材料特性的技

technical document defining the characteristics of
materials intended for repeated use in the 術文件，這裏的材料是指壓力設備製造廠經
manufacture of pressure equipment which are not 常使用而調和標準卻未登錄之材料。
8/101
covered by any harmonized standard.
3 The following are excluded from the scope of this 3 下列各項不適用本指令：

Directive:
3.1 pipelines comprising piping or a system of piping 3.1 由管路或管系所組成之管線(Pipelines)，此管

designed for the conveyance of any fluid or
substance to or from an installation (onshore or 線是設計用來輸送任何流體或物質到某一安
offshore) starting from and including the last 置地點(內陸或岸邊)，或從某一安置地點開始
isolation device located within the confines of the
installation, including all the annexed equipment 輸送，從(包括)最後一個位在安置地點邊界內
designed specifically for pipelines. This 的隔離設備開始，包括所有設計給管線用的
exclusion does not apply to standard pressure
equipment such as may be found in pressure 附屬設備。此項排除不適用到標準的壓力設
reduction stations or compression stations; 備，像是在減壓站或加壓站的壓力設備；
3.2 networks for the supply, distribution and 3.2 水的供應網、配送網、排放網以及相關的設

discharge of water and associated equipment and
headraces such as penstocks, pressure tunnels, 備，水力發電廠的水渠、壓力渠道、壓力軸等
pressure shafts for hydroelectric installations and 相關之特定附屬設備；
their related specific accessories;
3.3 equipment covered by Directive 87/404/EEC on 3.3 87/404/EEC 簡單壓力容器指令所涵蓋的設

simple pressure vessels;
備；
3.4 equipment covered by Council Directive 3.4 1975 年 5 月 20 日理事會 75/324/EEC 指令有關
75/324/EEC of 20 May 1975 on the
approximation of the laws of the Member States 霧化罐(Aerosol Dispensers)之會員國近似法律
relating to aerosol dispensers; 所涵蓋的設備；
3.5 equipment intended for the functioning of 3.5 由下列指令與附件所定義之車用設備：

vehicles defined by the following Directives and
their Annexes:
－ Council Directive 70/156/EEC of 6 February － 1970 年 2 月 6 日理事會 70/156/EEC 指令有

1970 on the approximation of the laws of the
Member States relating to the type-approval 關機動車輛與其拖車之型式核准的會員國
of motor vehicles and their trailers, 近似法律，
－ Council Directive 74/150/EEC of 4 March － 1974 年 3 月 4 日理事會 74/150/EEC 指令有

Member States relating to the type-approval 關輪轉式農業或林區牽引機(Tractors)之型
of wheeled agricultural or forestry tractors, 式核准的會員國近似法律，
－ Council Directive 92/61/EEC of 30 June 1992 － 1992 年 6 月 30 日理事會 92/61/EEC 指令有

relating to the type-approval of two or three-
wheel motor vehicles; 關兩輪或三輪機動車輛的型式核准；
3.6 equipment classified as no higher than category I 3.6 不高於本指令條款 9 的第 I 類且為下列指令之

under Article 9 of this Directive and covered by
one of the following Directives: 一所涵蓋的設備：
9/101
－ Council Directive 89/392/EEC of 14 June － 1989 年 6 月 14 日理事會 89/392/EEC 指令

Member States relating to machinery, 有關機械的會員國近似法律，
－ European Parliament and Council Directive － 1995 年 6 月 29 日理事會 95/16/EC 指令有

95/16/EC of 29 June 1995 on the
approximation of the laws of the Member 關升降機的會員國近似法律，
States relating to lifts,
－ Council Directive 73/23/EEC of 19 February － 1973 年 2 月 19 日理事會 73/23/EEC 指令有

1973 on the harmonization of the laws of the
Member States relating to electrical 關設計在某一電壓範圍使用之電機設備的
equipment designed for use within certain 調和法律，
voltage limits,
－ Council Directive 93/42/EEC of 14 June 1993 － 1993 年 6 月 14 日理事會 93/42/EEC 指令有

concerning medical devices,
關醫療器材，
－ Council Directive 90/396/EEC of 29 June － 1990 年 6 月 29 日理事會 90/396/EEC 指令

Member States relating to appliances burning 有關燃燒氣態燃料器具的會員國近似法
gaseous fuels, 律，
－ Directive 94/9/EC of the European Parliament － 1994 年 3 月 23 日歐洲議會與理事

and the Council of 23 March 1994 on the
approximation of the laws of the Member 會 94/9/EC 指令有關在潛在性爆炸環境使
States concerning equipment and protective 用之設備與保護系統的會員國近似法律，
systems intended for use in potentially
explosive atmospheres,
3.7 equipment covered by Article 223 (1) (b) of the 3.7 條約條款 223(1)(b)所涵蓋之設備；
Treaty;
3.8 items specifically designed for nuclear use, 3.8 失效時會導致輻射外洩的核能設備；

failure of which may cause an emission of
radioactivity;
3.9 well-control equipment used in the petroleum, 3.9 使用在石化或地質探勘與萃取工業上，控制

gas or geothermal exploration and extraction
industry and in underground storage which is 性優良之設備且需控制其壓力的地下儲槽。這
intended to contain and/ or control well pressure. 些是由源頭(聖誕樹)，吹洩預防器(blow out
This comprises the wellhead (Christmas tree), the
blow out preventers (BOP), the piping manifolds preventers)，岐管與其上游設備所組成。
and all their equipment upstream;
3.10 equipment comprising casings or machinery 3.10 包含外殼或機械之設備，其尺寸、材料選用

where the dimensioning, choice of material and
manufacturing rules are based primarily on 與製造法則主要是基於有充分強度、剛性與
requirements for sufficient strength, rigidity and 穩定度要求，以符合靜態與動態操作效應或
stability to meet the static and dynamic
operational effects or other operational 其它操作效應，以及當壓力不是一實質的主
characteristics and for which pressure is not a 要設計因素。這些設備可能包括：
significant design factor. Such equipment may
include:
10/101
－ engines including turbines and internal －渦輪引擎與內燃機等引擎，

combustion engines,
－ steam engines, gas/ steam turbines, turbo- －蒸汽引擎，氣體 /蒸汽渦輪機，渦輪發電

generators, compressors, pumps and actuating
devices; 機、壓縮機、泵與致動裝置；
3.11 blast furnaces including the furnace cooling 3.11 鼓風爐包括泠卻系統、熱風復熱器(hot-blast

system, hot-blast recuperators, dust extractors
and blast-furnace exhaust-gas scrubbers and recuperators)，煙塵抽集器(dust extractors)與
direct reducing cupolas, including the furnace 鼓風爐排氣洗氣器(scrubbers)與直接縮減式
cooling, gas converters and pans for melting,
re-melting, de-gassing and casting of steel and 熔鐵爐，包括泠卻、氣體轉化器與鋼、非鐵金
non-ferrous metals; 屬之熔解、再熔解、排氣與鑄造用盤；
3.12 enclosures for high-voltage electrical 3.12 高壓電設備用之封蓋(enclosures)，像是開關

equipment such as switchgear, control gear,
transformers, and rotating machines; 機構(switch gear)、操縱機構(control gear)、變
壓器與旋轉機器；
3.13 pressurized pipes for the containment of 3.13 傳送系統用壓力管路，例如，電力與電話纜

transmission system, e.g. for electrical power
and telephone cables; 線；
3.14 ships, rockets, aircraft and mobile off-shore 3.14 船舶、火箭、航空器與移動式岸邊單元，以及

units, as well as equipment specifically
intended for installation on board or the 特別指定在甲板上安裝之設備或是上述設備
propulsion thereof; 的推進設備；
3.15 pressure equipment consisting of a flexible 3.15 可撓性外殼組成之壓力設備，例如輪胎、空

casing, e.g. tyres, air cushions, balls used for
play, inflatable craft, and other similar pressure 氣避震器、遊戲用的球、充氣船與其它類似的
equipment; 壓力設備；
3.16 exhaust and inlet silencers; 3.16 排氣與進氣消音器；
3.17 bottles or cans for carbonated drinks for final 3.17 最終消費的汽水瓶、罐；
consumption;
3.18 vessels designed for the transport and 3.18 設計用來輸送與供應飲料的容器，其 PS-V
distribution of drinks having a PS-V of not
more than 500 bar-L and a maximum allowable 不超過 500 bar-L 與最高容許壓力不超過 7
pressure not exceeding 7 bar; bar；
3.19 equipment covered by the ADR, the RID, the 3.19 包含 ADR、RID、IMDG 與 ICAO 之設備；
IMDG and the ICAO Convention;
3.20 radiators and pipes in warm water heating 3.20 溫水加熱器用之輻射器與管路；

systems;
3.21 vessels designed to contain liquids with a gas 3.21 設計用來裝液體的容器，此液體的氣化壓力

pressure above the liquid of not more than 0.5
11/101
bar. 不超過 0.5 bar。
Article 2 條款 2
Market surveillance
市場監督
1. Member States shall take all appropriate measures 1. 各會員國應採取適當措施以確保條款 1 所稱之

to ensure that the pressure equipment and the
assemblies referred to in Article 1 may be placed 壓力設備與組合設備經適當安裝、維護與在原
on the market and put into service only if, when 先預定目的下使用，且不會危害到人員與必要
properly installed and maintained and used for
their intended purpose, they do not endanger the 時含家畜或財產的安全與健康，才可以進入市
health and safety of persons and, where 場與服務。
appropriate, domestic animals or property
2. The provisions of this Directive shall not affect 2. 本指令之規定不應影響會員國制定一些要求的

Member States” entitlement to lay down, with due
regard to the provisions of the Treaty, such 權力，此權力是由條約所賦予。為確保人員，
requirements as they may deem necessary to 特別是工人，在操作壓力設備或組合設備期間
ensure that persons and, in particular, workers are
protected during use of the pressure equipment or 有保護措施，這些要求或許是必要的，對於本
assemblies in question provided that this does not 指令未指定的壓力設備或組合設備同樣有此要
mean modifications to such equipment or
assemblies in a way not specified in this Directive. 求。
3. At trade fairs, exhibitions, demonstrations, etc., 3. 在貿易平等原則下，雖然如條款 1 所定義之壓

Member States shall not prevent the showing of
pressure equipment or assemblies as defined in 力設備或組合設備不符合本指令的規定，只要
Article 1 not in conformity with the provisions of 有提供可見之標示清楚指出它們不符合與不可
this Directive, provided that a visible sign clearly
indicates their non-conformity and their non- 銷售，各會員國還是應讓其展示與展覽。展覽
availability for sale until brought into conformity 期間，應根據各會員國主管機關所規定之要
by the manufacturer or by his authorized
representative established within the Community. 求，採取適當的安全措施以確保人員安全。
During demonstrations, appropriate safety
measures shall be taken in accordance with any
requirements laid down by the competent authority
of the Member State concerned in order to ensure
the safety of persons.
Article 3 條款 3
Technical requirements
技術要求
1. The pressure equipment referred to in 1.1, 1.2, 1.3 1. 在 1.1、1.2、1.3 與 1.4 所稱之壓力設備必須滿足
and 1.4 must satisfy the essential requirements set
out in Annex I: 附件 I 所規定之基本要求：
1.1 Vessels, except those referred to in 1.2 for: 1.1 容器(除 1.2 所指定)內裝：
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(a) gases, liquefied gases, gases dissolved under (a) 氣體、液化氣體、加壓下分解氣體、蒸汽與

pressure, vapours and also those liquids
whose vapour pressure at the maximum 在最高容許溫度下之蒸汽壓大於大氣壓
allowable temperature is greater than 0,5 bar 0.5 bar 以上之液體，在下列限制範圍內：
above normal atmospheric pressure, (1 013
mbar) within the following limits:
－ for fluids in Group 1 with a volume －容積大於 1 L 及 PS 與 V 之乘積大於 25
greater than 1 L and a product of PS and
V greater than 25 bar-L, or with a bar-L，或其壓力 PS 大於 200 bar 的第 1
pressure PS greater than 200 bar (Annex 組流體(附件 II，表 1)，
II, table 1),
－ for fluids in Group 2, with a volume －容積大於 1 L 及 PS 與 V 之乘積大於 50

V is greater than 50 bar-L, or with a bar-L，或其壓力 PS 大於 1,000 bar 的
pressure PS greater than 1,000 bar, and 第 2 組流體，與所有攜帶式滅火器與
all portable extinguishers and bottles for
breathing apparatus (Annex II, table 2); 呼吸器用之瓶罐(附件 II，表 2)；
(b) liquids having a vapour pressure at the (b) 在最高容許溫度下之蒸汽壓不超過大氣壓

maximum allowable temperature of not
more than 0,5 bar above normal atmospheric 0.5 bar 以上之液體，在下列限制範圍內：
pressure (1 013 mbar) within the following
limits:
－ for fluids in Group 1 with a volume －容積大於 1L 及 PS 與 V 的乘積大於 200
V greater than 200 bar-L, or with a bar-L，或其壓力 PS 大於 500 bar 的第
pressure PS greater than 500 bar (Annex 1 組流體(附件 II，表 3)，
II, table 3),
－ for fluids in Group 2 with a pressure PS －壓力 PS 大於 10 bar 及 PS 與 V 的乘積
greater than 10 bar and a product of PS
and V greater than 10,000 bar-7L, or with 大於 10,000 bar-L ，或壓力 PS 大於
a pressure PS greater than 1,000 bar 1,000 bar 的第 2 組流體(附件 II，表 4)。
(Annex II, table 4),
1.2 Fired or otherwise heated pressure equipment 1.2 用於產生蒸汽或高於 100℃過熱水，因使用火

with the risk of overheating intended for
generation of steam or super-heated water at 焰或其它熱源而有過熱風險之容積大於 2L 的
temperatures higher than 110℃ having a volume 壓力設備，以及所有的壓力鍋(附件 II，表 5)。
greater than 2L, and all pressure cookers (Annex
II, table 5).
1.3 Piping intended for: 1.3 管路內含：
(a)gases, liquefied gases, gases dissolved under (a) 氣體、液化氣體、加壓下分解氣體、蒸汽與

pressure, vapours and those liquids whose
vapour pressure at the maximum allowable 在最高容許溫度下之蒸汽壓大於大氣壓 0.5
temperature is greater than 0,5 bar above bar 以上之液體，在下列限制範圍內：
normal atmospheric pressure, (1 013 mbar)
within the following limits:
－ for fluids in Group 1 with a DN greater － DN 大於 25 的第 1 組流體(附件 II，表
than 25 (Annex II, table 6),
6)，
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－ for fluids in Group 2 with a DN greater － DN 大於 32 及 PS 與 DN 的乘積大於

than 32 and a product of PS and DN
greater than 1,000 bar (Annex II, table 7); 1,000 bar 的第 2 組流體，(附件 II，表
7)
(b)liquids having a vapour pressure at the (b) 在最高容許溫度下之蒸汽壓不超過大氣
maximum allowable temperature of not more
than 0,5 bar above normal atmospheric 壓 0.5 bar 以上之液體，在下列限制範圍
pressure (1 013 mbar), within the following 內：
limits:
－ for fluids in Group 1 with a DN greater － DN 大於 25 及 PS 與 DN 的乘積大於
than 25 and a product of PS and DN
greater than 2,000 bar (Annex II, table 8), 2,000 bar 的第 1 組流體 ( 附件 II ，表
8)，
－ for fluids in Group 2 with a PS greater －壓力 PS 大於 10 bar ，DN 大於 200 及
than 10 bar, a DN greater than 200 and a
product of PS and DN greater than 5,000 PS 與 DN 的乘積大於 5,000 bar 的第 2
bar (Annex II, table 9). 組流體(附件 II，表 9)。
1.4 Safety and pressure accessories intended for 1.4 在 1.1、1.2 與 1.3 所涵蓋之壓力設備與組合設
equipment covered by 1.1, 1.2 and 1.3 including
where such equipment is incorporated into an 備所使用的安全和壓力附屬設備。
assembly.
2. The assemblies defined in Article 1, section 2.1.5, 2. 條款 1 內 2.1.5 節所定義之組合設備，至少需包

which include at least one item of pressure
equipment covered by section 1 of this Article and 含一該條款第 1 節所涵蓋之壓力設備，本條款
which are listed in 2.1, 2.2 and 2.3 of this Article 內 2.1、2.2 與 2.3 所列之組合設備必須滿足附件
must satisfy the essential requirements set out in
Annex I. I 的基本要求。
2.1 Assemblies intended for generating steam or 2.1 用於產生蒸汽或高於 110℃ 過熱水之組合設
superheated water at a temperature higher than
110℃ comprising at least one item of fired or 備，至少有一項壓力設備有因使用火焰或其
otherwise heated pressure equipment presenting a 它熱源而有過熱的風險。
risk of overheating.
2.2 Assemblies other than those referred to in 2.1, if 2.2 除 2.1 以外之組合設備，若製造廠欲將其放進
the manufacturer intends them to be placed on
the market and put into service as assemblies. 市場且以組合設備之型式服務者。
2.3 By way of derogation from the introductory 2.3 對其它低於本節要求而用以產生不大於 110℃

paragraph to this section, assemblies intended for
generating warm water at temperatures not 溫水的組合設備，此組合設備手動饋入固態
greater than 110℃ which are manually fed with 燃料且 PS-V 大於 50 bar-L ，必須符合附件 I
solid fuels and have a PS-V greater than 50 bar-L
must comply with the essential requirements 內 2.10、2.11、3.4、5(a)與 5(b)之要求。
referred to in 2.10, 2.11, 3.4, 5 (a) and 5 (d) of
Annex I.
3. Pressure equipment and/ or assemblies below or 3. 為確保安全使用，對低於或等於 1.1、1.2 與 1.3

equal to the limits in sections 1.1, 1.2 and 1.3 and
section 2 respectively must be designed and 節與第 2 節之限制的壓力設備及(或)組合設
manufactured in accordance with the sound 備，應根據會員國優秀的工程實務來設計與製
engineering practice of a Member State in order to
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ensure safe use. Pressure equipment and / or 造。壓力設備及(或)組合設備必須有適當使用說

assemblies must be accompanied by adequate
instructions for use and must bear markings to 明書，同時需要有標示以便識別製造廠或建立
permit identification of the manufacturer or of his 在共同體內的授權代表。對這樣的壓力設備及
authorized representative established within the
Community. Such equipment and/ or assemblies (或)組合設備，毋需黏貼條款 15 的 CE 標誌。
must not bear the CE marking referred to in Article
15.
Article 4 條款 4
Free movement 自由流通
1.1. Member States shall not, on grounds of the 1.1. 對於條款 1 所稱之壓力設備或組合設備，符合
hazards due to pressure, prohibit, restrict or
impede the placing on the market or putting into 本指令且貼有 CE 標誌者，表示其已根據條款
service under the conditions specified by the 10 進行符合性評鑑，各會員國不應以有壓力
manufacturer of pressure equipment or
assemblies referred to in Article 1 which comply 會造成危險的理由來禁止、限制或阻礙其進入
with this Directive and bear the CE marking 市場或服務。
indicating that they have undergone conformity
assessment in accordance with Article 10.
1.2. Member States shall not, on grounds of the 1.2. 對於符合條款 3(3)的壓力設備或組合設備，各
hazards due to pressure, prohibit, restrict or
impede the placing on the market or putting into 會員國不應以有壓力會造成危險的理由來禁
service of pressure equipment or assemblies 止、限制或阻礙其進入市場或服務。
which comply with Article 3 (3).
2. Member States may require, to the extent that it is 2. 為壓力設備與組合設備的安全與正確使用，各

needed for safe and correct use of pressure
equipment and assemblies, the information 會員國或許需要以共同體官方語言來提供附件 I
referred to in Annex I sections 3.3 and 3.4 to be 之 3.3 與 3.4 節所述之資訊。當壓力設備或組合
provided in the official language(s) of the
Community which may be determined in 設備送到最終使用者時，根據條約規定，其所
accordance with the Treaty by the Member State in 需資訊是由會員國決定。
which the equipment or assembly reaches the final
user.
Article 5 條款 5
Presumption of conformity 符合之推定
1. Member States shall regard pressure equipment 1. 對貼有條款 15 所規定之 CE 標誌與附件 VII 之
and assemblies bearing the CE marking provided
for in Article 15 and the EC declaration of EC 符合宣告的壓力設備與組合設備，各會員國
conformity provided for in Annex VII as 應將其視為符合本指令之規定，包括條款 10 的
conforming to all the provisions of this Directive,
including the conformity assessment provided for 符合性評鑑。
in Article 10.
2. Pressure equipment and assemblies which conform 2. 對符合國家標準的壓力設備與組合設備，此國
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to the national standards transposing the 家標準是由調和標準轉換過來的，且該調和標

harmonized standards the reference numbers of
which have been published in the Official Journal 準之參照號碼已公告在歐洲共同體的官報上，
of the European Communities shall be presumed to 則此壓力設備與組合設備可推定其符合條款 3
conform to the essential requirements referred to in
Article 3. Member States shall publish the 的基本要求。各會員國應公告引用調和標準之國
reference numbers of the national standards 家標準的參照號碼。
referred to above.
3. Member States shall ensure that appropriate 3. 在準備與監督調和標準的過程中，各會員國應

measures are taken to enable both sides of industry
to have an input at national level in the process of 確保所採取的適當措施能夠使得工業雙方在國
preparing and monitoring the harmonized 家層級有所投入。
standards.
Article 6 條款 6
Committee on technical standards and regulations 技術標準與規則委員會
Where a Member State or the Commission considers 當某一會員國或執委會認為條款 5(2)所稱之標準

that the standards referred to in Article 5(2) do not
entirely meet the essential requirements referred to in 並不全然符合條款 3 的基本要求，有關之會員國
Article 3, the Member State concerned or the 或執委會應將其理由告知常務委員會 (Standing
Commission shall inform the Standing Committee set
up by Article 5 of Directives 83/189/EEC giving the Committee)，此常務委員會是依 83/189/EEC 指令
reasons therefore. The Committee shall issue an 之條款 5 所設立的。此常務委員會應以急件的方式
opinion as a matter of urgency.
發表意見(Opinion)。
Taking into account the Committee”s opinion, the 執委會考量此常務委員會的意見後，應將是否需

Commission shall notify the Member States as to
whether or not those standards should be withdrawn 要從條款 5(2)所稱之出版品中撤消那些標準的決
from the publications referred to in Article 5(2). 定通知各會員國。
Article 7 條款 7
Committee on Pressure Equipment
壓力設備委員會
1. The Commission may take any appropriate 1. 執委會可採取任何適當措施實施下列規定：

measure to implement the following provisions:
Where a Member State considers that, for very 以非常嚴謹的安全理由，某一會員國考慮

serious safety reasons,
－an item or family of pressure equipment －條款 3(3)所稱之一個或同一系列之壓力設

referred to in Article 3 (3) should be subject to
the requirements of Article 3 (1), or 備，應承受條款 3(1)的要求，或
－an assembly or family of assemblies referred to －條款 3(3)所稱之一組或同一系列之組合設

in Article 3 (3) should be subject to the
requirements of Article 3 (2), or 備，應承受條款 3(2)的要求，或
－an item or family of pressure equipment should －低於附件 II 要求的一個或同一系列的壓力設
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be classified, by way of derogation from the 備應將其歸到某一種類，

requirements of Annex II, in another category,
It shall submit a duly substantiated request to the 會員國應交付一正當具體的要求給執委會，

Commission and ask it to take the necessary
measures. Those measures shall be adopted in 且要求其採取適當措施。這些措施應根據第 3
accordance with the procedure laid down in 段所定之程序來採用。
paragraph 3.
2. The Commission shall be assisted by a Standing 2. 常設委員會(以下簡稱委員會)應協助執委會，

Committee, hereafter referred to as “the
Committee”, composed of representatives 此委員會是由各會員國所任命的代表所組成，
appointed by the Member States and chaired by a 而由執委會的代表擔任主席。
representative of the Commission.
The Commission shall draw up its own rules of 委員會可草擬自已的程序法則。

procedure.
3. The representative of the Commission shall submit 3. 執委會代表應將遵照第 1 段所考慮之措施的草

to the Committee a draft of the measures to be
taken pursuant to paragraph 1. The Committee 案交付給委員會。委員會應以急件方式在此草
shall deliver its opinion on the draft, within a time 案上表達其意見，必要時投票表決。
limit which the chairman may lay down according
to the urgency of the matter, if necessary by taking
a vote.
The opinion shall be record in the minutes; in 應立即記錄這些意見；此外，每個會員國有權

addition, each Member State shall have the right to
ask to have its position recorded in the minutes. 要求立即記錄其發表的見解。
The Commission shall take the utmost account of 執委會應對委員會所表達的意見加以考慮。禮

the opinion delivered by the Committee. It shall
inform the Committee of the manner in which its 貌上，執委會應通知委員會已將其意見列入考
opinion has been taken into account. 慮。
4. The Committee may furthermore examine any 4. 委員會可以臨時討論有關任何有關本指令的

other matter relating to the implementation and
practical application of this Directive and raised 實現與實際應用的問題，問題可以由主席主
by its chairman either on his own initiative or at 動提出或某一會員國要求。
the request of a Member State.
Article 8 條款 8
Safeguard clause 保護條款
1. Where a Member State ascertains that pressure 1. 當會員國發現貼有 CE 標誌且有依據其原先目

equipment or assemblies referred to in Article 1,
bearing the CE marking and used in accordance 的在使用的壓力設備與組合設備，有可能會危
with their intended use are liable to endanger the 害到人員與必要時含家畜或財產的安全，會員
safety of persons and, where appropriate, domestic
animals or property, it shall take all appropriate 國應採取適當措施將這些壓力設備或組合設備
measures to withdraw such equipment or 從市場撤回、禁止放在市場、服務、使用或限制
assemblies from the market, prohibit the placing
on the market, putting into service or use thereof, 其自由流通。
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or restrict free movement thereof.
The Member State shall immediately inform the 會員國應立刻將其所採取的任何措施通知執委

Commission of any such measure, indicating the
reasons for its decision and, in particular, whether 會，說明其決定的理由，最重要是要說明不符
non-conformity is due to: 合是因為：
(a) failure to satisfy the essential requirements (a) 不滿足條款 3 所稱之基本要求；

referred to in Article 3;
(b)incorrect application of the standards referred to (b) 不正確應用條款 5(2)所稱之標準；

in Article 5 (2);
(c) shortcomings in the standards referred to in (c) 未完全符合條款 5(2)所稱之標準；

Article 5 (2);
(d)shortcomings in the European approval of (d)未完全符合條款 11 所稱之歐洲核准壓力設備

pressure equipment materials as referred to in
Article 11; 用材料。
2. The Commission shall enter into consultation with 2. 執委會應立刻咨詢有關的單位。咨詢以後，執委

the parties concerned without delay. Where the
Commission considers, after this consultation, that 會考量此措施是正確之後，即應立刻通知提出
the measure is justified, it shall immediately so 的會員國與其它會員國。
inform the Member State which took the initiative
and the other Member States.
Where the Commission considers, after this 執委會考量咨詢以後評估不符合規定，即應立

consultation, that the measure is unjustified, it
shall immediately so inform the Member State 刻通知提出的會員國與製造者或其建立在共同
which took the initiative and the manufacturer, or 體授權代表。第一段所談及的決定基於標準中或
his authorized representative established within the
Community. Where the decision referred to in 歐洲所承認的材料的缺失，和某一會員國在執
paragraph 1 is based on a shortcoming in the 委會上維持原來的決定，應根據條款六的規定
standards or in European approvals for materials
and where the Member State at the origin of the 時刻通知委員會，為了要根據條款六第一段的
decision maintains is position the Commission 規定起始程序。
shall immediately inform the Committee referred
to in Article 6 in order to initiate the procedure
referred to in the first paragraph of Article 6.
3. Where pressure equipment or an assembly which 3. 對不應貼有 CE 標誌的壓力設備或組合設備，

does not comply bears the CE marking, the
competent Member State shall take appropriate 有資格的會員國應採取適當行動抵制貼 CE 標
action against the person(s) having affixed the CE 誌的人，同時通知執委會與其它會員國。
marking and shall so inform the Commission and
the other Member States.
4. The Commission shall ensure that the Member 4. 執委會應確保此程序的進展與結果可隨時通知

States are kept informed of the progress and
outcome of this procedure. 會員國。
Article 9 條款 9
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Classification of pressure equipment 壓力設備的分類
1. Pressure equipment referred to in Article 3 (1) 1. 條款 3(1)所稱之壓力設備，應根據附件 II 所用

shall be classified by category in accordance with
Annex II, according to ascending level of hazard. 的種類(Category)來作分類，此種類是依危險的
程度由小到大來作分類。
For the purposes of such classification fluids shall 為達到分類的目的，流體應根據 2.1 與 2.2 分成
be divided into two groups in accordance with 2.1
and 2.2. 兩組。
2.1 Group 1 comprises dangerous fluids. A 2.1 第 1 組流體係危險性流體。危險性流體是 1967

dangerous fluid is a substance or preparation
covered by the definitions in Article 2 (2) of 年 6 月 27 日理事會 67/548/EEC 指令條款 2(2)
Council Directive 67/548/EEC of 27 June 1967 之所定義的物質或調配品，此指令是有關危險
on the approximation of the laws, regulations and
administrative provisions relating to the 性物質的分類、包裝與標示的近似法律、規則
classification, packaging and labeling of 與行政規定。
dangerous substances.
Group 1 comprises fluids defined as: 第 1 組流體由下列定義之流體所組成：
— explosive, —具爆炸性，
— extremely flammable, —極高可燃性，
— highly flammable, —高可燃性，
— flammable (where the maximum allowable — 可燃性(其最高容許溫度在燃點以上)，

temperature is above flashpoint),
— very toxic, —極毒性，
— toxic, —毒性，
— oxidizing. —氧化性。
2.2 Group 2 comprises all other not referred to in 2.1. 2.2 第 2 組流體包含所有不屬於 2.1 節的流體。
3. Where a vessel is composed of a number of 3. 由數個連通壓力室(Chamber)所構成之容器，

chambers, it shall be classified in the highest
category applicable to the individual chambers. 取個別連通壓力室的最高種類作為此組合容
Where a chamber contains several fluids, 器的種類。若一連通壓力室包含多種流體，分
classification shall be on the basis of the fluid
which requires the highest category. 類的基本原則是取各種流體的最高種類。
Article 10 條款 10
Conformity assessment
符合性評鑑
1.1 Before placing pressure equipment on the market, 1.1 將壓力設備放到市場以前，製造廠應根據本條

the manufacturer shall subject each item of
equipment to one of the conformity assessment 款所定之條件，確保每台設備實施附件 III 所
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procedures described in Annex III, according to 述之符合性評鑑程序。

the conditions given in this Article.
1.2 The conformity assessment procedures to be 1.2 要在每一台設備上貼 CE 標誌，需實施符合性

applied to an item of pressure equipment with a
view to affixing the CE marking shall be 評鑑程序，所實施的符合性評鑑程序由設備的
determined by the category, as defined in Article 種類來決定。
9, in which the equipment is classified.
1.3. The conformity assessment procedures to be 1.3 各種不同種類壓力設備的符合性評鑑程序如

applied for the various categories are as follows:
下：
－ category I －第 I 種
Module A A 模式
－ category II －第 II 種
Module A1 A1 模式
Module D1 D1 模式
Module E1 E1 模式
－ category III －第 III 種
Module B1 + D B1+D 模式
Module B1 + F B1+F 模式
Module B + E B+E 模式
Module B +C1 B+C1 模式
Module H H 模式
－ category IV －第 IV 種
Module B + D B+D 模式
Module B + F B+F 模式
Module G G 模式
Module H H1 模式
1.4. Pressure equipment shall be subjected to one of 1.4. 壓力設備應實施某一符合性評鑑程序，由製

the conformity assessment procedures which
may be chosen by the manufacturer among those 造廠依壓力設備的種類從中擇一實施。如果願
laid down for the category in which it is 意的話，製造廠也可從較高種類中從中選擇
classified. The manufacturer may also choose to
apply one of the procedures which apply to a 一個符合性評鑑程序。
higher category, if available.
1.5. In the framework of quality assurance procedures 1.5. 在條款 3 內 1.1(a)節、1.1(b)節第 1 個縮排與
for equipment in categories III and IV referred to
in Article 3, section 1.1 (a), section 1.1 (b) first 1.2 節所指之第 III 與第 IV 種設備的品質保證
indent and section 1.2, the notified body shall, 程序之架構下，當執行非預期的訪查，驗證機
when performing unexpected visits, take a
sample of equipment from the manufacturing or 構應從製造廠或儲存室取得一設備樣本以執行
storage premises in order to perform, or have
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performed, the final assessment as referred to in 附件 I 內 3.2.2 節所指之最終評估。為達此目

Annex I, section 3.2.2. To this end, the
manufacturer shall inform the notified body of 的，製造廠應將生產進度通知驗證機構。在製
the intended schedule of production. The 造的第一年期間，驗證機構應至少實施兩次的
notified body shall carry out at least two visits
during the first year of manufacturing. The 查訪。後續查訪的頻率則由驗證機構依各評鑑
frequency of subsequent visits shall be 模式 4.4 節規定的準則來決定。
determined by the notified body on the basis of
the criteria set out in section 4.4 of the relevant
modules.
1.6. In the case of one-off production of vessels and 1.6. 對條款 3 內 1.2 節所指之第 III 種容器與設備
equipment in Category III referred to in Article
3, section 1.2 under the module H procedure, the 且實施 H 模式的評鑑程序，若它生產一個就
notified body shall perform or have performed 停(One-Off Production)，驗證機構應對每一個
the final assessment, as referred to in Annex I,
section 3.2.2, for each unit. To this end, the 單元執行如附件 I 內 3.2.2 節所述的最終評估。
manufacturer shall communicate the intended 為達此目的，製造廠應將預定之生產進度通知
schedule of production to the notified body.
驗證機構。
2. Assemblies referred to in Article 3 (2) shall be 2. 對條款 3(2)所稱之組合設備應實施整體符合

subjected to a global conformity assessment
procedure comprising: 性評鑑程序，包括：
(a) assessment of each item of pressure (a) 構成組合設備的每一項壓力設備、條款

equipment making up the assembly and
referred to in Article 3 (1) which has not 3(1)所稱之壓力設備而之前尚未實施符合
been previously subjected to a conformity 評鑑程序者、與 CE 標誌分開的每一項壓
assessment procedure and to a separate CE
marking; the assessment procedure shall be 力設備之評鑑。評鑑程序應依每一項設備
determined by the category of each item of 的種類來決定；
equipment;
(b) the assessment of the integration of the (b) 評鑑組合設備內各種組件的整合性，如附

various components of the assembly as
referred to in sections 2.3, 2.8 and 2.9 of 件 I 的 2.3、2.8 與 2.9 節的要求，評鑑程序
Annex I which shall be determined by the 由設備最高種類來決定，而非安全附屬設
highest category applicable to the equipment
concerned other than that applicable to any 備之最高種類來決定；
safety accessories;
(c) the assessment of the protection of an (c) 評鑑組合設備中為防止超過容許操作限的

assembly against exceeding the permissible
operating limits as referred to in sections 保護措施，如附件 I 之 2.10 與 3.2.3 節所
2.10 and 3.2.3 of Annex I shall be conducted 述，此評鑑應以欲保護的各項壓力設備的
in the light of the highest category
applicable to the items of equipment to be 最高種類來主導。
protected.
3. By way of derogation from paragraphs 1 and 2, 3. 對低於第 1 段與第 2 段要求條件的個別壓力設

the competent authorities may, where justified,
allow the placing on the market and putting into 備與組合設備(如條款 1(2)所稱)，雖然毋須應
service in the territory of the Member State 用本條款第 1 段與第 2 段所定之評鑑程序且有
concerned of individual pressure equipment
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items and assemblies referred to in Article 1 (2), 關的實驗也未實施，如經證明適當的話，主

in respect of which the procedures referred to in
paragraphs 1 and 2 of this Article have not been 管機關仍可允許其放進市場與在會員國的領
applied and the use of which is in the interests of 土內服務。
experimentation.
4. Records and correspondence relating to 4. 符合性評鑑的記錄與文件應以共同體官方語

conformity assessment shall be drawn up in the
official language(s) of the Community which 言來書寫，根據條約規定，是由負責實施評
may be determined in accordance with the Treaty 鑑程序之機構所在地的會員國來決定，或是
by the Member State where the body responsible
for carrying out these procedures is established, 該機構可接受的語言。
or in a language accepted by that body.
European approval for materials 歐洲核准材料
1. European approval for materials, as defined in 1. 當有材料製造廠或設備製造廠請求時，應發

Article I, section 2.9, shall be issued at the
request of one or more manufacturers of 行條款 1 之 2.9 節所定義的歐洲核准材料，此
materials or equipment, by one of the notified 任務是由條款 12 之驗證機構擇一來執行。驗
bodies referred to in Article 12 specifically
designated for the task. The notified body shall 證機構應訂定與執行適當的檢驗與測試，以
determine and perform, or arrange for the 驗證材料種類是否符合本指令相對應之要
performance of, the appropriate inspections and
tests to certify the conformity of the types of 求；假如有材料在 1999 年 11 月 29 日以前已
material with the corresponding requirements of 公認可安全使用，當驗證機構在驗證此符合
this Directive; in the case of materials recognized
as being safe to use before 29 November 1999, 性時，應將現有資料列入考慮。
the notified body shall take account of the
existing data when certifying such conformity.
2. Before issuing European approval for materials, 2. 驗證機構在發行歐洲核准材料以前，應將適
the notified body shall inform the Member States
and the Commission by sending them the 當資訊通知會員國與執委會。某一會員國或執
appropriate information. Within three months, a 委會應在 3 個月以內，將此問題提交給常務
Member State or the Commission may refer the
matter to the Standing Committee set up by 委員會(由 83/189/EEC 指令之條款 5 所設立)
Article 5 of Directive 83/189/EEC, giving its 並說明其理由。在此情形下，常務委員會應以
reasons. In that case, the Committee shall issue
an opinion as a matter of urgency. 急件方式發佈其意見。
The notified body shall issue the European 必要時，驗證機構在發行歐洲核准材料時，

approval for materials taking into account, where
appropriate, the opinion of the Committee and 應將委員會的意見與提交的評論列入考慮。
the comments submitted.
3. A copy of the European approval for pressure 3. 歐洲核准之壓力設備用材料的複本應送交各
equipment materials shall be sent to the Member
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States, the notified bodies and the Commission. 會員國、各驗證機構與執委會。執委會應將其

The Commission shall publish and keep up to
date a list of European approvals for materials in 出版在歐洲共同體官方公報上並隨時保持更
the Official Journal of the European 新。
Communities.
4. The materials used for the manufacture of 4. 若製造壓力設備所使用的材料符合已公布在
pressure equipment conforming with European
approvals for materials, the references of which 歐洲共同體官方公報的歐洲核淮材料，則該
have been published in the Official Journal of the 材料可被推定符合附件 I 之基本要求。
European Communities, shall be presumed to
conform to the applicable essential requirements
of Annex I.
5. The notified body which issued the European 5. 發行歐洲核准之壓力設備用材料的驗證機
approval for pressure equipment materials shall
withdraw that approval if it finds that it should 構，若發現所核准之材料型式已被某一調和
not have been issued or if the type of materials is 標準所涵蓋，則應撤消此核准。並應立刻通知
covered by a harmonized standard. It shall
immediately inform the other Member States, the 其它會員國、驗證機構與執委會。
notified bodies and the Commission of any
withdrawal of an approval.
Notified bodies 驗證機構
1. Member States shall notify the Commission and 1. 各會員國應將其所指定實施條款 10 與條款 11

the other Member States of the bodies which
they have appointed to carry out the procedures 所述之程序的機構通知執委會與其它會員
referred to in Article 10 and Article 11, together 國，通知事項還需包括該機構被指定實施之
with the specific tasks which those bodies have
been appointed to carry out and the identification 特定任務，以及執委會指定給它的識別碼。
numbers assigned to them beforehand by the
Commission.
The Commission shall publish in the Official 執委會應將所有的驗證機構與其識別碼以及

Journal of the European Communities a list of
the notified bodies, with their identification 被通知執行的任務，出版在歐洲共同體的官
numbers and the tasks for which they have been 方公報上。執委會應確保其隨時保持更新。
notified. Commission shall ensure that this list is
kept up to date.
2. Member States shall apply the criteria set out in 2. 會員國應運用附件 IV 所設立之準則來指定驗
Annex IV for the designation of bodies. Bodies
meeting the criteria laid down in the relevant 證機構。符合相關調和標準所立的準則，可推
harmonized standards shall be presumed to fulfil 定其完全符合附件 IV 相對應的準則。
the corresponding criteria in Annex IV.
3. A Member State which has notified a body must 3. 各會員國若發現其所指定之驗證機構不再符

withdraw such notification if it finds that the
body no longer meets the criteria referred to in 合第 2 段所述之準則，必須撤消這些通知。
paragraph 2.
It shall forthwith inform the other Member States 對任何的撤消通知，必須立刻通知其它會員

and the Commission of any such withdrawal of a
notification. 國與執委會。
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Recognized third-party organizations 認可的第三者組織
1. Member States shall notify the Commission and 1. 各會員國應將其所認可執行附件 I 之 3.2.2 與

the other Member States of the third-party
organizations which they have recognized for the 3.1.3 節任務的第三者組織，通知執委會與其
purposes of the tasks referred to in Annex I, 它會員國。
sections 3.2.2 and 3.1.3.
The Commission shall publish in the Official 執委會應將這些被認可的組織與可執行的任

Journal of the European Communities a list of the 務，表列在歐洲共同體的官方公報上。執委會
recognized organizations with the tasks for which 應確保這些表列的清單隨時保持更新。
they have been recognized. The Commission
shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in 2. 會員國應運用附件 IV 所設立的準則來認可這
Annex IV for the recognition of organizations.
Organizations meeting the criteria laid down in 些組織。若該組織符合相關調和標準所定之準
the relevant harmonized standards shall be 則，則可推定該組織完全符合附件 IV 所規定
presumed to fulfil the corresponding criteria in
Annex IV. 之準則。
3. A Member State which has recognized an 3. 若發現該組織不再符合第 2 段所述之準則

organization must withdraw such recognition if it
finds that the organization no longer meets the 時，會員國應撤消其認可。並應立刻通知其它
criteria referred to in paragraph 2. 會員國與執委會。
It shall forthwith inform the other Member States 會員國應立刻撤消其認可，並應通知其他會員

and the Commission of any such withdrawal of a
recognition. 國與執委會。
User inspectorates 使用者檢查小組(User inspectorates)
1. By way of derogation from the provisions 1. 除了驗證機構可實施任務的相關規定，對條

relating to the tasks carried out by the notified
bodies, Member States may authorize in their 款 1 所稱之壓力設備與組合設備，經會員國
territory the placing on the market, and the 授權之使用者檢查小組(根據第 8 段所述之準
putting into service by users, of pressure
equipment or assemblies referred to in Article I of 則指定)實施評鑑其符合基本要求，則該會員
which conformity with the essential requirements 國可允許經由使用者將該設備放進其領土內
has been assessed by a user inspectorate
designated in accordance with the criteria 的市場且開始服務。
referred to in paragraph 8.
2. When a Member State has designated a user 2. 當某一會員國有根據本條款所設立之準則指

inspectorate in accordance with the criteria set
out in this Article, it may not, on grounds of the 定一使用者檢查小組，對於該經由使用者檢
hazards due to pressure, prohibit, restrict or 查小組實施符合評鑑性程序之設備，其它會
impede the placing on the market or putting into
24/101
service under the conditions provided for in this 員國不可以用因有壓力會產生危險的理由來

Article of pressure equipment or assemblies the
conformity of which has been assessed by a user 禁止、限制或阻礙其進入市場或開始服務。
inspectorate designated by another Member State
in accordance with the criteria set out in this
Article.
3. Pressure equipment and assemblies the 3. 由使用者檢查小組所實施之壓力設備與組合

conformity of which has been assessed by a user
inspectorate shall not bear the CE marking. 設備符合性評鑑，不可黏貼 CE 標誌。
4. The pressure equipment and assemblies referred 4. 以上的壓力設備與組合設備，只可在檢查小

to may be used only in establishments operated
by the group of which the inspectorate is part. 組是該公司經營團隊一員的公司中使用。此經
The group shall apply a common safety policy as 營團隊應運用與壓力設備、組合設備之設計、
regards the technical specifications for the
design, manufacture, inspection, maintenance and 製造、檢查、維護與使用的技術規格有關的共
use of pressure equipment and assemblies. 同安全政策。
5. The user inspectorates shall act exclusively for 5. 使用者檢查小組應不受此經營團隊的影響，

the group of which they are part.
獨立行使職權。
6. The conformity assessment procedures applicable 6. 使用者檢查小組只可實施附件 III 所述之

by user inspectorates shall be modules A1, C1, F
and G, as described in Annex III. A1、C1、F 與 G 模式的符合性評鑑程序。
7. Member States shall inform the other Member 7. 會員國應將其所授權的使用者檢查小組與指

States and the Commission which user
inspectorates they have authorized, the tasks for 定之任務，通知其它會員國與執委會，滿足
which they have been designated and, for each 第 4 段規定之公司應表列清單。
inspectorate, a list of the establishments
satisfying the provisions of paragraph 4.
8. In designating the user inspectorates, the Member 8. 在指定使用者檢查小組，會員國應運用附件

States shall apply the criteria listed in Annex V
and ensure that the group of which the V 所列之準則
inspectorate is part applies the criteria referred go
in the second sentence of paragraph 4.
9. A Member State that has authorized a user 9. 當會員國發現其授權的使用者檢查小組不再

inspectorate shall withdraw that authorization if it
finds that the user inspectorate no longer meets 符合第 8 段所指之準則時，應撤消其資格，
the criteria referred to in paragraph 8. It shall 並通知其它會員國與執委會。
inform the other Member States and the
Commission thereof.
10. The effects of this Article shall be monitored by 10. 執委會應監控本條款的影響，且在條款 20(3)
the Commission and evaluated three years after
the date specified in Article 20 (3). To this end, 指定之日期之後評估 3 年。為達此目的，各會
Member States shall forward to the Commission 員國應將實現此條款有用的資訊轉交給執委
any useful information on implementation of this
Article. If necessary the evaluation shall be 會。若有需要，此評估案可附在修正本指令的
accompanied by a proposal for amendment of the 提案上。
Directive.
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CE marking CE 標誌
1. The CE marking consists of the initials “CE” in 1. CE 標誌是依附件 VI 的模型字”CE”所構成。

accordance with the model in Annex VI.
The CE marking shall be accompanied by the 當驗證機構有驗證到生產管制面時，隨驗證

identification number, as referred to in Article 12
(1), of the notified body involved at the 機構的識別碼應放在 CE 標誌旁。
production control phase.
2. The CE marking shall be affixed in a visible, 2. 對下列設備，CE 標誌應貼在明顯、易讀且不

easily legible and indelible fashion to each
可磨滅的地方
－ item of pressure equipment referred to in －每項如條款 3(1)所述之壓力設備，或

article 3 (1), or
－ assembly referred to in Article 3 (2) －每項如條款 3(2)所述之組合設備
which is complete or is in a state permitting final 如附件 I 第 3.2 節所述，需完成最終評估或在

assessment as described in section 3.2 of Annex
I. 準備最終評估的狀態。
3. It is not necessary for the CE marking to be 3. 沒有必要在組合設備(條款 3(2))的每一項個別

affixed to each individual item of pressure
equipment making up an assembly as referred to 壓力設備上貼 CE 標誌。已擁有 CE 標誌的每
in Article 3 (2). Individual items of pressure 一項個別壓力設備與其它壓力設備組合時，
equipment already bearing the CE marking when
incorporated into the assembly shall continue to 仍然擁有此標誌。
bear that marking.
4. Where the pressure equipment or assembly is 4. 當壓力設備或組合設備還需接受其它指令要

subject to other Directives covering other aspects
which provide for the affixing of the CE 求，而這些指令也需貼 CE 標誌時，後者的
marking, the latter shall indicate that the pressure CE 標誌應指出此受檢的壓力設備或組合設備
equipment or assembly in question is also
presumed to conform to the provisions of those 同時可推定其符合其它指令的規定。
Directives.
However, should one or more of those Directives 然而，在此過渡期間，容許製造廠選擇應用

allow the manufacturer, during a transitional
period, to choose which arrangements to apply, 其中一個或一個以上的指令，其 CE 標誌應指
the CE marking shall indicate conformity only 出製造廠是應用那一個指令。在這種情況下，
with the Directives applied by the manufacturer.
In this case, the particulars of the said Directives, 指令的細節必須用文件、通知或手冊的型式來
as published in the Official Journal of the 展現，且需跟隨壓力設備或組合設備。
European Communities, must be given in the
documents, notices or instructions required by
the Directives and accompanying the pressure
equipment or assembly.
26/101
5. The affixing of markings on pressure equipment 5. 貼在壓力設備或組合設備上的標誌不可誤導

or assemblies which are likely to mislead third
parties as to the meaning or form of the CE 第三者組織對 CE 標誌的意義與型式。任何其
marking shall be prohibited. Any other marking 它標誌也可以貼在壓力設備或組合設備上，
may be affixed to pressure equipment or
assemblies provided that the visibility and 只是不可降低 CE 標誌的可見性與易讀性。
legibility of the CE marking is not thereby
reduced.
Unduly affixed CE marking 不當黏貼 CE 標誌
Without prejudice to Article 8: 對條款 8 不預設立場情況下：
(a) where a Member State establishes that the CE

marking has been affixed unduly, the (a) 當某一會員國證實 CE 標誌已被不當黏貼，製
manufacturer, or his authorized representative 造廠或其建立在共同體內授權代表應強制使
established within the Community, shall be
obliged to make the product conform as regards 產品符合 CE 標誌的規定與不再違背會員國所
the provisions concerning the CE marking and to 施加的條件；
end the infringement under the conditions
imposed by the Member State;
(b) should non-conformity persist, the Member State
must take all appropriate measures to restrict or (b) 若仍然不符合，會員國必須採取任何適當措
prohibit the placing on the market of the product 施以限制或禁止將有問題之產品放進市場，
in question or to ensure that it is withdrawn from
the market in accordance with the procedures 同時必須確認有根據條款 8 所定之程序將其
laid down in article 8. 從市場撤回。
Member State shall take appropriate measures in 各會員國應採取適當措施以鼓勵負責實施此指令

order to encourage the authorities responsible for
implementing this Directive to cooperate with each 的主管機關能相互合作，且提供彼此及執委會有
other and provide each other and the Commission 關資訊以協助本指令機能正常運作。
with information in order to assist the functioning of
this Directive.
Decisions entailing refusal or restriction 禁用或限制之決定
Any decision taken pursuant to this Directive which 任何遵循本指令所作之將壓力設備或組合設備限

restricts the placing on the marked and the putting
into service or requires the withdrawal from the 制進入市場、使用或撤消的決定，應陳述其依據的
market of pressure equipment or assemblies shall 正確立場。對這樣的決定，應立刻通知有關單位，
state the exact grounds on which it is based. Such
decision shall be notified forthwith to the party 在相關會員國強制法律要求下，同時應將可用的
concerned, who shall at the same time be informed of
27/101
the legal remedies available to him under the laws in 補救方法與實施這些補救措施的時間限制通知有

force in the Member State concerned and of the time
limits to which such remedies are subject. 關單位。
Repeal 撤消
Article 22 of Directive 76/767/EEC shall cease to 76/767/EEC 指令之條款 22 與本指令所涵蓋之壓力

apply as from 29 November 1999 in respect of
pressure equipment and assemblies covered by this 設備與組合設備有關的部分，應自 1999 年 11 月
Directive. 29 日起停止應用。
Transposition and transitional provisions 轉換與過渡性規定
1. Before 29 May 1999 Member States shall adopt 1. 各會員國應在 1999 年 5 月 29 日以前採用並公
and publish the laws, regulations and
administrative provisions necessary to comply 告符合本指令需求的法律、規則與行政規定。
with this Directive. They shall forthwith inform 公告時應立即通知執委會。
the Commission thereof.
When Member States adopt the measures 當會員國制定第一小段所述之措施時，應列

referred to in the first subparagraph, they shall
contain a reference to this Directive or shall be 入本指令的參照號碼或其它官方出版品的參
accompanied by such reference on the occasion 照號碼。參照號碼的標示方法由會員國制定。
of their official publication. The methods of
making such reference shall be laid down by
Member States.
Member States shall apply such provisions as 會員國應自 1999 年 11 月 29 日起開始適用這

from 29 November 1999.
些規定。
2. Member States shall communicate to the 2. 各會員國應將制定之國家法律之規定內容通

Commission the texts of the provisions of
national law which they adopt in the field 知執委會，此國家法律是依本指令制定。
governed by this Directive.
3. Member States must permit the placing on the 3. 各會員國在本指令的適用日期 2002 年 5 月 29

market of pressure equipment and assemblies
which comply with the regulations in force in 日以前，對之前符合其領土內之強制規定的
their territory at the date of application of this 壓力設備與組合設備，仍應允許其進入市
Directive until 29 May 2002, and permit such
equipment and assemblies to be put into service 場，且在此適用日期以後允許開始服務。
beyond that date.
Addressees of the Directive
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指令的受文者
This Directive is addressed to the Member States. 本指令送往各會員國。

Done at Brussels, 29 May 1997.
1997 年 5 月 29 日完成於布魯塞爾。
For the European Parliament For the Council
The President The President
J. M. GIL-ROBLES A. JORRITSMA LEBBINK
29/101
ANNEX I
附件 I
ESSENTIAL SAFETY REQUIREMENTS

基本安全要求(ESR)
PRELIMINARY OBSERVATIONS
初步觀察
1. The obligations arising from the essential 1. 本附件之基本要求，應用於有相當危險存在

requirements listed in this Annex for pressure
equipment also apply to assemblies where the 的壓力設備與組合設備上。
corresponding hazard exists.
2. The essential requirements laid down in the 2. 本指令所定之基本要求具強制性。基本要求僅

Directive are compulsory. The obligations laid
down in these essential requirements apply only 應用於有相當危險存在的壓力設備，而該壓
if the corresponding hazard exists for the 力設備是在製造廠訂定之條件下合法使用。
pressure equipment in question when it is used
under conditions which are reasonably
foreseeable by the manufacturer.
3. The manufacturer is under an obligation to 3. 為瞭解因壓力作用在設備上所產生的危險，

analyse the hazards in order to identify those
which apply to his equipment on account of 製造廠有義務來分析這些危險發生的原因；
pressure; he must then design and construct it 在日後壓力設備的設計與製造上，應考量這
taking account of his analysis.
些分析的結果。
4. The essential requirements are to be interpreted 4. 在闡釋與應用基本要求時，除應考量在設計

and applied in such a way as to take account of
the state of the art and current practice at the 與製造階段的工藝狀態與目前實際應用的情
time of design and manufacture as well as of 況外，為達高度的健康與安全保護，更應考
technical and economic considerations which
are consistent with a high degree of health and 慮技術與經濟層面的問題。
safety protection.
1. GENERAL 1. 概論
1.1. Pressure equipment must be designed, 1.1. 為確保壓力設備在依製造廠使用手冊或預定

manufactured and checked, and if applicable
equipped and installed, in such a way as to 條件下合理使用時的安全，壓力設備需經設
ensure its safety when put into service in 計、製造與檢驗，如適用的話，還包括組合與
accordance with the manufacturer’s
instructions, or in reasonably foreseeable 安裝。
conditions.
1.2. In choosing the most appropriate solutions, the 1.2. 為選出最適合的方案，製造廠需依下列順序

manufacturer must apply the principles set out
below in the following order: 所定之原則來考量：
－ eliminate or reduce hazards as far as is — 只要實際可行，儘可能消除或降低危

reasonably practicable,
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險，
－ apply appropriate protection measures — 運用適當的保護措施以防止無法消除之

against hazards which cannot be eliminated,
危險發生，
－ where appropriate, inform users of residual — 必要時，通知仍有危險之虞的使用者，

hazards and indicate whether it is necessary
to take appropriate special measures to 指出是否有需要採取必要的特別措施以降
reduce the risks at the time of installation 低在安裝及/或使用時期的危險。
and/ or use.
1.3. Where the potential for misuse is known or can 1.3. 已知或明顯預見有因誤用而發生潛在危險

be clearly foreseen, the pressure equipment
must be designed to prevent danger from such 時，壓力設備應設計成可防止因誤用而發生
misuse or, if that is not possible, adequate 危險，如實在無法做到，應有適當的警告，
warning given that the pressure equipment must
not be used in that way. 說明此壓力設備不可如此使用。
2. DESIGN 2. 設計
2.1. General 2.1. 概要
The pressure equipment must be properly 為確保設備在預期壽命期間的安全，需將所

designed taking all relevant factors into account
in order to ensure that the equipment will be 有相關因素列入考慮，以使此設計最適當。
safe throughout its intended life.
The design must incorporate appropriate safety 使用綜合(Comprehensive)法的設計需加入適

coefficients using comprehensive methods
which are known to incorporate adequate safety 當安全係數，綜合法是指加入足夠的安全餘
margins against all relevant failure modes in a 裕以抗衡所有相關的失效模式。
consistent manner.
2.2. Design for adequate strength 2.2 足夠強度之設計
2.2.1. The pressure equipment must be designed for 2.2.1 壓力設備需經設計，在其預期用途與其它合

loadings appropriate to its intended use and
other reasonably foreseeable operating 理可預見的操作條件下可承受其負載。需特
conditions. In particular, the following factors 別考量下列因素：
must be taken into account:
－ internal/ external pressure, — 內/外壓，
－ ambient and operational temperatures, — 外界溫度與操作溫度，
－ static pressure and mass of contents in — 操作與測試情況下內容物的靜壓與質

operating and conditions,
量，
－ traffic, wind, earthquake loading, — 交通、風力、地震負載，
－ reaction forces and moments which result — 支持物、附屬件、管路等造成之反力與反

from the supports, attachments, piping,
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etc., 力矩，
－ corrosion and erosion, fatigue, etc., — 腐蝕與侵蝕、疲勞等，
－ decomposition of unstable fluids. — 不穩定流體的分解。
Various loadings which can occur at the same 需考量各種負載同時發生，以及同時發生的

time must be considered, taking into account
the probability of their simultaneous 機率。
occurrence.
2.2.2. Design for adequate strength must be based 2.2.2 足夠強度之設計是基於：

on:
－ as a general rule, a calculation method, as — 通用法則，如 2.2.3 所述之計算法，有需

described in 2.2.3, and supplemented if
necessary by an experimental design 要時以 2.2.4 所述之實驗設計法來補充，
method as described in 2.2.4, or 或
－ an experimental design method without — 毋須計算的實驗設計法，如 2.2.4 所述，

calculation, as described in 2.24, when the
product of the maximum allowable 當最高容許壓力 PS 與容積 V 的乘積小
pressure PS and the volume V is less than 於 6,000 bar-L 或 PS-DN 的乘積小於
6,000 bar-L or the product PS-DN less
than 3,000 bar. 3,000 bar。
2.2.3. Calculation method 2.2.3 計算方法
(a) Pressure containment and other loading (a) 內壓與其它負載考量

aspects
The allowable stresses for pressure 操作情況下可預見失效模式，壓力設備
equipment must be limited having regard
to reasonably foreseeable failure modes 的容許應力需加以限制。為此需引用安
under operating conditions. To this end, 全係數，以完全消除任何因製造、實際
safety factors must be applied to eliminate
fully any uncertainty arising out of 操作條件、應力、計算模式與材料性質與
manufacture, actual operational conditions, 行為等因素所產生的不確定性。
stresses, calculation models and the
properties and behavior of the material.
These calculation methods must provide 若適用的話，計算方法需提供充分安全餘裕

sufficient safety margins consistent, where
applicable, with the requirements of section 7. 以與第 7 節要求一致。
The requirements set out above may be met 上述要求，可運用下列其中之一方法來達

by applying one of the following methods, as
appropriate, if necessary as a supplement to or 成，必要時，可用另一方法來補充或聯合 2
in combination with another method: 個方法：
—design by formula, — 公式設計，
—design by analysis, — 分析設計，
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—design by fracture mechanics; — 破壞力學設計；
(b) Resistance (b) 抵抗變形能力(Resistance)

Appropriate design calculations must be 使用適當的設計計算，以證實壓力設備的抵
used to establish the resistance of the
pressure equipment concerned. 抗變形能力。
In Particular: 特別是：
—the calculation pressures must not be less — 計算壓力不得小於最高容許壓力，同時

than the maximum allowable pressures and
take into account static head and dynamic 靜水頭壓與動態流體壓力，及不穩定流
fluid pressures and the decomposition of 體的分解壓需列入考慮。當一個容器分
unstable fluids. Where a vessel is separated
into individual pressure-containing 隔成好幾個內含壓力的壓力室
chambers, the partition wall must be (Chambers)，隔板壁厚的設計需考慮相
designed on the basis of the highest
possible chamber pressure relative to the 鄰壓力室兩側的可能最高壓力差，
lowest pressure possible in the adjoining
chamber,
—the calculation temperatures must allow for — 計算溫度需容許適當安全餘裕，

appropriate safety margins,
—the design must take appropriate account of — 最大應力與應力集中之峰值應力需保持

all possible combinations of temperature
and pressure which might arise under 在安全範圍內，
reasonably foreseeable operating conditions
for the equipment,
—the maximum stresses and peak stress — 最大壓力和壓力集中點需保持在安全範

concentrations must be kept within safe
limits, 圍內。
—the calculation for pressure containment — 耐壓計算需用到的材料性質，連同適當

must utilize the values appropriate to the
properties of the material, based on 的安全係數，所需的書面資料在第 4 節
documented data, having regard to the 都有規定。考慮下列適用的材料性質：
provisions set out in section 4 together with
appropriate safety factors. Meterial
characteristics to be considered, where
applicable, include:
—yield strength, 0.2% or 1.0% proof — 降伏強度，如降伏強度不明顯，取

strength as appropriate at calculation
temperature, 計算溫度下的 0.2% 或 1.0% 耐強度
(Proof Strength)，
—tensile strength, —抗拉強度，
—time-dependent strength, i.e. creep — 時間 - 相依 (time-dependent) 強度，

strength,
如潛變強度，
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—fatigue data, —疲勞數據，
—Young’s modulus (modulus of —楊氏模數(彈性模數)，

elasticity),
—appropriate amount of plastic strain, —適當的塑性應變量，
—impact strength, —衝擊強度，
—fracture toughness, —破裂韌性，
— appropriate joint factors must be applied — 需應用適當接頭係數，此與非破壞檢測

to the material properties depending, for
example, on the type of non-destructive 的型式、接頭的材料以及預期之操作條件
testing, the materials joined and the 相關，
operating conditions envisaged,
— the design must take appropriate account — 設計上需適當考慮所有合理可見的降級

of all reasonably foreseeable degradation
mechanisms (e.g. corrosion, creep, fatigue) (如腐蝕、潛變、疲勞)，對這些會影響設備
commensurate with the intended use of the 壽命的特殊設計因素，在 3.4 節所述的使
equipment. Attention must be drawn, in the
instructions referred to in section 3.4, to 用手冊上需編擬這些注意事項，例如：
particular features of the design which are
relevant to the life of the equipment, for
example:
—for creep: design hours of operation at —

—潛變：在特定溫度下的設計操作小
specified temperatures,
時，
—for fatigue: design number of cycles at —

—疲勞：在特定應力值下的設計循環
specified stress levels,
數，
—for corrosion: design corrosion —

—腐蝕：設計容許腐蝕量；
allowance;
(c) Stability aspects (c) 穩定性考量
Where the calculated thickness does not 當計算厚度無法支持足夠的結構穩定

allow for adequate structural stability, the
necessary measures must be taken to 性，需採取必要措施補救之，對於運輸
remedy the situation taking into account 與搬運的風險需列入考量。
the risks from transport and handling.
2.2.4. Experimental design method 2.2.4 實驗設計法
The design of the equipment may be 藉由在抽樣的代表性設備或不同類的設備上

validated, in all or in part, by an appropriate
test programme carried out on a sample 實施適當測試計畫，來對設備的設計，全部
representative of the equipment module, 或部分地加以確認。
where it exists.
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The test programme must be clearly defined 測試前，需擬定明確的測試計畫，同時為負

prior to testing and accepted by the notified
body responsible for the design conformity 責設計符合性評鑑程序的驗證機構所接受。
assessment module, where it exists.
This programme must define test conditions 此計畫需訂出測試條件以及接受或拒收的準

and criteria for acceptance or refusal. The
actual values of the essential dimensions and 則。測試前，受測件重要尺寸的實際值與材
characteristics of the materials which 料特性應先加以測量。
constitute the equipment tested shall be
measured before the test.
Where appropriate, during test, it must be 在測試期間，如有必要，應適當運用精密的

possible to observe the critical zones of the
pressure equipment with adequate 應力與應變量測儀器，儘可能觀察出此壓力
instrumentation capable of registering strains 設備的臨界區域。
and stresses with sufficient precision.
The test programme must include: 測試計畫需包括：
(a) A pressure strength test, the purpose of (a) 壓力強度測試。其目的在驗證該設備不

which is to check that, at pressure with a
defined safety margin in relation to the 會出現實質洩漏或超過規定界限的變形
maximum allowable pressure, the 量，測試壓力在相對於最高容許壓力時
equipment does not exhibit significant
leaks or deformation exceeding a 有明訂的安全餘裕。
determined threshold.
The test pressure must be determined on 測試壓力的決定是基於幾何尺寸、測試
the basis of the differences between the
values of the geometrical and material 條件下的材料特性與供設計用的值之間
characteristics measures under test 的差異。測試壓力需考慮測試溫度與設
conditions and the values used for design
purposes; it must take into account the 計溫度的差異。
differences between the test and design
temperatures;
(b) Where the risk of creep or fatigue exists, (b) 如有潛變或疲勞風險存在，依設備的使

appropriate tests determined on the basis
of the service conditions laid down for the 用條件來決定適當的測試，例如，在特
equipment, for instance hold time at 定溫度下的保持時間，在特定應力值下
specified temperatures, number of cycles
at specified stress-levels, etc., 的循環次數等；
(c) Where necessary, additional tests (c) 如有需要，有關 2.2.1 所稱之其它因素，

concerning other factors referred to in
2.2.1 such as corrosion, external damage, 像是腐蝕、外部損害等所需的額外測試
etc. 等。
2.3. Provisions to ensure safe handling and 2.3 確保搬運與操作安全之規定

operation
The method of operation specified for pressure 對壓力設備規定的操作方法，需排除任何操

equipment must be such as to preclude any
reasonably foreseeable risk in operation of the 作上可能的風險。必要時，需特別注意下列事
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equipment. Particular attention must be paid, 項：

where appropriate, to:
— closured and openings, — — 封蓋與開孔，
— dangerous discharge of pressure relief — — 危險的洩壓排放，

blow-off,
— devices to prevent physical access — — 當有壓力或真空存在時，避免實際
whilst pressure or a vacuum exists,
碰觸的裝置，
— surface temperature taking into — — 使用時的表面溫度，

consideration the intended use,
— decomposition of unstable fluids. — — 不穩定流體的分解。
In particular, pressure equipment fitted with an 特別是，有檢修門的壓力設備，需安裝自動

access door must be equipped with an automatic
or manual device enabling the user easily to 或手動裝置以讓使用者可很容易確認開啟時
ascertain that the opening will not present any 不會出現任何危險。
hazard.
Furthermore, where the opening can be operated 此外，若門可快速開啟，需安裝一裝置使當
quickly, the pressure equipment must be fitted
with a device to prevent it being opened 有壓力或溫度的危險存在時，可以防止其被
whenever the pressure or temperature of the 打開。
fluid presents a hazard.
2.4. Means of examination 2.4.檢驗法
(a) Pressure equipment must be designed and (a) 設計與製造壓力設備時，需確保所有必要

constructed so that all necessary
examinations to ensure safety can be 的檢驗可安全實施；
carried out;
(b) Means of determining the internal condition (b) 為確保設備的持續安全，需有可判定設備

of the equipment must be available, where
it is necessary to ensure the continued 內部情況的方法，如檢修孔，容許實際檢
safety of the equipment, such as access 修壓力設備內部，且安全地實施適當檢
openings allowing physical access to the
inside of the pressure equipment so that 驗；
appropriate examinations can be carried out
safely and ergonomically;
(c) Other means of ensuring the safe condition (c) 當有下列情形，為確保壓力設備安全可能

of the pressure equipment may be applied:
還需運用其它方法：
— where it is too physical internal access, —

— 實際檢修內部的孔太小，或
or
— where opening the pressure equipment —

— 開啟壓力設備對其內部有不利影響，
would adversely affect the inside, or
或
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—
— where the substance contained has been — 內容物對壓力設備的材料無害且預期
shown not to be harmful to the material
from which the pressure equipment is 無其它內部降級出現。
made and no other internal degradation
mechanisms are reasonably foreseeable.
2.5. Means of draining and venting 2.5. 洩水與排氣的方式
Adequate means must be provided for the 有需要時，對壓力設備的洩水與排氣應提供

draining and venting of pressure equipment
where necessary: 適當方法：
—to avoid harmful effects such as water — 以避免有害的反應，如水鎚、真空壓扁、

hammer, vacuum collapse, corrosion and
uncontrolled chemical reactions. All stages 腐蝕與不可控的化學反應。所有操作與測試
of operation and testing, particularly pressure 階段，特別是壓力測試時，必須要考慮，
testing, must be considered,
— to permit cleaning, inspection and —以允許安全地清掃、檢查與維護。

maintenance in a safe manner.
2.6. Corrosion or other chemical attack 2.6. 腐蝕或其它化學侵害
Where necessary, adequate allowance or 有需要時，在預期與合理可預見的使用情況

protection against corrosion or other chemical
attack must be provided, taking due account of 下，應考慮提供足夠的容許裕度或防護，以
the intended and reasonably foreseeable use. 防止腐蝕或其它化學侵害。
2.7. Wear 2.7. 磨耗
Where severe conditions of erosion or abrasion 當有沖蝕(Erosion)或磨損(Abrasion)的嚴重情

may arise, adequate measures must be taken to:
況發生，需採取下列適當措施：
— minimize that effect by appropriate design, — 藉由適當設計以減低其影響，如增加額外

e.g. additional material thickness, or by the 厚度，使用內襯板或覆面鋼材料，
use of liners or cladding materials,
— permit replacement of parts which are most — 影響最大的部分可允許置換，

affected,
— draw attention, in the instructions referred to — 為連續安全使用，在 3.4 節所述之使用手冊

in 3.4, to measures necessary for continued 上編擬所需之注意事項。
safe use.
2.8. Assemblies 2.8. 組合設備
Assemblies must be so designed that: 組合設備需設計成：
—the components to be assembled together are —組合在一起的元件，在其使用上適當且可

suitable and reliable for their duty,
靠，
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—all the components are properly integrated —所有的元件經適當地整合與組裝。

and assembled in an appropriate manner.
2.9. Provisions for filling and discharge 2.9.充填與排放之規定
Where appropriate, the pressure equipment 必要時，為確保安全填充與排放，壓力設備

must be so designed and provided with
accessories, or provision made for their fitting, 應經由設計，同時提供附屬設備或安裝的規
as to ensure safe filling and discharge in 定，特別是有下列危險時：
particular with respect to hazards such as:
(a) on filling: (a) 充填時：
— overfilling or overpressurisation having —充填過量或超壓，此與充填率以及基準

regard in particular to the filling ratio and
to vapour pressure at the reference 溫度的蒸汽壓有關，
temperature,
—instability of the pressure equipment; —壓力設備的不穩定性；
(b) on discharge: the uncontrolled release of (b) 排放時：不可控的壓力流體釋放；

the pressurized fluid;
(c) on filling or discharge: unsafe connection (c) 充填或排放時：不安全的連接與分開。

and disconnection.
2.10. Protection against exceeding the allowable 2.10 . 止超出壓力設備容許限的保護裝置

limits of pressure equipment
Where, under reasonably foreseeable 在合理可見情況下，壓力可超出壓力設備容

conditions, the allowable limits could be
exceeded, the pressure equipment must be 許限，然需安裝適當的保護裝置。除非此設
fitted with, or provision made for the fitting 備是組合設備的一部分且已有其它保護裝
of, suitable protective devices, unless the
equipment is intended to be protected by other 置。
protective devices within an assembly.
The suitable device or combination of such 適當的裝置或組合裝置需決定設備或組合設

devices must be determined on the basis of
the particular characteristics of the equipment 備的特性。
or assembly.
Suitable protective devices and combinations 適當的裝置和組合裝置包含：

thereof comprise:
(a) safety accessories as defined in Article 1, (a) 安全組件定義在條款 1 之 2.1.3 節

section 2.1.3,
(b) where appropriate, adequate monitoring (b) 合適適當的監督裝置如能適時自動或手

devices such as indicators and/ or alarms
which enable adequate action to be taken 動地運作之指示器和/或警鈴保持設備的
either automatically or manually to keep 壓力在允許範圍內。
the pressure equipment within the
allowable limits.
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2.11. Safety accessories 2.11. 安全附屬設備
2.11.1. Safety accessories must: 2.11.1 安全附屬設備需：
— be so designed and constructed as to be — 經設計與組裝，確保其使用是可靠且

reliable and suitable for their intended
duty and take into account the 合適的。若有需要，還需考慮該裝置日
maintenance and testing requirements of 後的維修與測試要求，
the devices, where applicable,
— be independent of other functions, unless — 與其它功能無關，除非其安全功能非

their safety function cannot be affected by
such other function, 得有其它功能才可動作，
— comply with appropriate design principles — 有適當且可靠的保護，以符合適用的

in order to obtain suitable and reliable
protection. These principles include, in 設計原則。這些原則包括失效 -安全模
particular, fail-safe modes, redundancy, 式，累贅性，多樣性，以及自我診斷。
diversity and self-diagnosis.
2.11.2. Pressure limiting devices 2.11.2 限制壓力裝置
These devices must be so designed that the 這些裝置需經由設計，以使壓力不會持續

pressure will not permanently exceed the
maximum allowable pressure PS; however a 超過最高容許壓力 PS ；然而，如有必
short duration pressure surge in keeping with 要，持續性的短暫壓力上衝(surge)(如 7.3
the specifications laid down in 7.3 is
allowable, where appropriate. 節所指)是允許的。
2.11.3. Temperature monitoring devices 2.11.3 溫度監視裝置
These devices must have an adequate 為安全起見，這些裝置需要有足夠響應時

response time on safety grounds, consistent
with the measurement function. 間，以符合量測功能。
2.12. External fire 2.12. 外部著火
Where necessary, pressure equipment must 有需要的話，壓力設備需經由設計或安裝合

be so designed and, where appropriate, fitted
with suitable accessories, or provision made 適附屬設備，當有外部著火的事件發生時，
for their fitting, to meet damage-limitation 可限制災害擴散，特別是不要影響其用途。
requirements in the event of external fire,
having particular regard to its intended use.
3. MANUFACTURING 3. 製造
3.1. Manufacturing procedures 3.1 製造程序
The manufacturer must ensure the competent 製造廠需應用適當技術與相關程序，以確保

execution of the provisions set out at the design
stage by applying the appropriate techniques 在設計階段所定的規定可勝任執行，特別是
and relevant procedures, especially with a view 下列規定。
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to the aspects set out below.
3.1.1. Preparation of the component parts 3.1.1 零組件的準備工作
Preparation of the component parts (e.g. 零組件的準備工作(如成型與開槽)不可有缺

forming and chamfering) must not give rise to
defects or cracks or changes in the mechanical 陷、裂縫或機械性質的改變等對壓力設備的
characteristics likely to be detrimental to the 安全性可能有所危害的因素存在。
safety of the pressure equipment.
3.1.2. Permanent joining 3.1.2 永久性接合
Permanent joints and adjacent zones must be 永久性接頭與相鄰區域不可有任何對壓力設

free of any surface or internal defects
detrimental to the safety of the equipment. 備安全性有影響的表面或內部缺陷存在。
The properties of permanent joints must meet 永久性接頭的性質必須達到接合材料規格的

the minimum properties specified for the
materials to be joined unless other relevant 最低要求，除非在設計階段有特別考慮其它
property values are specifically taken into 相關性質。
account in design calculations.
For pressure equipment, permanent joining of 對壓力設備來說，直接影響其強度的永久性

components which contribute to the pressure
resistance of equipment and components 接合需由檢定合格人員與根據合適的作業程
which are directly attached to them must be 序來實施檢查。
carried out by suitably qualified personnel
according to suitable operating procedures.
For pressure equipment in categories II, III 對第 II、III 與 IV 種壓力設備，作業的程序

and IV, operating procedures and personnel
must be approved by a competent third party 與人員必須由有資格的第三者來核定，第三
which, at the manufacturer”s discretion, may 者由製造廠自行決定，可以是：
be:
— a notified body, — 驗證機構，
— a third-party organization recognized by a — 會員國認可的第三者組織，如條款 13 所

Member State as provided for in Article 13. 述。
To carry out these approvals the third party 第三者在實施這些核定時，需執行調和標準

must perform examinations and tests as out in
the appropriate harmonized standards or 規定的檢驗與測試或同等的檢驗與測試。
equivalent examinations and tests or must
have them performed.
3.1.3. Non-destructive tests 3.1.3 非破壞試驗
For pressure equipment, non-destructive tests 對壓力設備來說，永久性接頭的非破壞檢測

of permanent joints must be carried out by
suitable qualified personnel. For pressure 必須由檢定合格的人員來實施。對第 III 與
equipment in categories III and IV, the IV 種壓力設備，非破壞檢測人員需由會員
personnel must be approved by a third-party
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organization recognized by a Member State 國認可的第三者組織所核定。

pursuant to Article 13.
3.1.4. Heat treatment 3.1.4 熱處理
Where there is risk that the manufacturing 製造過程中材料的性質有可能改變，當達到

process will change the material properties to
an extent which would impair the safety of the 某一程度可能影響壓力設備安全，當有此風
pressure equipment, suitable heat treatment 險存在時，在製程中的適當階段需應用適當
must be applied at the appropriate stage of
manufacture. 的熱處理。
3.1.5. Traceability 3.1.5 可追溯性
Suitable procedures must be established and 需制定與維護合適的程序以鑑別構成設備之

maintained for identifying the material
making up the components of the equipment 材料，從收料、生產，一直到最終測試，材
which contribute to pressure resistance by 料都得以鑑別。
suitable means from receipt, through
production, up to the final test of the
manufactured pressure equipment.
3.2. Final assessment 3.2 最終評估
Pressure equipment must be subjected to final 壓力設備必須實施下列所述之最終評估。

assessment as described below.
3.2.1. Final inspection 3.2.1 最終檢驗
Pressure equipment must undergo a final 壓力設備需進行最終檢驗，包括目視檢查，

inspection to assess visually and by
examination of the accompanying documents 與審核所附之文件是否符合本指令的要求。
compliance with the requirements of the 製造期間所實施的測試可能需要列入考慮。
Directive. Test carried out during
manufacture may be taken into account. As 只要是安全的需要，壓力設備每個部件需實
far as is necessary on safety grounds, the final 施內部與外部最終檢驗。
inspection must be carried out internally and
externally on every part of the equipment,
where appropriate in the course of
manufacture (e.g. where examination during
the final inspection is no longer possible).
3.2.2. Proof test 3.2.2 驗證測試
Final assessment of pressure equipment must 壓力設備的最終評艦需包括耐壓試驗，一般

include a test for the pressure containment
aspect, which will normally take the form of a 是使用水壓試驗，其試驗值至少為 7.4 節所
hydrostatic pressure test at a pressure at least 規定的值。
equal, where appropriate, to the value laid
down in 7.4.
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For category I series-produced pressure 對量產的第 I 種壓力設備，此測試可基於統

equipment, this test may be performed on a
statistical basis. 計來執行。
Where the hydrostatic pressure test is harmful 若水壓試驗有害或不實際，可實施其它認可

or impractical, other tests of a recognized
value may be carried out. For tests other than 的試驗。對於水壓試驗以外的試驗，額外的
the hydrostatic pressure test, additional 措施像是非破壞檢測或是其它同等確認方法
measures, such as non-destructive tests or
other methods of equivalent validity, must be 需在試驗以前實施。
applied before those tests are carried out.
3.2.3. Inspection of safety devices 3.2.3 安全裝置的檢查
For assemblies, the final assessment must also 對組合設備而言，最終評估還需包括檢查安

include a check of the safety devices intended
to check full compliance with the 全裝置，應完全符合 2.10 節所述的要求。
requirements referred to in 2.10.
3.3. Marking and labeling 3.3 標誌與標示
In addition to the CE marking referred to in 除條款 15 所稱之 CE 標誌以外，需提供以下

Article 15, the following information must be
provided: 資訊：
(a) for all pressure equipment: (a) 對所有壓力設備：
— the name and address or other means of — 製造廠的名稱與地址或其它識別方

identification of the manufacturer and,
where appropriate, of his authorized 法，必要時，包括其設在共同體內的
representative established within the 授權代表，
Community,
— the year of manufacture, — 製造年份，
— identification of the pressure equipment — 壓力設備的識別碼，像是型號、量產

according to its nature, such as type,
series or batch identification and serial 或批次識別碼與序號，
number,
— essential maximum/ minimum allowable — 重要的最大/最小容許限；

limits;
(b) depending on the type of pressure (b) 與壓力設備的型式有關，為確保安全地安

equipment, further information necessary
for safe installation, operation or use and, 裝、操作或使用，如適用時，還包括維護
where applicable, maintenance and periodic 與定期檢查，需要更多的資訊像是：
inspection such as:
— the volume V of the pressure equipment — 壓力設備在 L 的容積 V，

in L,
— the nominal size for piping DN, — 管的公稱尺寸 DN，
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— the test pressure PT applied in bar and — 測試壓力 PT(bar)與測試日期，

date,
— safety device set pressure in bar, — 設定壓力的安全裝置 bar，
— output of the pressure equipment in kW, — 壓力設備的輸出 kW，
— supply voltage in V (volts), — 電源電壓 V(volts)，
— intended use, — 用途，
— filling ratio kg/L, — 充填比 kg/L，
— maximum filling mass in kg, — 最大充填質量 kg，
— tare mass in kg, — 空桶質量 kg，
— the product group; — 產品群組；
(c) where necessary, warnings fixed to the (c) 在有需要的地方，對經驗上有可能發生誤

pressure equipment drawing attention to
misuse which experience has shown might 用的情況，將其注意事項的警語貼在壓力
occur. 設備上。
The CE marking and the required information 在壓力設備上或定在壓力設備上的資料銘牌

must be given on the pressure equipment or on a
dataplate firmly attached to it, with the 上，需有 CE 標誌與所需的資訊，除了以下的
following exceptions: 例外：
— where applicable, appropriate documentation — 在適用的地方，或可使用適當的文件

may be used to avoid repetitive marking of
individual parts such as piping components, 以避免在每一個像是管件的單獨部件上重
intended for the same assembly. This applies 複標示，對組合設備也一樣。此應用在 CE
to CE marking and other marking and
labeling referred to in this Annex; 標誌與本附件所稱之其它標誌或標示上；
— where the pressure equipment is too small, — 在壓力設備的小地方，例如附屬設

e.g. accessories, the information referred to in
(b) may be given on a label attached to that 備，在(b)所述之資訊或可標示在壓力設備
pressure equipment; 上；
— labeling or other adequate means may be — 對填充的物質，或可使用標示或其它

used for the mass to be filled and the
warnings referred to in (c), provided it 適用方法來表示與在(c)所述之警告。
remains legible for the appropriate period of
time.
3.4. Operating instructions 3.4. 操作說明書
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(a) When pressure equipment is placed on the (a) 當壓力設備放進市場時，需附操作說明

market, it must be accompanied, as far as
relevant, with instructions for the user, 書，包含所有必要安全資訊有關：
containing all the necessary safety
information relating to:
— mounting including assembling of — 包含組裝壓力設備各組件的安裝，

different pieces of pressure equipment,
— putting into service, — 上市服務，
— use, — 使用，
— maintenance including checks by the user, — 維護，包括使用者查核；
(b) Instructions must cover information affixed (b) 說明書需包括 3.3 所要求(除了量產識別
to the pressure equipment in accordance
with 3.3, with the exception of serial 碼)貼在壓力設備上的資訊，與隨附的用
identification, and must be accompanied, 以全盤瞭解該說明書所需的技術文件、工
where appropriate, by the technical
documents, drawings and diagrams 程圖與圖表；
necessary for a full understanding of these
instructions;
(c) If appropriate, these instructions must also (c) 若合適的話，說明書需同時提及因誤用產

refer to hazards arising from misuse in
accordance with 1.3 and particular features 生之危險(根據 1.3)與根據 2.2.3 特別的設
of the design in accordance with 2.2.3. 計特性。
4. MATERIALS 4. 材料
Materials used for the manufacture of pressure 除非已預知要被置換，製造壓力設備所使用

equipment must be suitable for such application
during the scheduled lifetime unless 之材料在預期生命週期需適合其應用。
replacement is foreseen.
Welding consumables and other joining 銲接消耗品與其它接合材料，無論在個別或

materials need fulfil only the relevant
requirements of 4.1, 4.2 (a) and the first 接合設備上應用一適當方式，來完全符合
paragraph of 4.3, in an appropriate way, both 4.1、4.2(a)與 4.3 第 1 段的相關要求。
individually and in a joined structure.
4.1. Materials for pressurized parts must: 4.1 承壓件材料需：
(a) have appropriate properties for all (a) 在所有操作條件(合理可預見)與測試條件

operating conditions which are reasonably
foreseeable and for all test conditions, and 下有適當的性質，特別是需要有足夠的延
in particular they should be sufficiently 性與韌性。在適當地方，材料特性需符合
ductile and tough. Where appropriate, the
characteristics of the materials must 7.5 要求。此外，有需要時，為避免脆性破
comply with the requirements of 7.5. 裂，在選用材料時需特別注意。有特殊的
Moreover, due care should be exercised in
理由而需使用脆性材料時，需採取適當的
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particular in selecting materials in order to 措施；

prevent brittle-type fracture where
necessary; where for specific reasons brittle
material has to be used appropriate
measures must be taken;
(b) be sufficiently chemically resistant to the (b) 對壓力設備內的流體有足夠的抗化學反

fluid contained in the pressure equipment;
the chemical and physical properties 應；在壓力設備的預期壽命期間，為操作
necessary for operational safety must not be 上安全所需的化學與物理性質不可有所影
significantly affected within the scheduled
lifetime of the equipment; 響；
(c) not be significantly affected by ageing; (c) 不可因時效而老化(ageing)；
(d) be suitable for the intended processing (d) 適用於其製程；

procedures;
(e) be selected in order to avoid significant (e) 有所選擇，以避免當各種不同材料放在一

undesirable effects when the various
materials are put together. 起時產生不良效果。
4.2. (a) The pressure equipment manufacturer must 4.2 (a) 壓力設備製造廠需訂出一在適當情形下所
define in an appropriate manner the values
necessary for the design calculations 需的設計計算值(如 2.2.3 節所述)，與材
referred to in 2.2.3 and the essential 料基本特性與對 4.1 節所述之情況的處
characteristics of the materials and their
treatment referred to in 4.1; 置；
(b) the manufacturer must provide in his (b) 製造廠在其技術文件上需以下列其中之一

technical documentation elements relating
to compliance with the materials 的型式，提供符合指令材料規格有關的要
specifications of the Directive in one of the 項：
following form:
— by using materials which comply with — 使用符合調和標準的材料，

harmonized standards,
— by using materials covered by a — 使用根據條款 11 所定之歐洲核准壓力

European approval of pressure
equipment materials in accordance with 設備用材料，
Article 11,
— by a particular material appraisal; — 特殊的材料鑑定；
(c) for pressure equipment in categories III and (c) 對第 III 與 IV 種壓力設備，驗證機構在符
IV, particular appraisal as referred to in the
third indent of (b) must be performed by 合評鑑程序時需實施(b)之第 3 縮排所述
the notified body in charge of conformity 之特殊鑑定。
assessment procedures for the pressure
equipment.
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4.3. The equipment manufacturer must take 4.3 設備製造廠需採取適當措施以確保使用的材

appropriate measures to ensure that the material
used conforms with the required specification. 料符合需要的規格。特別是，所有的材料都需
In particular, documentation prepared by the 取得材料製造廠確認其符合規格所準備的文
material manufacturer affirming compliance
with a specification must be obtained for all 件。
materials.
For the main pressure-bearing parts of 對第 II、III 與 IV 種壓力設備的主要承壓件，

equipment in categories II, III and IV, this must
take the form of a certificate of specific product 需取得特定產品管制的證書型式。
control.
Where a material manufacturer has an 材料製造商有適當的品質保證系統，由設立

appropriate quality-assurance system, certified
by a competent body established within the 在共同體內有資格之機構的所作的驗證，製
Community and having undergone a specific 造廠所核發之證書可推定其驗證符合本節的
assessment for materials, certificates issued by
the manufacturer are presumed to certify 相關要求。
conformity with the relevant requirements of
this section.
SPECIFIC PRESSURE EQUIPMENT 特殊壓力設備之要求

REQUIREMENTS
In addition to the applicable requirements of 第 5 節與第 6 節所涵蓋之壓力設備除適用第 1 節
sections 1 to 4, the following requirements apply to
the pressure equipment covered by sections 5 and 6. 至第 4 節的要求外，還需適用下列要求
5. FIRED OR OTHERWISE HEATED PRESSURE 5. 如條款 3(1)所稱之有過熱風險之火焰或其它熱

EQUIPMENT WITH A RISK OF
OVERHEATING AS REFERRED TO IN 源之壓力設備
ARTICLE 3 (1)
This pressure equipment includes: 此壓力設備包括：
— steam and hot-water generators as referred to — 如條款 3 第 1.2 節所稱之蒸汽與熱水產生

in Article 3, section 1.2, such as fired steam
and hot-water boilers, superheaters and 器，像是火式蒸汽與熱水鍋爐、過熱器與再
reheaters, waste-heat boilers, waste 熱器、廢熱鍋爐、焚化爐用鍋爐、電極或浸入
incineration boilers, electrode or immersion-
type electrically heated boilers, pressure 式電熱鍋爐、壓力鍋，加上其附屬設備，以
cookers, together with their accessories and 及適用的話，飼水處理與供應燃料系統也可
where applicable their systems for treatment of
feedwater and for fuel supply, and 算是，及
— process-heating equipment for other than — 除條款 3 第 1.2 節所稱之蒸汽與熱水產生器

steam and hot water generation falling under
Article 3, section 1.1, such as heaters for 以外之加熱設備，像是化工用加熱器與其它
chemical and other similar processes and 類似之製程與加壓式食品加工設備。
pressurized food-processing equipment.
This pressure equipment must be calculated, 此種設備需計算、設計與建構以避免因過熱降

designed and constructed so as to avoid to
minimize risks of a significant loss of 低其耐壓的程度。特別是在適用的地方，它需
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containment from overheating. In particular it 確保：

must be ensured, where applicable, that:
(a) appropriate means of protection are (a) 提供旁適當的保護方法以限制操作參數像

provided to restrict operating parameters such
as heat input, heat take-off and, where 是輸入之熱量、點火與在適用的地方限制其
applicable, fluid level so as to avoid any risk 水位以避免任何局部與一般性過熱風險，
of local and general overheating,
(b) sampling points are provided where (b) 提供取樣點以評估流體性質，以避免有沈

required to allow evaluation of the properties
of the fluid so as to avoid risks related to 澱與腐蝕有關之風險，
deposits and/ or corrosion,
(c) adequate provisions are made to eliminate (c) 實施適當的規定以消除因沈澱所產生的風

risks of damage from deposits,
險，
(d) means of safe removal of residual heat after (d) 提供關機後消除餘熱的方法，

shutdown are provided,
(e) steps are taken to avoid a dangerous (e) 有採取步驟以消除可燃性物質之累積與空

accumulation of ignitable mixtures of
combustible substances and air, or flame 氣混合產生爆炸之危險或是回火的危險。
blowback.
6. PIPING AS REFERRED TO IN ARTICLE 3, 6. 如條款 3 內第 1.3 節所指之管路

SECTION 1.3
Design and construction must ensure: 其設計與建構需確保：
(a) that the risk of overstressing from (a) 不會有因隨意搬動或像是凸緣、連接件、

inadmissible free movement or excessive
forces being produced, e.g. on flanges, 伸縮囊或軟管所產生之過量力，而有過應
connections, bellows or hoses, is 力的風險，可用支撐、拘束、固定、對準與
adequately controlled by means such as
support, constraint, anchoring, alignment 預張力；
and pre-tension;
(b) that where there is a possibility of (b) 在管內的液化氣體不會有發生泠凝的可能

condensation occurring inside pipes for
gaseous fluids, means are provided for 性，為避免因水鎚或腐蝕產生之危害，可
drainage and removal of deposits from low 提供一些方法排洩與消除沈積物；
areas to avoid damage from water hammer
or corrosion;
(c) that due consideration is given to the (c) 有對擾流或漩渦形成的潛在危險有適當的

potential damage from turbulence and
formation of vortices; the relevant parts of 考慮；2.7 相關部分是適用的；
2.7 are applicable;
(d) that due consideration is given to the risk of (d) 有對因管路振動產生疲勞風險的適當考

fatigue due to vibrations in pipes;
慮；
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(e) that, where fluids of Group 1 are contained (e) 在管內的第 1 組流體，應提供適當的方法
in the piping, appropriate means are
provided to isolate “take-off” pipes the size 以隔離具重大風險的起點管線；
of which represents a significant risk;
(f) that the risk of inadvertent discharge is (f) 降低無意排放的風險；在起點的固定側需

minimized; the take-off points must be
clearly marked on the permanent side, 清楚標示其流體；
indicating the fluid contained;
(g) that the position and route of underground (g) 對地下管路，在技術文件應至少要記錄其

piping is at least recorded in the technical
documentation to facilitate safe 位置與路徑，以便日後安全維修、檢查或
maintenance, inspection or repair. 修護。
7. SPECIFIC QUANTITATIVE REQUIREMENTS 7. 某些壓力設備特定量化之要求

FOR CERTAIN PRESSURE EQUIPMENT
The following provisions apply as a general 以一般性的法則來應用下列規定。然而當材料

rule. However, where they are not applied,
including in cases where materials are not 沒有明確的調合標準可應用時，製造者需處
specifically referred to and no harmonized 以適當的量測以達到相同的安全等級以上。
standards are applied, the manufacturer must
demonstrate that appropriate measures have
been taken to achieve an equivalent overall
level of safety.
This section is an integral part of Annex I. The 本節是附件 I 的一主要部分。本節所立的一些

provisions laid down in this section supplement
the essential requirements of sections 1 to 6 for 規定，對其所應用的壓力設備補充第 1 節到
the pressure equipment to which they apply. 第 6 節的基本要求。
7.1 Allowable stresses 7.1 容許應力
7.1.1. Symbols 7.1.1 符號
Re/t, yield limit, indicates the value at the Re/t ，指示在計算溫度的降伏限：

calculation temperature of:
— the upper flow limit for a material — 若材料有上、下流動限，是指上降伏限，

presenting upper and lower flow limits,
— the 1.0% proof strength of austenitic steel — 沃斯田鐵鋼與非合金鋁的 1.0%保證強度

and non-alloyed aluminium,
(proof strength)，
— the 0.2% proof strength in other cases. — 其它情況下則為 0.2%保證強度。

Rm/20 indicates the minimum value of the Rm/20 是指在 20℃時最小抗拉強度。
ultimate strength 20℃.
Rm/t designates the ultimate strength at the Rm/t 是指在計算溫度下的抗拉強度。
calculation temperature.
48/101
7.1.2. The permissible general membrane stress for 7.1.2 根據所使用材料，對主要的靜態負載與溫度

predominantly static loads and for
temperatures outside the range in which creep 在潛變範圍以外，容許的一般薄膜應力實質
is significant must not exceed the smaller of 上不可超過下列值較小者：
the following values, according to the material
used:
— in the case of ferritic steel including — 對包括正常化(正常化輥軋)鋼與不包括細

normalized (normalized rolled) steel and
excluding fine-grained steel and specially 晶粒鋼的肥粒鐵鋼與特殊熱處理鋼，為
heat-treated steel, 2/3 of Re/t and 5/12 of 2/3 之 Re/t 與 5/12 之 Rm/20；
Rm/20;
— in the case of sustenitic steel: — 對沃斯田鐵鋼：
— if its elongation after rupture exceeds — 若破裂後的伸長量超過 30%，取 2/3 之

30%, 2/3 of Rm/20
Re/t
— or, alternatively, and if its elongation —或也可以當破裂後的伸長量超過

after rupture exceeds 35%, 5/6 of R e/t and
1/3 of Rm/t. 35%，取 5/6 之 Re/t 與 1/3 之 Rm/t；
— in the case of non-alloy or low-alloy cast — 對非合金或低合金鑄鋼，取 10/19 之 1/3

steel, 10/19 of 1/3 Re/t and 1/3 of Rm/20;
Re/t 與 1/3 之 Rm/20；
— in the case of aluminium, of 2/3 Re/t; — 對鋁，取 2/3 之 Re/t；
— in the case of alumimium alloys excluding — 對不包括析出硬化合金之鋁合金，取 2/3

precipitaion hardening alloys 2/3 of R e/t and
5/12 of Rm/20. 之 Re/t 與 5/12 之 Rm/20。
7.2 Joint coefficients 7.2 接頭效率
For welded joints, the joint coefficient must not 對銲接接頭，接頭效率不可超過下列數值：

exceed the following values:
— for equipment subject to destructive and non- — 對設備之全部接頭實施破壞與非破壞檢測
destructive tests which confirm that the
whole series of joints show no significant 並確認其無實質缺陷：1，
defects: 1,
— for equipment subject to random non- — 對設備實施隨機非破壞檢測：0.85，
destructive testing: 0.85,
— for equipment not subject to non-destructive — 對設備只實施目視檢查而無實施非破壞檢
testing other than visual inspection: 0.7.
測：0.7。
If necessary, the type of stress and the 若有需要的話，應力的型式與接頭的機械與

mechanical and technological properties of the
joint must also be taken into account. 工程技術性質需同時列入考慮。
7.3 Pressure limiting devices, particularly for 7.3 壓力限制裝置，特別是壓力容器
49/101
pressure vessels
The momentary pressure surge referred to in 在 2.11.2 談到的瞬間之上沖壓力，需保持在

2.11.2 must be kept to 10% of the maximum
allowable pressure. 最高容許壓力的 10%以內。
7.4 Hydrostatic test pressure 7.4 水壓試驗壓力
For pressure vessels, the hydrostatic test 對於壓力容器，在 3.2.2 所談到的水壓試驗壓

pressure referred to in 3.2.2 must be no less
than: 力不得小於：
— that corresponding to the maximum loading — 壓力設備在使用中可能承受的最高負載乘
to which the pressure equipment may be
subject in service taking into account its 上係數 1.25，需將其最高容許壓力與最高
maximum allowable pressure and its 容許溫度列入考慮，或
maximum allowable temperature, multiplied
by the coefficient 1.25, or
The maximum allowable pressure multiplied by
最高容許壓力乘上係數 1.43，取其較大者。
the coefficient 1.43, whichever is the greater.
7.5 Material characteristics 7.5 材料特性
Unless other values are required in accordance 除非根據其它需列入考慮之準則而需要其它

with other criteria that must be taken into
account, a steel is considered ad sufficiently 的值，在溫度不大於 20℃且不高於最低的預
ductile to satisfy 4.1 (a) if, in a tensile test 期操作溫度下，以標準程序實施的拉伸試驗
carried out by a standard procedure, its
elongation after rupture is no less than 14% and 其破裂後的伸長量不小於 14%，且以 ISO V
its bending rupture energy measured on an ISO 試驗片來測量的彎曲破裂能不小於 27J，也就
V test-piece is no less than 27 J, at a
temperature not greater than 20℃ but not higher 是使用的鋼要有足夠的延性以滿足 4.1(a)。
than the lowest scheduled operating
temperature.
ANNEX II
附件 II
CONFORMITY ASSESSMENT TABLES

符合性評鑑表
1. The references in the tables to categories of 1. 表內所示之設備種類所引用之評鑑模式如

modules are the following:
下：
I = Module A I = A 模式
50/101
II = Module A1, D1, E1 II = A1、D1、E1 模式
III = Module B1+D, B1+F, B+E, B+C1, H III =B1+D、B1+F、B+E、B+C1、H 模式
IV = Module B+D, B+F, G, H1 IV = B+D、B+F、G、H1 模式
2. The safety accessories defined in Article 1, 2. 條款 1 之 2.1.3 節所定與條款 3 之 1.4 節所指的

Section 2.1.3, and referred to in Article 3,
Section 1.4,are classified in category IV. 安全附屬設備，被歸類在第 IV 種壓力設備。
However, by way of exception, safety 然而，可例外的是，製造給特定設備用的安
accessories manufactured for specific equipment
may be classified in the same category as the 全附屬設備可將其歸類與欲保護的設備相同。
equipment they protect.
3. The pressure accessories defined in Article1, 3. 條款 1 之 2.1.4 節所定與條款 3 之 1.4 節所指之

Section 2.1.4, and referred to in Article 3,
Section 1.4, are classified on the basis of: 設備壓力，以下列之基礎來歸類：
— their maximum allowable pressure PS, and — 其最高容許壓力 PS，與
— their volume V or their nominal size DN, as — 其容積 V 或其公稱尺寸 DN，與

appropriate, and
— the group of fluids for which they are — 欲使用之流體群組，

intended,
and the appropriate table for vessels or piping is 以及使用容器或管路用之適用圖表以決定使

to be used to determine the conformity 用何種符合評鑑程序。
assessment category.
Where both the volume and the nominal size are 在第 2 縮排所考慮的容積與公稱尺寸，需以
considered appropriate in the second indent, the 其中之一的最高類別來歸類。
pressure accessory must be classified in the
highest category.
4. The demarcation lines in the following 4. 下列符合性評鑑表的界線指出每一種類上限。

conformity assessment tables indicate the upper
limit for each category.
51/101
m ax. allow able pressure P S [bar]

10000.00
IV
1000.00
III
100.00
10.00
1.00
I II P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

V olum n V [l]
Table 1
表1
Vessels referred to in Article 3, Section 1.1 (a), first indent

條款 3 之 1.1(a)節第 1 縮排所稱之容器
Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of
table 1 must be classified in category III.
例外的是，對落在表 1 之第 I 或第 II 種，而內含不穩定氣體的容器，需將其歸類為第 III 種。
52/101

10000.00
IV
III
1000.00
100.00
10.00
1.00
I II P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

V olum n V [l]
Table 2
表2
Vessels referred to in Article 3, Section 1.1 (a), second indent

條款 3 之 1.1(a)節第 2 縮排所稱之容器
Exceptionally, portable extinguishers and bottles for breathing equipment must be classified at least in category
III.
例外的是，對可攜式滅火器與呼吸設備用之瓶罐，需將其歸類至少為第 III 種。
53/101

10000.00
1000.00
100.00
II
10.00
1.00
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

V olum n V [l]
Table 3
表3
Vessels referred to in Article 3, Section 1.1 (b), first indent

條款 3 之 1.1(b)節第 1 縮排所稱之容器
54/101

10000.00
II
1000.00
100.00
I
10.00
1.00
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00 100000.00

V olum n V [l]
Table 4
表4
Vessels referred to in Article 3, Section 1.1 (b), second indent

條款 3 之 1.1(b)節第 2 縮排所稱之容器
Exceptionally, assemblies intended to generating warm water as referred to in Article 3, Section 2.3, must be
subject either to an EC design examination (Module B1) with respect to their conformity with the essential
requirements referred to in Sections 2.10, 2.11, 3.4.5 (a) and 5 (d) of Annex I, or to full quality assurance
(Module H).
例外的是，如條款 3 之第 2.3 節所稱之產生溫水之組合設備，需實施 EC 設計檢驗(B1 模式)以符合附件 I
55/101
之 2.10、2.11、3.4、5(a)與 5(b)之基本要求或實施全面品質保證(H 模式)。
56/101

10000.00
1000.00
100.00
IV
10.00
1.00 II III
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

V olum n V [l]
Table 5
表5
Pressure equipment referred to in Article 3, Section 1.2

條款 3 之 1.2 節所稱之壓力設備
Exceptionally, the design of pressure-cookers must be subject to a conformity assessment procedure equivalent
to least one of the category III modules.
例外的是，壓力鍋的設計需實施至少同等於第 III 種壓力設備其中之一的符合性評鑑程序。
57/101

10000.00
1000.00
100.00
II III
10.00
1.00
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

D iam eter D N
Table 6
表6
Piping referred to in Article 3, Section 1.3 (a), first indent

條款 3 之 1.3(a)節第 1 縮排所稱之管路
Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of table 6 must
be classified in category III.
例外的是，對落在表 6 之第 I 或第 II 種，其內含不穩定之氣體者，應被歸類為第 III 種
58/101

10000.00
1000.00
100.00
II III
10.00
1.00
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

D iam eter D N
Table 7
表7
Piping referred to in Article 3, Section 1.3 (a), second indent

條款 3 之 1.3(a)節第 2 縮排所稱之管路
Exceptionally, all piping containing fluids at a temperature greater than 350℃ and falling within category II on
the basis of Table 7 must be classified in category III.
例外的是，對落在表 7 之第 II 種，所有管路內含溫度超過 350℃之流體，應將其歸類為第 III 種。
59/101

10000.00
III
1000.00
100.00
II
10.00
1.00
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

D iam eter D N
Table 8
表8
Piping referred to in Article 3, Section 1.3 (b), first indent

條款 3 之 1.3(b)節第 1 縮排所稱之管路
60/101

10000.00
II
1000.00
100.00
10.00
1.00
P S = 0 .5
0.10
0.10 1.00 10.00 100.00 1000.00 10000.00

D iam eter D N
Table 9
表9
Piping referred to in Article 3, Section 1.3 (b), second indent

條款 3 之 1.3(b)節第 2 縮排所稱之管路
61/101
ANNEX III
附件 III
CONFORMITY ASSESSMENT PROCEDURES

符合性評鑑程序
The obligations arising from the provisions on 在本附件對壓力設備的規定同樣適用於組合設備。

pressure equipment in this Annex also apply to
assemblies.
Module A (internal production control) A 模式(自我生產管制)
1. This module describes the procedure whereby the 1. 此模式說明製造廠或其設在共同體內之授權

manufacturer or his authorized representative
established within the Community who carries 代表實施第 2 節要求之任務，以確保與聲明
out the obligations laid down in section 2 ensures 壓力設備滿足指令要求之程序。製造廠或其設
and declares that pressure equipment satisfies the
requirements of the Directive which apply to it. 在共同體內之授權代表必須黏貼 CE 標誌在每
The manufacturer, or his authorized 一壓力設備項目上，及撰寫符合性聲明。
representative established within the Community,
must affix the CE marking to each item of
pressure equipment and draw up a written
declaration of conformity.
2. The manufacturer must draw up the technical 2. 製造廠需撰寫第 3 節所述之技術文件，且製

documentation described in section 3 and either
the manufacturer or his authorized representative 造廠或設在共同體內之授權代表兩者之一需
established within the Community must keep it at 保管至少 10 年，以備相關國家主管機關隨時
the disposal of the relevant national authorities
for inspection purposes for a period of ten years 檢查。
after the last of the pressure equipment has been
manufactured.
Where neither the manufacturer nor his 保管此技術文件備查，非製造廠與設在共同

authorized representative is established within the
Community, the obligation to keep the technical 體內之授權代表的責任，而是將壓力設備放
documentation available is the responsibility of 進共同體市場那個人的責任。
the person who places the pressure equipment on
the Community market.
3. The technical documentation must enable an 3. 技術文件需使壓力設備的符合性評鑑便於實

assessment to be made of the conformity of the
pressure equipment with the requirements of the 施，其需包括壓力設備的設計、製造與運轉等
Directive which apply to it. It must, as far as is 所有與評鑑有關的事項，且包括：
relevant for such assessment, cover the design,
manufacture and operation of the pressure
equipment and contain:
— a general description of the pressure －壓力設備概要敘述，

equipment,
62/101
— conceptual design and manufacturing －設計概念、製造圖、零件圖、次組合圖、電路

drawings and diagrams of components, sub-
assemblies, circuits, etc., 圖等，
— descriptions and explanations necessary for an －圖面、圖表與壓力設備的操作等不易瞭解處

understanding of the said drawings and
diagrams and the operations of the pressure 的說明與解釋，
equipment,
— a list of the standards referred to in Article 5, －表列條款 5 所述之標準的清單，不論是全

applied in full or in part, and a description of
the solutions adopted to meet the essential 部應用或僅應用一部分。當無應用條款 5 所
requirements of the Directive where the 述之標準時，應另說明為符合指令基本要
standards referred to in Article 5 have not
been applied, 求所採取之解決方案，
— results of design calculations made, －設計計算結果、檢驗結果等，

examinations carried out, etc.,
—test reports. －測試報告。
4. The manufacturer, or his authorized 4. 製造廠或其設在共同體內之授權代表需在技

must keep a copy of the declaration of conformity 術文件裏保存一份符合聲明書書的複本。
with the technical documentation.
5. The manufacturer must take all measures 5. 製造廠需採取各種必要的措施，以確保製造

necessary to ensure that the manufacturing
process requires the manufactured pressure 壓力設備的製造程序符合第 2 節的技術文件
equipment to comply with the technical 且符合所應用指令之要求。
documentation referred to in section 2 and with
the requirements of the Directive which apply to
it.
Module A1 (internal manufacturing checks with A1 模式(藉監督最終評估來查核自我生產管制)

monitoring of the final assessment)
In addition to the requirements of module A, the 除 A 模式的要求外，還包括下列各項。

following applies.
Final assessment must be performed by the 製造廠需實施最終評估，經由製造廠所選之驗證

manufacturer and monitored by means of unexpected
visits by a notified body chosen by the manufacturer. 機構不定期訪查來監督。
During such visits, the notified body must: 訪查期間，驗證機構需：
— establish that the manufacturer actually －證實製造廠有根據附件 I 第 3.2 節之規定實施最

performs final assessment in accordance with
section 3.2 of Annex 1, 終評估，
— take samples of pressure equipment at the －在製造或儲存所在地抽查幾台壓力設備。驗證機

manufacturing or storage premises in order to
conduct checks. The notified bed, assesses the 構應評估需抽幾台壓力設備以及需實施最終評
number of items of equipment to sample and
63/101
whether it is necessary to perform, or have 估的所有項目還是部分項目即可。

performed, all or part of the final assessment of the
pressure equipment samples.
Should one or more of the items of pressure 只要查到有一台或以上的壓力設備不符合，驗證

equipment not conform, the notified body must take
appropriate measures. 機構必須採取適當措施。
On the responsibility of the notified body, the 對每台壓力設備，驗證機構有責任確認製造廠需

manufacturer must affix the former's identification
number on each item of pressure equipment. 貼驗證機構的識別碼。
Module B (EC type-examination) B 模式(EC 型式檢驗)
1. This module describes the part of the procedure 1. 此模式說明驗證機構確認與證明製造廠所生

by which a notified body ascertains and attests
that a representative example of the production in 產的代表性產品符合所應用指令之規定的部
question meets the provisions of the Directive 分程序。
which apply to it.
2. The application for EC type-examination must be 2. EC 型式檢驗需由製造廠或其設在共同體內之

lodged by the manufacturer or by his authorized
representative established which the Community 授權代表向單一的驗證機構提出申請。
with a single notified body of his choice.
The application must include: 申請文件需包括：
— the name and address of the manufacturer and, －製造廠名稱與地址，如由其設在共同體內

if the application is lodged by the authorized
representative, his name and address as well, 之授權代表提出申請，則還需包括授權代
表的名稱與地址，
— a written declaration that the same application －一份書面聲明，說明該申請案未再向其它

has not been lodged with any other notified
body, 驗證機構申請，
— the technical documentation described in －第 3 節所述之技術文件。

section 3.
The application must place at the disposal of the 製造廠所生產的代表性產品，以下稱之為 ”

notified body a representative example of the
production envisaged, hereinafter called 'type'. 型式”(Type)，申請人需將其放在驗證機構要
The notified body may request further examples 求的地點。如測試規劃有所需求，驗證機構可
should the test programme so require.
要求較多樣本。
A type may cover several versions of pressure 一個型式可以包含好幾個修正版本的壓力

equipment provided that the differences between
the versions do not affect the level of safety. 設備，只要這些不同版本的壓力設備不影
響其安全性。
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assessment to be made of the conformity of the 施，其需包括壓力設備的設計、製造與操作等

pressure equipment with the requirements of the
— a general description of the type, －壓力設備的概要敘述，


equipment,

applied in full or in part, and descriptions of
— results of design calculations made , －設計計算結果、檢驗結果等，

— test reports, －測試報告，
— information concerning the tests provided for －有關製程中測試的資訊，

in manufacture,
— information concerning the qualifications or －有關附件 I 之第 3.1.2 與 3.1.3 節所需之人員

approvals required under sections 3.1.2 and
3.1.3 of Annex I. 資格檢定或核准。
4. The notified body must: 4. 驗證機構必須：
4.1. examine the technical documentation, verify that 4.1.審查技術文件，查證所製造的型式是否與技術

type has been manufactured in conformity with
it and identify the components designed in 文件相符，以及鑑定零件有依據條款 5 所述之
accordance with the relevant provisions of the 標準的相關規定來作設計與若無應用此標準時
standards referred to in Article 5, as well as those
designed without applying the provisions of 所作之設計。
those standards.
In particular, the notified body must: 特別是，驗證機構需：
— examine the technical documentation with －審查技術文件的設計與製造程序，

respect to the design and the manufacturing
procedures,
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— assess the materials used where these are not －評估不符合相關調和標準或”歐洲核准之

in conformity with the relevant harmonized
standards or with a European approval for 壓力設備用材料”的材料，與根據附件 I
pressure equipment materials, and check the 第 4.3 節核對材料製造廠出具的材質證明。
certificate issued by the material manufacturer
in accordance with section 4.3 of Annex I,
— approve the procedures for the permanent －核准壓力設備組件之永久性接合的程序，

joining of pressure equipment parts, or check
that they have been previously approved in 或根據附件 I 第 3.1.2 節核對先前所核准之
accordance with section 3.1.2 of Annex I, 程序，
— verify that the personnel undertaking the －根據附件 I 第 3.1.2 或 3.1.3 節，查證從事壓
permanent joining of pressure equipment parts
and the non-destructive tests are qualified or 力設備永久性接合與非破壞檢測之人員是
approved in accordance with sections 3.1.3. of 否具資格與經核准。
Annex I.
4.2. perform or have performed the appropriate 4.2. 當無應用條款 5 所述之標準，為證實製造廠

examinations and necessary tests to establish
whether the solutions adopted by the 所採取的解決方案符合本指令之基本要求，
manufacturer meet the essential requirement of 執行適當的檢驗與必要的測試。
the Directive where the standards referred to in
Article 5 have not been applied.
4.3. Perform or have performed the appropriate 4.3. 執行適當的檢驗與必要的測試，以證實製造

examinations and necessary tests to establish
whether, where the manufacturer has chosen to 廠所選擇應用之標準有被實際應用。
apply the relevant standards, these have actually
been applied.
4.4. Agree with the applicant the location where the 4.4. 同意申請人實施檢驗與所需之測試的地點。
examinations and necessary tests are to be
carried out.
5. Where the type satisfies the provisions of the 5. 當型式符合所應用指令的規定，驗證機構需

Directive which apply to it, the notified body
must issue an EC type-examination certificate to 頒發 EC 型式檢驗證書給申請者。此證書有效
the applicant. The certificate, which should be 期 10 年且可更新，其內容需包括製造廠的名
valid for ten years and be renewable, must
contain the name and address of the 稱與地址、檢查結論與識別所核准之型式的必
manufacturer, the conclusions of the examination 要資料。
and the necessary data for identification of the
approved type.
A list of the relevant parts of the technical 技術文件相關部分的清單必須附在證書上，

documentation must be annexed to the certificate
and a copy kept by the notified body. 且驗證機構需保有一份影本。
If the notified body refuses to issue an EC type- 如驗證機構拒發 EC 型式檢驗證書給製造廠或

examination certificate to the manufacturer or to
his authorized representative established within 其設在共同體內的授權代表，驗證機構需詳
the Community, that body must provide detailed 細說明拒發的原因。申訴程序的規定需加以制
reasons for such refusal. Provision must be made
for an appeals procedure. 定。
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6. The application must inform the notified body 6. 已核淮之壓力設備，當其 EC 型式檢驗證書的

that holds the technical documentation
concerning the EC type-examination certification 技術文件修改時，申請人需通知驗證機構；
of all modifications to the approved pressure 當所作之修改有可能影響基本要求的符合性
equipment; these are subject to additional
approval where they may affect conformity with 或先前使用條件時，需實施額外的核准。此額
the essential requirements or the prescribed 外的核准需附加到原來的 EC 型式檢驗證書。
conditions for use of the pressure equipment.
This additional approval must be given in the
form of an addition to the original EC type-
examination certificate.
7. Each notified body must communicate to the 7. 每家驗證機構對其 EC 型式檢驗證書之撤消與

Member States the relevant information
concerning EC type-examination certificates 頒發(如有要求時)，有關的資訊需通知會員
which it has withdrawn, and, on request, those it 國。
has issued.
Each notified body must also communicate to the 撤消或拒發 EC 型式檢驗證書，驗證機構應將

other notified bodies the relevant information
concerning the EC type-examination certificates 相關資訊通知其它驗證機構。
it has withdrawn or refused.
8. The other notified bodies may receive copies of 8. 其它驗證機構可能會收到 EC 型式檢驗證書與

the EC type-examination certificates and/or their
additions. The annexes to the certificates must be /或其附件的影本。其它驗證機構可自行決定
held at the disposal of the other notified bodies. 是否保存證書之附件。
9. The manufacturer, or his authorized 9. 製造廠或其設在共同體內的授權代表需保管

must keep with the technical documentation 屬於該 EC 型式檢驗證書及其附件的技術文件
copies of EC type-examination certificates and 影本至少 10 年。
their additions for a period of ten years after the
last of the pressure equipment has been
manufactured.

the person who places the product on the
Community market.
Module B1 (EC design-examination) B1 模式(EC 設計檢驗)
1. This module describes the part of the procedure 1. 此模式說明驗證機構確認與證明壓力設備的

whereby a notified body ascertains and attests
that the design of an item of pressure equipment 設計符合所應用之指令規定的部分程序。
meets the provisions of the Directive which apply
to it.
The experimental design method provided for in 附件 I 第 2.2.4 節的實驗設計法不可在此模式

section 2.2.4 of Annex I may not be used in the
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context of this module. 使用。
2. The manufacturer, or his authorized 2. EC 設計檢驗必須由製造廠或其設在共同體內

must lodge an application for EC design 之授權代表向單一的驗證機構提出申請。
examination with a single notified body.
— the name and address of the manufacturer and, －製造廠名稱與地址，如由其設在共同體內

if application is lodged by the authorized
representative, his name and address as well, 之授權代表提出申請，則還需包括授權代
表的名稱與地址，
— a written declaration that the same application －一份書面聲明，說明該申請案未再向其它

has not been lodged with any other notified
body, 驗證機構申請，
— the technical documentation described in －第 3 節所述之技術文件。

section 3.
The application may cover several versions of 此申請可包含好幾個修正版本的壓力設備，只

pressure equipment provided that the differences 要這些不同版本的壓力設備不影響其安全性。
between the versions do not affect the level of
safety.

pressure equipment with the requirements of the 施，其需包括壓力設備的設計、製造與操作等
— a general description of the type, －壓力設備的概要敘述，


equipment,

— the necessary supporting evidence for the －為確認設計方案適切性所需的支持證據，
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adequacy of the design solution, in particular 特別是當條款 5 所述之標準無完全應用

where the standards referred to in Article 5
have not been applied in full; this supporting 時；此支持證據需包括製造廠或其代表人
evidence must include the results of tests 的專責實驗室所實施的測試結果，
carried out by the appropriate laboratory of
the manufacturer or on his behalf,

— information regarding the qualifications or －有關附件 I 之第 3.1.2 與 3.1.3 節所需之人員

approvals required under sections 3.1.2 and
3.1.3 of Annex I. 資格檢定或核准。
4. The notified body must: 4. 驗證機構需：
4.1. examine the technical documentation and 4.1. 審查技術文件，以及鑑定零件有依據條款 5

identify the components which have been
designed in accordance with the relevant 所述之標準的相關規定來作設計與若無應用
provisions of the standards referred to in Article 此標準時所作之設計。
5, as well as those which have been designed
without applying the relevant provisions of those
standards.
In particular, the notified body must: 特別是，驗證機構需：
— assess the materials where these are not in －評估不符合相關調和標準或「歐洲核准之

conformity with the relevant harmonized
standards or with a European approval for 壓力設備用材料」的材料，
pressure equipment materials,
— approve the procedures for the permanent －核准壓力設備組件之永久性接合的程序，

joining of pressure equipment parts, or check
that they have been previously approved in 或根據附件 I 第 3.1.2 節核對先前所核准
accordance with section 3.1.2 of Annex I, 之程序，
— verify that the personnel undertaking the －根據附件 I 第 3.1.2 或 3.1.3 節，查證從事
permanent joining of pressure equipment
parts and the non-destructive tests are 壓力設備永久性接合與非破壞檢測之人員
qualified or approved in accordance with 是否具資格與經核准。
sections 3.1.2 and 3.1.3 of Annex I.
4.2. perform the necessary examinations to establish 4.2. 當無應用條款 5 所述之標準，為證實製造廠

whether the solutions adopted by the
manufacturer meet the essential requirements of 所採取的解決方案符合本指令之基本要求，
the Directive where the standards referred to in 執行適當的檢驗與必要的測試。
Article 5 have not been applied.
4.3. Perform the necessary examinations to establish 4.3. 執行適當的檢驗與必要的測試，以證實製造

whether, where the manufacturer has chosen to
apply the relevant standards, these have actually 廠所選擇應用之標準有被實際應用。
been applied.
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5. Where the type satisfies the provisions of the 5. 符合所應用之指令規定所作的設計，驗證機

Directive which apply to it, the notified body
must issue an EC design-examination certificate 構需頒發 EC 設計檢驗證書給申請人。證書內
to the applicant. The certificate must contain the 容需包含申請人的名稱與地址、檢驗結論、證
name and address of the applicant, the
conclusions of the examination, conditions for its 書有效條件與識別所核淮之設計所需的資料。
validity and the necessary data for identification
of the approved design.
A list of the relevant parts of the technical 技術文件相關部分的清單必須附在證書上，

documentation must be annexed to the certificate
and a copy kept by the notified body. 且驗證機構需保有一份影本。
If the notified body refuses to issue an EC 如驗證機構拒發 EC 設計檢驗證書給製造廠或

design-examination certificate to the
manufacturer or to his authorized representative 其設在共同體內的授權代表，驗證機構需詳
established within the Community, that body 細說明拒發的原因。申訴程序的規定需加以制
must provide detailed reasons for such refusal.
Provision must be made for an appeals procedure. 定。
6. The application must inform the notified body 6. 當 EC 設計檢驗證書所核准的設計有修改時，

that holds the technical documentation
concerning the EC design-examination certificate 申請人需通知保有此技術文件的驗證機構；
of all modifications to the approved design; these 當所作之修改有可能影響基本要求的符合性
are subject to additional approval where such
changes may affect the conformity of the pressure 或先前使用條件時，需實施額外的核准。此額
equipment with the essential requirements of the 外的核准需附加到原來的 EC 設計檢驗證書。
Directive or the prescribed conditions for use of
the equipment. This additional approval must be
given in the form of an addition to the original
EC design-examination certificate.
7. Each notified body must communicate to the 7. 每家驗證機構對其 EC 設計檢驗證書之撤消與

concerning EC design-examination certificates 頒發(如有要求時)，有關的資訊需通知會員
which it has withdrawn, and, on request, those it 國。
has issued.
Each notified body must also communicate to the 撤消或拒發 EC 型式檢驗證書，驗證機構應將

concerning the EC design-examination 相關資訊通知其它驗證機構。
certificates it has withdrawn or refused.
8. The other notified bodies may on request obtain 8. 其它驗證機構可要求取得下列有關資訊：

the relevant information concerning:
— the EC design-examination certificates and －EC 設計檢驗證書與新增的附件，

additions granted,
— the EC design-examination certificates and －EC 設計檢驗證書與撤消的附件。

additions withdrawn.
9. The manufacturer, or his authorized 9. 製造廠或其設在共同體內的授權代表，需保

must keep with the technical documentation 管屬於該 EC 設計檢驗證書及其附件的技術文
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referred to in section 3 copies of EC design- 件影本至少 10 年。

examination certificates and their additions for a
period of ten years after the last of the pressure
equipment has been manufactured.

authorized representative is established
the person who places the product on the
Community market.
Module C1 (conformity to type) C1 模式(符合已核淮的型式)
1. This module describes that part of the procedure 1. 此模式說明製造廠或其設在共同體內的授權

whereby the manufacturer, or his authorized
representative established within the Community, 代表確保與宣告壓力設備符合 EC 型式檢驗證
ensures and declares that pressure equipment is in 書所載的型式，且符合所應用指令的要求。製
conformity with the type as described in the EC
type-examination certificate and satisfies the 造廠或其設在共同體內的授權代表需在每個
requirements of the Directive which apply to it. 壓力設備上貼 CE 標誌與草擬一書面的符合聲
The manufacturer, or his authorized
representative established within the Community, 明書。
pressure equipment and draw up a written
declaration of conformity.
2. The manufacturer must take all measures 2. 製造廠需採取各種必要的措施，以確保製造

necessary to ensure that the manufacturing
process requires the manufactured pressure 壓力設備的製造程序符合 EC 型式檢驗證書所
equipment to comply with the type as described 載的型式且符合所應用指令的要求。
in the EC type-examination certificate and with
the requirements of the Directive which apply to
it.
3. The manufacturer, or his authorized 3. 製造廠或其設在共同體內的授權代表需保存

must keep a copy of the declaration of conformity 符合聲明書的影本至少 10 年。
for a period of ten years after the last of the
pressure equipment has been manufactured.

the person who places the pressure equipment on
the Community market.
4. Final assessment must be subject to monitoring in 4. 製造廠所選擇的驗證機構必須以不預期訪查

the form of unexpected visits by a notified body
chosen by the manufacturer. 的方式來監視最終評估。
During such visits, the notified body must: 訪查期間，驗證機構需：
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— establish that the manufacturer actually －證實製造廠有根據附件 I 第 3.2 節之規定實

performs final assessment in accordance with
section 3.2 of Annex I, 施最終評估，
— take samples of pressure equipment at the －在製造或儲存所在地抽查幾台壓力設備。驗

manufacturing or storage premises in order to
conduct checks. The notified body must 證機構應評估需抽查幾台壓力設備以及需
assess the number of items of equipment to 實施最終評估的所有項目還是部分項目即
sample and whether it is necessary to perform,
or have performed, all or part of final 可。
assessment on the pressure equipment
samples.
Should one or more of the items of pressure 只要查到有一個以上的壓力設備不符合，驗

equipment not conform, the notified body must
take appropriate measures. 證機構必須採取適當措施。
On the responsibility of the notified body, the 對每項壓力設備，驗證機構有責任確認製造

manufacturer must affix the former's
identification number on each item of pressure 廠需貼驗證機構的識別碼。
equipment.
Module D (production quality assurance) D 模式(生產品質保證)
1. This module describes the procedure whereby the 1. 此模式說明滿足第 2 節所述義務的製造廠確

manufacturer who satisfies the obligations of
section 2 ensures and declares that the pressure 保與宣告所製造的壓力設備符合 EC 型式檢驗
equipment concerned is in conformity with the 證書所載的型式或 EC 設計檢驗驗證書，同時
type described in the EC type-examination
certificate or EC design-examination certificate 符合應用指令要求的程序。製造廠或其設在共
and satisfies the requirements of the Directive 同體內的授權代表需在每台壓力設備貼 CE 標
which apply to it. The manufacturer, or his
authorized representative established within the 誌與草擬一書面的符合聲明書。在第 4 節所指
Community, must affix the CE marking to each 定之負責監督的驗證機構其識別碼需置 CE 標
item of pressure equipment and draw up a written
declaration of conformity. The CE marking must 誌旁邊。
be accompanies by the identification number of
the notified body responsible for surveillance as
specified in section 4.
2. The manufacturer must operate an approved 2. 製造廠需運作在第 3 節所述之經核淮的生產、

quality system for production, final inspection
and testing as specified in section 3 and be 最終檢驗與測試之品質系統，且接受第 4 節
subject to surveillance as specified in section 4. 所規定的監督。
3. Quality system 3. 品質系統
3.1. The manufacturer must lodge an application for 3.1. 製造廠需向驗證機構申請品質系統評鑑，此

assessment of his quality system with a notified
body of his choice. 驗證機構可自行選擇。
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— all relevant information on the pressure －所有與壓力設備有關的資訊，
equipment concerned,
— the documentation concerning the quality －品質系統文件，

system,
— the technical documentation for the approved －型式已經核准的技術文件與 EC 型式檢驗證

type and a copy of the EC type-examination
certificate or EC design-examination 書影本，或 EC 設計檢驗證書影本。
certificate.
3.2. The quality system must ensure compliance of 3.2. 品質系統需確保壓力設備符合 EC 型式檢驗
the pressure equipment with the type described in
the EC type-examination certificate or EC 證書所載的型式，或 EC 設計檢驗證書，與符
design-examination certificate and with the 合應用指令的要求。
requirements of the Directive which apply to it.
All the elements, requirements and provisions 所有製造廠所制定的要項、需求與規定需有系

adopted by the manufacturer must be documented 統且順序地在書面的政策、程序書與作業指導
in a systematic or orderly manner in the form of 書陳述。品質系統文件需與品質計畫、品質規
written policies, procedures and instructions. 劃、品質手冊與品質記錄前後一致。
This quality system documentation must permit a
consistent interpretation of the quality
programmes, plans, manuals and records.
It must contain in particular an adequate 特別是需有下列充分的說明：

description of:
— the quality objectives and the organizational －品質目標、組織架構、與壓力設備品質有關

structure, responsibilities and powers of the
management with regards to the quality of the 之管理階層權責，
pressure equipment,
— the manufacturing, quality control and quality －製程管制與所使用的品質保證技術、程序與

assurance techniques, processes and
systematic measures that will be used, 系統化措施，特別是附件 I 第 3.1.2 節需經
particularly the procedures used for the 核准的永久性接合程序，
permanent joining of parts as approved in
accordance with section 3.1.2 of Annex I,
— the examinations and tests that will be carried －需實施的進料、製程中與最終檢驗與測試以

out before, during and after manufacture, and
the frequency with which they will be carried 及其實施的頻率，
out,
— the quality records, such as inspection reports －品質記錄，如檢驗報告與測試數據、校正數

and test data, calibration data, reports
concerning the qualifications or approvals of 據、需經資格檢定或核准之人員的相關報
the personnel concerned, particularly those of 告，特別是那些根據附件 I 第 3.1.2 與 3.1.3
the personnel undertaking the joining of parts
and the non-destructive tests in accordance 節實施組件永久接合與非破壞檢測的人
with sections 3.1.2 and 3.1.3 of Annex I, 員，
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— the means of monitoring the achievement of －達到要求的品質與品質系統有效運作的監

the required quality and the effective
operation of the quality system. 督方法。
3.3. The notified body must assess the quality system 3.3. 驗證機構需評鑑製造廠品質系統以判定是否
to determine whether it satisfies the requirements
referred to in 3.2. The elements of the quality 滿足 3.2 節要求。依相關調和標準執行的品
system which conform to the relevant 質系統要項可推定其符合 3.2 節的相對要
harmonized standard are presumed to comply
with the corresponding requirements referred to 求。
in 3.2.
The auditing team must have at least one member 稽核小組至少需有一名成員有評鑑壓力設備

with experience of assessing equipment 相關技術的經驗。評鑑程序需包括到製造廠的
technology concerned. The assessment 訪視檢查。
procedure must include an inspection visit to the
manufacturer's premises.
The decision must be notified to the 評鑑結果需通知製造廠。通知事項需包含檢查

manufacturer. The notification must contain the 結果與合理的評鑑決定。申訴程序的規定需加
conclusions of the examination and the reasoned 以制定。
assessment decision. Provision must be made for
an appeals procedure.
3.4. The manufacturer must undertake to fulfil the 3.4. 製造廠需依核定的品質系統來運作，同時確

obligations arising out of the quality system as
approved and to ensure that it remains 保其持續滿意與有效。
satisfactory and efficient.
The manufacturer, or his authorized 當已核定的品質系統有任何調整，製造廠或其

representative established within the Community, 設在共同體內的授權代表需通知驗證機構。
must inform the notified body that has approved
the quality system of any intended adjustment to
the quality system.
The notified body must assess the proposed 驗證機構需評估改變的地方，以判定此修正的

changes and decide whether the amended quality
system will still satisfy the requirements referred 品質系統是否仍然滿足 3.2 節的要求或判定是
to in 3.2 or whether a reassessment is required. 否需要重評。
It must notify its decision to the manufacturer. 最後決定需通知製造廠。通知事項需包含檢

The notification must contain the conclusions of
the examination and the reasoned assessment 查結果與合理的評估決定。
decision.
4. Surveillance under the responsibility of the 4. 屬驗證機構職責的監督

notified body
4.1. The purpose of surveillance is to make sure that 4.1 監督目的在確認製造廠是否確實依核定的品

the manufacturer duly fulfils the obligations
arising out of the approved quality system. 質系統來運作。
4.2. The manufacturer must allow the notified body 4.2. 製造廠需容許驗證機構至其製造、檢查、測試
access for inspection purposes to the locations of
manufacture, inspection, testing and storage and 與儲存的所在地檢查，同時提供所有必要的
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provide it with all necessary information, in 資訊，特別是：

particular:
— the quality system documentation, －品質系統文件，
—the quality records, such as inspection reports －品質記錄，如檢驗報告與測試數據、校正數

concerning the qualifications of the personnel 據、有關人員的資格檢定報告等。
concerned, etc.
4.3. The notified body must carry out periodic audits 4.3. 驗證機構需實施定期稽核以確認製造廠有維
to make sure that the manufacturer maintains
and applies the quality system and provide the 護與應用品質系統，與提供製造廠稽核報告。
manufacturer with an audit report. The 每三年重評。
frequency of periodic audits must be such that a
full reassessment is carried out every three years.
4.4. In addition the notified body may pay 4.4. 除此之外，驗證機構可不預期訪查製造廠。是

unexpected visits to the manufacturer. The need
for such additional visits, and the frequency 否需要額外訪查與訪查的頻率，由驗證機構
thereof, will be determined on the basis of a visit 自訂的訪查管制系統來決定。訪查管制系統需
control system operated by the notified body. In
particular, the following factors must be 特別考慮下列因素：
considered in the visit control system:
— the category of the equipment, －設備種類，
— the results of previous surveillance visits, －前一次監督訪查結果，
— the need to follow up corrective action, －矯正措施是否需要追蹤，
— special conditions linked to the approval of －若適用的話，與核准系統有關的特殊狀

the system, where applicable,
況，
— significant changes in manufacturing －製造組織、政策或技術有實質改變時。

organization, policy or techniques.
During such visits the notified body may, if 訪查期間，如有需要時，驗證機構可要求實

necessary, carry out or have carried out tests to 施測試以查證品質系統是否正確運作。驗證機
verify that the quality system is functioning 構需提供訪查報告給製造廠，如有實施測
correctly. The notified body must provide the 試，還需提供測試報告。
manufacturer with a visit report and, if a test has
taken place, with a test report.
5. The manufacturer must, for a period of ten years 5. 製造廠需保管下列文件至少 10 年，以供國家

manufactured, hold at the disposal of the national 主管機關隨時抽查：
authorities:
— the documentation referred to in the second －在 3.1 節第 2 縮排所提及的文件，

indent of 3.1;
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— the adjustments referred to in the second －在 3.4 節第 2 段所提及的調整，

paragraph of 3.4;
— the decisions and reports from the notified －在 3.3、3.4 節最後 1 段與 4.3 節、4.4 節所提
body which are referred to in the last
paragraph of 3.3, the last paragraph of 3.4, 及之驗證機構的決定與報告。
and in 4.3 and 4.4.
6. Each notified body must communicate to the 6. 當某一驗證機構撤消其已核准的品質系統或

concerning the quality system approvals which it 核發品質系統(當有人要求時)時，應將所有相
has withdrawn, and, on request, those it issued. 關資訊通知各會員國。
Each notified body must also communicate to the 當某一驗證機構撤消或拒發品質系統的核淮，

other notified bodies the relevant information 應將所有相關資訊通知其它驗證機構。
concerning the quality system approvals it has
withdrawn or refused.
Module D1 (production quality assurance) D1 模式(生產品質保證)

section 3 ensures and declares that the items of 保與宣告所製造的各種壓力設備符合應用指
pressure equipment concerned satisfy the 令要求的程序。製造廠或其設在共同體內的授
requirements of the Directive which apply to
them. The manufacturer, or his authorized 權代表需在每台壓力設備貼 CE 標誌與草擬一
representative established within the Community, 書面的符合聲明書。第 5 節所述之負責監督的
pressure equipment and draw up a written 驗證機構其識別碼需置 CE 標誌旁。
declaration of conformity. The CE marking must
be accompanied by the identification number of
the notified body responsible for surveillance as
2. The manufacturer must draw up the technical 2. 製造廠需草擬下列要求的技術文件：
documentation described below.
The technical documentation must enable an 技術文件需使壓力設備符合適用指令要求的評

assessment to be made of the conformity of the 鑑便於實施，壓力設備的設計、製造與操作等
pressure equipment with the requirements of the 所有只要與評鑑有關的事項都應儘可能含括，
Directive which apply to it. It must, as far as is 同時包括：

equipment,

— description and explanations necessary for an －圖面、圖表與壓力設備的操作等不易瞭解處
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understanding of the said drawings and 的說明與解釋，

diagrams and the operation of the pressure
equipment,


— test reports. －測試報告。
3. The manufacturer must operate an approved 3. 製造廠需運作在第 4 節所述之經核准的生產、

quality system for production, final inspection
and testing as specified in section 4 and be 最終檢查與測試之品質系統，與接受第 5 節
subject to surveillance as specified in section 5. 所規定的監督。

assessment of his quality system with notified

— the documentation concerning the quality －品質系統文件。

system.
4.2. The quality system must ensure compliance of 4.2. 品質系統需確保壓力設備符合應用指令的要

the pressure equipment with the requirements of
the Directive which apply to it. 求。
All the elements, requirements and provisions 所有製造廠所制定的要項、需求與規定需有系

adopted by the manufacturer must be 統且順序地在書面的政策、程序書與作業指導
documented in a systematic and orderly manner 書陳述。品質系統文件需與品質計畫、品質規
in the form of written policies, procedures and 劃、品質手冊與品質記錄前後一致。
instructions. This quality system documentation
must permit a consistent interpretation of the
quality programmes, plans, manuals and records.
description of:

management with regards to the quality of the 之管理階層權責，
pressure equipment,
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— the manufacturing, quality control and quality －製造管制與所使用的品質保證技術、程序與

assurance techniques, processes and
systematic measures that will be used, 系統化措施，特別是附件 I 第 3.1.2 節所規
particularly the procedures used for the 定需經核准的永久性接合程序，
accordance with section 3.1.2 of Annex I,
— the examinations and tests that will be carried －需實施的進料、製程中與最終檢驗與測試以
out before, during and after manufacture, and
the frequency with which they will be carried 及其實施的頻率，
out.
— The quality records, such as inspection reports －品質記錄，如檢驗報告與測試數據、校正數

the personnel concerned, particularly those of 告，特別是那些根據附件 I 第 3.1.2 節實施
the personnel undertaking the permanent
joining of parts in accordance with section 組件永久性接合的人員，
3.1.2 of Annex I,
— The means of monitoring the achievement of －達到要求的品質與品質系統有效運作的監

the required quality and the effective
operation of the quality system. 督方法。
referred to in 4.2. The elements of the quality 滿足 4.2 節要求。依相關調和標準執行的品質
system which conform to the relevant 系統要項可推定其符合 4.2 節的相對要求。
with the corresponding requirements referred to
in 4.2.
The auditing team must have at least one member 稽核小組至少需有一名成員有評鑑壓力設備
with experience of assessing the pressure 相關技術的經驗。評鑑程序需包括到製造廠訪
equipment technology concerned. The 視檢查。
assessment procedure must include an inspection
visit to the manufacturer's premises.
manufacturer. The notification must contain the 結果與合理的評鑑決定。申訴程序的規定需加
conclusions of the examination and the reasoned 以制定。
assessment decision. Provision must be made for
an appeals procedure.

obligations arising out the quality system as
The manufacturer, or his authorized 當已核定的品質系統有任何調整，製造廠或
representative established within the 其設在共同體內的授權代表需通知驗證機構。
Community, must inform the notified body that
has approved the quality system of any intended
adjustment to the quality system.
The notified body must assess the proposed 驗證機構需評估改變的地方，以判定此修正
changes and decide whether the amended quality 的品質系統是否仍然滿足 4.2 節的要求或判定
system will still satisfy the requirements referred 是否需要重評。
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to in 4.2 or whether a reassessment is required.

If must notify its decision to the manufacturer. 最後決定需通知製造廠。通知事項需包含檢查
The notification must contain the conclusions of 結果與合理的評估決定。
the examination and the reasoned assessment
decision.

notified body
5.1. The purpose of surveillance is to make sure that 5.1. 監督目的在確認製造廠是否確實依核定的品

5.2. The manufacturer must allow the notified body 5.2. 製造廠需容許驗證機構至其製造、檢查、測試
manufacture, inspection, testing and storage and 與儲存的所在地檢查，同時提供所有必要的
provide it with all necessary information, in 資訊，特別是：
particular:
—the quality system documentation, －品質系統文件，
— the quality records, such as inspection －品質記錄，如檢驗報告與測試數據、校正數

reports and test data, calibration data, reports
concerning qualifications of the personnel 據、有關人員的資格檢定報告等。
concerned, etc.
and applies the quality system and provide the 護與應用品質系統，與提供製造廠稽核報告。
5.4. In addition the notified body may pay 5.4. 除此之外，驗證機構可不預期訪查製造廠。

for such additional visits, and the frequency 是否需要額外訪查與訪查的頻率，由驗證機
thereof, will be determined on the basis of a visit 構自訂的訪查管制系統來決定。訪查管制系統
particular, the following factors must be 需特別考慮下列因素：
— the category of the equipment; －設備種類，
— the need to follow up corrective actions, －矯正措施是否需要追蹤，

況，

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verify that the quality system is functioning 構需提供訪查報告給製造廠，如果實施測

authorities:
— the technical documentation referred to in －在第 2 節所述之技術文件，

section 2,

indent of 4.1,

paragraph of 4.4,
and in 5.3 and 5.4.

has withdrawn, and, on request, those it has 關資訊通知各會員國。
issued.
Each notified body must also communicate to the 當某一驗證機構撤消或拒發品質系統的核准，

Module E (product quality assurance) E 模式(產品品質保證)

section 2 ensures and declares that the pressure 保與宣告所製造的壓力設備符合 EC 型式檢驗
equipment is in conformity with the type as 證書所載的型式，同時滿足應用指令要求的
described in the EC type-examination certificate
and satisfies the requirements of the Directive 程序。製造廠或其設在共同體內的授權代表需
which apply to it. The manufacturer, or his 在每台產品貼 CE 標誌與草擬一書面的符合聲
Community, must affix the CE marking to each 明書。在第 4 節所指定之負責監督的驗證機構
product and draw up a written declaration of 其識別碼需置 CE 標誌旁。
conformity. The CE marking must be
accompanies by the identification number of the
notified body responsible for surveillance as
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2. The manufacturer must operate an approved 2. 製造廠需運作在第 3 節所述之經核淮的最終

quality system for the final pressure equipment
inspection and testing as specified in section 3 檢驗與測試的品質系統，且接受第 4 節所規
and be subject to surveillance as specified in 定的監督。
section 4.

assessment of his quality system for the pressure
equipment with a notified body of his choice. 驗證機構可自行選擇。
—all relevant information on the pressure －所有與壓力設備有關的資訊，

—the documentation concerning the quality －品質系統文件，
system,
— the technical documentation for the －型式已經核准的技術文件與 EC 型式檢驗證
approved type and a copy of the EC type-
examination certificate. 書影本。
3.2. Under the quality system, each item of pressure 3.2. 在品質系統的運作下，每台壓力設備需實施
equipment must be examined and appropriate
tests as set out in the relevant standard(s) 條款 5 所述之相關標準規定的檢驗與適當測
referred to in Article 5, or equivalent tests, 試，或相當的測試，特別是附件 I 第 3.2 節所
particularly final assessment as referred to in
section 3.2 of Annex I, must be carried out in 規定的最終評估一定要實施，以確保符合所
order to ensure its conformity with the 應用指令的要求。所有製造廠所制定的要項、
All the elements, requirements and provisions 需求與規定需有系統且順序地在書面的政策、
adopted by the manufacturer must be 程序書與作業指導書陳述。品質系統文件需與
documented in a systematic and orderly manner
in the form of written policies, procedures and 品質計畫、品質規劃、品質手冊與品質記錄前
instructions. This quality system documentation 後一致。

description of:
—the quality objectives and the organizational －品質目標、組織架構、與壓力設備品質有關
management with regard to the quality of the 之管理階層權責，
pressure equipment,
— the examinations and tests to be carried －最終檢驗與測試，
out after manufacture,
—the means of monitoring the effective －監督品質系統有效運作的方法，
operation of the quality system,
81/101

joining of parts and non-destructive tests in 節實施組件永久接合與非破壞檢測的人
accordance with sections 3.1.2 and 3.1.2 of 員，
Annex I.
in 3.2.
The auditing team must have at least one 稽核小組至少需有一名成員有評鑑壓力設備

member with experience of assessing the 相關技術的經驗。評鑑程序需包括到製造廠的
pressure equipment technology concerned. The 訪視檢查。
The decision must be notified to the 評鑑結果需通知製造廠。通知事項需包含檢

manufacturer. The notification must contain the
conclusions of the examination and the reasoned 驗結論與合理的評鑑決定。
assessment decision.
3.4. The manufacturer must undertake to discharge 3.4. 製造廠需依核定的品質系統來運作，同時確

the obligations arising from the quality system as

representative established within the 其設在共同體內的授權代表需通知驗證機構。
Community, must inform the notified body
which has approved the quality system of any
intended adjustment to the quality system.

charges and decide whether the modified quality
system will still satisfy the requirements referred 的品質系統是否仍然滿足 3.2 節的要求或判定
to in 3.2 or whether a reassessment is required. 是否需要重評。
It must notify its decision to the manufacturer. 最後決定需通知製造廠。通知事項需包含檢查

the examination and the reasoned assessment 結果與合理的評估決定。
decision.

notified body
4.1. The purpose of surveillance is to make sure that 4.1. 監督目的在確認製造廠是否確實依核定的品

4.2. The manufacturer must allow the notified body 4.2. 製造廠需允許驗證機構至其檢查、測試與儲存
82/101
inspection, testing and storage and provide it 的所在地檢查，同時提供所有必要的資訊，

with all necessary information, in particular:
特別是：
—the quality system documentation, －品質系統文件，

—the technical documentation, －技術文件，

concerned, etc.
to make sure that the manufacturer maintains and
applies the quality system and provide the 護與應用品質系統，與提供製造廠稽核報告。
4.4. In addition the notified body may pay unexpected 4.4. 除此之外，驗證機構可不預期訪查製造廠。是
visits to the manufacturer. The need for such
additional visits, and the frequency thereof, will 否需要額外訪查與訪查的頻率，由驗證機構
be determined on the basis of a visit control 自訂的訪查管制系統來決定。訪查管制系統需
system operated by the notified body. In
particular, the following factors must be 特別考慮下列因素：

況，

During such visits, the notified body may, if 訪查期間，如有需要時，驗證機構可要求實施

necessary, carry out or have carried out tests to 測試以查證品質系統是否正確運作。驗證機構
verify that the quality system is functioning 需提供訪查報告給製造廠，如果實施測試，還
correctly. The notified body must provide the 需提供測試報告。
5. The manufacturer must, a period of ten years 5. 製造廠需保管下列文件至少 10 年，以供國家

authorities:
—the documentation referred to in the second －在 3.1 節第 2 縮排所提及的文件，
indent of 3.1,
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—the adjustments referred to in the second －在 3.4 節第 2 段所提及的調整，

paragraph of 3.4,
—the decision and reports from the notified －在 3.3、3.4 節最後 1 段與 4.3 節、4.4 節所提
body which are referred t in the last
and in 4.3 and 4.3.

other Member States the relevant information
has withdrawn and, on request, those it has 關資訊通知各會員國。
issued.
Each notified body must also communicate to the 當某一驗證機構撤消或拒發品質系統的核准，

Module E1 (product quality assurance) E1 模式(產品品質保證)

section 3 ensures and declares that the pressure 保與宣告壓力設備符合應用指令要求的程序。
equipment satisfies the requirements of the 製造廠或其設在共同體內的授權代表需在每
Directive which apply to it. The manufacturer, or
his authorized representative established within 台壓力設備貼 CE 標誌與草擬一份書面的符合
the Community, must affix the CE marking to 聲明書。第 5 節所述之負責監督的驗證機構其
each item of pressure equipment and draw up a
written declaration of conformity. The CE 識別碼需置 CE 標誌旁邊。
marking must be accompanied by the
identification number of the notified body
responsible for surveillance as specified in
section 5.
2. The manufacturer must draw up the technical 2. 製造廠必須草擬如下要求之技術文件：

documentation described below.
The technical documentation must enable an 技術文件需使壓力設備符合適用指令要求的

pressure equipment with the requirements of the 評鑑便於實施，壓力設備的設計、製造與操作
Directive which apply to it. It must, as far as is 等所有只要與評鑑有關的事項都應儘可能含
manufacture and operation of the pressure 括，同時包括：

equipment,

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understanding of the said drawings and 的說明與解釋，

diagrams and the operation of the pressure
equipment,


— test reports. －測試報告。
3. The manufacturer must operate an approved 3. 製造廠需運作在第 4 節所述之經核淮的壓力

quality system for the final pressure equipment
inspection and testing as specified in section 4 設備最終檢驗與測試之品質系統，與接受第 5
and be subject to surveillance as specified in 節所規定的監督。
section 5.


— the documentation concerning the quality －品質系統文件。

system.
4.2. Under the quality system, each item of pressure 4.2. 在品質系統的運作下，每台壓力設備需實施
equipment must be examined and appropriate
tests as set out in the relevant standard(s) referred 條款 5 所述之相關標準規定的檢驗與適當測
to in Article 5, or equivalent tests, and 試，或相當的測試，特別是附件 I 第 3.2 節所
particularly final assessment as referred to in
section 3.2 of Annex I, must be carried out in 規定的最終評估一定要實施，以確保符合所
order to ensure its conformity with the 應用指令的要求。所有製造廠所制定的要項、
All the elements, requirements and provisions 需求與規定需有系統且順序地在書面的政策、
adopted by the manufacturer must be 程序書與作業指導書陳述。品質系統文件需與
documented in a systematic and orderly manner
in the form of written policies, procedures and 品質計畫、品質規劃、品質手冊與品質記錄前
instructions. This quality system documentation 後一致。

description of:
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pressure equipment,
— the procedures used for the permanent joining －附件 I 第 3.1.2 節規定需經核准的永久性接
of parts as approved in accordance with
section 3.1.2 of Annex 1, 合程序，
— the examinations and tests to be carried out －最終檢驗與測試，
after manufacture,
— the means of monitoring the effective －監督品質系統有效運作的方法，
operation of the quality system,
the personnel concerned, particularly those of 告，特別是那些根據附件 I 第 3.1.2 節實施
joining of parts in accordance with section 組件永久性接合的人員。
3.1.2 of Annex 1
referred to in 4.2. The elements of the quality 滿足 4.2 節要求。依相關調和標準執行的品質
system which conform to the relevant 系統要項可推定其符合 4.2 節的相對要求。
with the corresponding requirements referred to
in 4.2.
member with experience of assessing the 相關技術的經驗。評鑑程序需包括到製造廠訪
pressure equipment technology concerned. The 視檢查。
conclusions of the examination and the reasoned 結果與合理的評鑑決定。申訴程序的規定需加
assessment decision. Provision must be made 以制定。
for an appeals procedure.
4.4. The manufacturer must undertake to discharge 4.4. 製造廠需依核定的品質系統來運作，同時確

the obligations arising from the quality system as

representative established within the
Community, must inform the notified body 其設在共同體內的授權代表需通知驗證機構。
which has approved the quality system of any
intended adjustment to the quality system.

changes and decide whether the modified quality
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decision.

notified body
5.1. The purpose of surveillance is to make sure that 5.1. 監督目的在確認製造廠是否有確實依核定的

manufacturer duly fulfills the obligations arising
out of the approved quality system. 品質系統來運作。
5.2. The manufacturer must allow the notified body 5.2. 製造廠需容許驗證機構至其檢查、測試與儲
inspection, testing and storage and provide it 存的所在地檢查，同時提供所有必要的資
with all necessary information, in particular: 訊，特別是：
— the technical documentation, －技術文件，

concerned, etc.
and applies the quality system and provide the 護與應用品質系統，與提供製造廠稽核報
manufacturer with an audit report. The 告。每三年重評。

thereof, will be determined on the basis of a visit 構自訂的訪查管制系統來決定。訪查管制系
particular, the following factors must be 統需特別考慮下列因素：
— the special conditions linked to the approval －若適用的話，與核准系統有關的特殊狀

of the system, where applicable,
況，

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verify that the quality system is functioning 構需提供訪查報告給製造廠，如果實施測
manufactured, keep at the disposal of the national 主管機關隨時抽查：
authorities:
— the technical document referred to in section －在第 2 節所述之技術文件，

2,

indent of 4.1,

paragraph of 4.4,
paragraph of 4.3, the last paragraph of 4.4. 及之驗證機構的決定與報告。
and in 5.3 and 5.4.

has withdrawn and, on request, those is has 關資訊通知各會員國。
issued.
Each notified body must communicate to other 當某一驗證機構撤消或拒發品質系統的核准，

notified bodies the relevant information 應將所有相關資訊通知其它驗證機構。
Module F (product verification) 模式 F(產品查證)
1. This module describes the procedure whereby a 1. 此模式說明製造廠或其設在共同體內的授權

manufacturer, or his authorized representative
established within the Community, ensures and 代表確保與宣告壓力設備有實施第 3 節之規
declares that the pressure equipment subject to 定且符合下列證書所載之型式：
the provisions of section 3 is in conformity with
the type described;
— in the EC type-examination certificate, or －EC 型式檢驗證書，或
— in the EC design-examination certificate －EC 設計檢驗證書
and satisfied the requirements of the Directive 同時符合應用指令要求的程序。

which apply to it.
2. The manufacturer must take all measures 2. 製造廠需採取所有必要措施以確保製程使壓
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necessary to ensure that the manufacturing 力設備符合下列證書所載之型式

process requires the pressure equipment to
comply with the type described
— in the EC type-examination certificate, or －EC 型式檢驗證書，或
— in the EC design-examination certificate －EC 設計檢驗證書

and with the requirements of the Directive which 同時符合應用指令的要求。
apply to it.
The manufacturer, or his authorized 製造廠或其設在共同體內的授權代表需在所

must affix the CE marking to all pressure 有壓力設備上貼 CE 標誌，同時草擬一份符合
equipment and draw up a declaration of 聲明書。
conformity.
3. The notified body must perform the appropriate 3. 為查核壓力設備是否符合指令的相關要求，

examinations and tests in order to check the
conformity of the pressure equipment with the 驗證機構需依據第 4 節規定，對每一個產品
relevant requirements of the Directive by 執行適當的檢驗與測試。
examining and testing every product in
accordance with section 4.
The manufacturer, or his authorized 製造廠或其設在共同體內的授權代表需保管

must keep a copy of the declaration of conformity 符合聲明書的影本至少 10 年。
for a period of ten years after the last of the
pressure equipment has been manufactured.
4. Verification by examination and testing of each 4. 藉檢驗與測試每台壓力設備之驗證

item of pressure equipment
4.1. Each item of pressure equipment must be 4.1. 為查證壓力設備是否符合型式與應用指令的

individually examined and must undergo
appropriate examinations and tests as set out in 要求，每一台壓力設備需個別檢驗，與實施
the relevant standard(s) referred to in Article 5 or 條款 5 所述之相關標準所規定的檢驗與測試
equivalent examinations and tests in order to
verify that it conforms to the type and the 或同等的檢驗與測試。
In particular, the notified body must: 驗證機構需特別：
— verify that the personnel undertaking the －查證附件 I 第 3.1.2 與 3.1.3 節所規定進行永
permanent joining of parts of the non-
destructive tests are qualified or approved in 久性組件接合與非破壞檢測的人員是否具
accordance with sections 3.1.2 and 3.1.3 of 資格與經核准，
Annex I,
— verify the certificate issued by the materials －查證附件 I 第 4.3 節規定的材質證明，

manufacturer in accordance with section 4.3
of Annex I,
— carry out or have carried out the final －實施附件 I 第 3.2 節所述的最終檢驗與耐壓
inspection and proof test referred to in section
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3.2 of Annex I and examine the safety 試驗，如適用時，包括檢查安全設備。

devices, if applicable.
4.2. The notified body must affix its identification 4.2. 驗證機構需在每一台壓力設備上貼其識別
number or have it affixed to each item of
pressure equipment and draw up a written 碼，同時就所實施的測試草擬一份書面的合
certificate of conformity relating to the tests 格證書。
carried out.
4.3. The manufacturer, or his authorized 4.3. 製造廠或其設在共同體內的授權代表需確保

Community, must ensure that the certificates of 驗證機構所核發的合格證書，當有人要求時
conformity issued by the notified body can be 可隨時提出。
made available on request.
Module G (EC unit verification) G 模式(EC 單元查證)
1. This module describes the procedure whereby the 1. 此模式說明製造廠確保與宣告已有 4.1 節所述
manufacturer ensures and declares that pressure
equipment which has been issued with the 證書的壓力設備符合應用指令要求的程序。製
certificate referred to in section 4.1 satisfies the 造廠需在壓力設備上貼 CE 標誌，同時草擬一
The manufacturer must affix the CE marking to 份合格聲明。
the pressure equipment and draw up a declaration
of conformity.
2. The manufacturer must apply to a notified body 2. 製造廠需向驗證機構申請單元驗證，此驗證

of his choice for unit verification.
機構可自行選擇。
The application must contain: 申請文件需包含：
— the name and address of the manufacturer and －製造廠的名稱與地址與壓力設備的放置地

the location of the pressure equipment,
點，
— a written declaration to the effect that a similar －一份書面聲明，說明同樣的申請案未再向

application has not been lodged with another
notified body, 其它驗證機構申請，
— technical documentation. －技術文件。
3. The technical documentation must enable the 3. 技術文件需說明壓力設備如何符合應用的指

conformity of the pressure equipment with the
requirements of the Directive which apply to it to 令，與如何設計、製造與操作。
be assessed and the design, manufacturer and
operation of the pressure equipment to be
understood.
The technical documentation must contain: 技術文件必須包括：
—a general description of the pressure －壓力設備概要敘述，
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equipment,


diagrams and the operation of the pressure 的說明與解釋，
equipment,
— a list of standards referred to in Article 5, －表列條款 5 所述之標準的清單，不論是全


— test reports, －測試報告，
— appropriate details relating to the approval of －有關附件 I 第 3.1.2 與 3.1.3 節所規定的製造

the manufacturing and test procedures and of
the qualifications or approvals of the 與檢測程序的核准與人員的資格檢定或核
personnel concerned in accordance with 准的詳細說明。
sections 3.1.2 and 3.1.3 of Annex I.
4. The notified body must examine the design and 4. 為確保每台壓力設備符合應用指令的要求，

construction of each item of pressure equipment
and during manufacture perform appropriate tests 驗證機構需檢查每台壓力設備的設計與製
as set out in the relevant standard(s) referred to in 造，製造期間，執行條款 5 所述相關標準所
Article 5 of the Directive, or equivalent
examinations and tests, to ensure its conformity 規定的測試，或同等的檢驗與測試。
with the requirements of the Directive which
apply to it.
In particular the notified body must: 特別是，驗證機構需：
— examine the technical documentation with －檢查技術文件內容是否與實際設計、製造程

respect to the design and the manufacturing
procedures, 序相符，
— assess the materials used where these are not －當使用的材料不符合相關調和標準或歐洲

in conformity with the relevant harmonized
standards or with a European approval for 核准壓力設備用材料，評估其適用性，與
pressure equipment materials, and check the 核對附件 I 第 4.3 節規定的材質證明，
certificate issued by the material manufacturer
in accordance with section 4.3 of Annex 1,
— approve the procedures for the permanent －核准附件 I 第 3.1.2 節規定之組件永久性接

joining of parts or check that they have been
previously approved in accordance with 合的程序或核對先前核准的程序，
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section 3.1.2 of Annex I,
— verify the qualifications or approvals required －查證附件 I 第 3.1.2 與 3.1.3 規定的資格檢定

under sections 3.1.2 and 3.1.3 of Annex I,
或核准，
— carry out the final inspection referred to in －實施附件 I 第 3.2.1 節所述的最終檢驗、附件

section 3.2.1 of Annex I, perform or have
performed the proof test referred to in section I 第 3.2.2 節所述的耐壓試驗，如適用時，
3.2.2 of Annex I, and examine the safety 還包括檢查安全裝置，
devices, if applicable.
4.1 The notified body must affix its identification 4.1. 驗證機構需在壓力設備上貼其識別碼，同時
number or have it affixed to the pressure
equipment and draw up a certificate of 就所實施的測試草擬一份合格證書。此證書至
conformity for the tests carried out. This 少需保存 10 年。
certificate must be kept for a period of ten years.
4.2 The manufacturer, or his authorized 4.2. 製造廠或其設在共同體內的授權代表需確保

must ensure that the declaration of conformity 符合聲明書與驗證機構所核發的合格證書，
and certificate of conformity issued by the 當有人要求時可隨時提出。
notified body can be made available on request.
Module H (full quality assurance) H 模式(全面品質保證)
1. This module describe the procedure whereby the 1. 此模式說明滿足第 2 節所述義務的製造廠確

section 2 ensures and declares that the pressure 保與宣告壓力設備符合應用指令要求的程序。
equipment in question satisfies the requirements 製造廠或其設在共同體內的授權代表需在每
of the Directive which apply to it. The
manufacturer, or his authorized representative 台壓力設備貼 CE 標誌與草擬一份書面的符合
established within the Community, must affix the 聲明書。第 4 節所述之負責監督的驗證機構其
CE marking to each item of pressure equipment
and draw up a written declaration of conformity. 識別碼需置 CE 標誌旁。
The CE marking must be accompanied by the
identification number of the notified body
responsible for surveillance as specified in
section 4.
2. The manufacturer must implement an approved 2. 製造廠需實施在第 3 節所述之經核淮的含設

quality system for design, manufacture, final
inspection and testing as specified in section 3 計、製造、最終檢驗與測試的品質系統，且接
and be subject to surveillance as specified in 受第 4 節所規定的監督。
section 4.
3.1. The manufacturer must lodge an application for 3.1. 製造廠需驗證機構申請品質系統評鑑，此驗

body of his choice. 證機構可自行選擇。
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—all relevant information concerning the －所有與壓力設備有關的資訊，

pressure equipment in question,
—the documentation concerning the quality －品質系統文件。

system.
3.2. The quality system must ensure compliance of 3.2. 品質系統需確保壓力設備符合應用指令的要

the pressure equipment with the requirements of
the Directive which apply to it. 求。
All the elements, requirements and previsions 所有製造廠所制定的要項、需求與規定需有系

adopted by the manufacturer must be
documented in a systematic and orderly manner 統且順序地在書面的政策、程序書與作業指導
in the form of written policies, procedures and 書陳述。品質系統文件需與品質計畫、品質規
instructions. This quality system documentation
must permit a consistent interpretation of the 劃、品質手冊與品質記錄前後一致。
procedural and quality measures such as
programmes, plans, manuals and records.

description of:

design and to product quality,
— the technical design specifications, including －所應用的技術設計規格與標準，以及當條

standards, that will be applied and, where the
standards referred to in Article 5 are not 款 5 所述標準無法全部應用時，為確保符
applied in full, the means that will be used to 合其應用指令基本要求所使用的方法，
ensure that the essential requirements of the
Directive which apply to the pressure
equipment will be met,
— the design control and design verification －在設計壓力設備時，所使用的設計管制與

techniques, processes and systematic
measures that will be sued when designing the 設計查證技術、過程與系統化措施，特別是
pressure equipment, particularly with regard 在附件 I 第 4 節所所規定的材料，
to materials in accordance with section 4 of
Annex I,
— the corresponding manufacturing, quality －對應到製造，所使用的品質管制與品質保

control and quality assurance techniques,
processes and systematic measures that will 證技術、過程與系統化措施，特別是附件 I
be used, particularly the procedures for the 第 3.1.2 節規定需經核准的組件永久性接合
accordance with section 3.1.2 of Annex I, 程序，
— the examinations and tests to be carried out －進料、製程中與最終檢驗與測試以及其實施

before, during, and after manufacture, and the
frequency with which they will be carried out, 的頻率，
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joining of parts and the non-destructive tests 節實施永久性接合與非破壞檢測的人員，
in accordance with sections 3.1.2 and 3.1.3 of
Annex I,
— the means of monitoring the achievement of －達到要求的壓力設備設計、品質與品質系統

the required pressure equipment design and
quality and the effective operation of the 有效運作的監督方法。
quality system.
in 3.2.

member with experience of assessing the
pressure equipment technology concerned. The 相關技術的經驗。評鑑程序需包括到製造廠的
assessment procedure must include an inspection 訪視檢查。
The decision must be notified to the 評鑑結果需通知製造廠。通知事項需包含檢驗

conclusions of the examination and the reasoned 結論與合理的評鑑決定。申訴程序的規定需加
assessment decision. Provision must be made 以制定。
for an appeals procedure.

obligations arising out of the quality system as

Community, must inform the notified body that 其設在共同體內的授權代表需通知驗證機構。
has approved the quality system of any intended
adjustment to the quality system.

changes and decide whether the modified quality

94/101
decision.

notified body
4.1. The purpose of this surveillance is to make sure 4.1. 監督目的在確認製造廠是否確實依核定的品

that the manufacturer duly fulfils the obligations
4.2. The manufacturer must allow the notified body 4.2. 製造廠需允許驗證機構至其設計、製造、檢
design, manufacture, inspection, testing and 查、測試與儲存的所在地檢查，同時提供所
storage and provide it with all necessary 有必要的資訊，特別是：
information, in particular:
— the quality records provided for in the design －品質系統設計部分所需的品質記錄，如分

part of the quality system, such as results of
analyses, calculations, tests, etc., 析、計算與測試結果等，
— the quality records provided for in the －品質系統製造部分所需的品質記錄，如檢

manufacturing part of the quality system, such
as inspection reports and test data, calibration 查報告與測試數據、校正數據、有關人員的
data, reports concerning the qualifications of 資格檢定報告等。
the personnel concerned, etc.
and applies the quality system and provide the 護與應用品質系統，與提供製造廠稽核報
manufacturer with an audit report. The 告。每三年重評。

thereof, will be determined on the basis of a visit 構自訂的訪查管制系統來決定。訪查管制系
particular, the following factors must be 統需特別考慮下列因素：

況，
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necessary, carry out or have carried out tests to
verify that the quality system is functioning 施測試以查證品質系統是否正確運作。驗證機
correctly. The notified body must provide the 構需提供訪查報告給製造廠，如果實施測
taken place, with a test report. 試，還需提供測試報告。

manufactured, keep at the disposal of the national 主管機關隨時抽查：
authorities:
indent of the second subparagraph of 3.1;
subparagraph of 3.4;
subparagraph of 3.3, the last subparagraph of 及之驗證機構的決定與報告。
3.4, and in 4.3 and 4.4.

has withdrawn, and, on request, those it has 關資訊通知各會員國。
issued.
Each notified body must also communicate to the 當某一驗證機構撤消或拒發品質系統的核

concerning the quality system approvals it has 准，應將所有相關資訊通知其它驗證機構。
Module H1 (full quality assurance with design H1 模式(含設計檢查與特殊的最終評估監督的

examination and special surveillance of the final
assessment) 全面品質保證)
1. In addition to the requirements of module H, the 1. 除 H 模式的要求，還需應用下列事項：

following apply:
(a) the manufacturer must lodge an application (a) 製造廠需向驗證機構申請設計檢查；

for examination of the design with the
notified body;
(b) the application must enable the design, (b) 申請文件需使壓力設備的設計、製造與操作

equipment to be understood, and enable 能被瞭解，且供評估壓力設備符合指令相
conformity with the relevant requirements of 關要求。
the Directive to be assessed.
96/101
It must include: 需包括：
— the technical design specifications, －應用的技術設計規範與標準，

including standards, which have been
applied,
— the necessary supporting evidence for －支持其適當性所需的證據，特別是條款 5

their adequacy, in particular where the
standards referred to in Article 5 have not 所述標準無法完全應用時。支持證據需包括
been applied in full. This supporting 測試結果，此測試需由製造廠或其認可的
evidence must include the results of tests
carried out by the appropriate laboratory 實驗室實施；
of the manufacturer or on his behalf;
(c) the notified body must examine the (c) 驗證機構需審查申請文件，若設計部分符

application and where the design meets the
provisions of the Directive which apply to it 合應用指令的規定，則核發 EC 設計檢驗
issue an EC design-examination certificate 證書給申請者。證書需包含檢查結果、適用
to the applicant. The certificate must
contain the conclusions of the examination, 條件，識別核准之設計所需的資料以及如
the conditions for its validity, the necessary 與其有關時，包括壓力設備或附屬設備的
data for identification of the approved
design and, if relevant, a description of the 功能描述；
functioning of the pressure equipment or
accessories;
(d) the applicant must inform the notified body (d) 當 EC 設計檢驗證書所核准的設計有修改
that has issued the EC design-examination
certificate of all modifications to the 時，申請人需通知驗證機構。當所作之修改
approved design. Modifications to the 可能造成不符合指令基本要求時或改變原
approved design must receive additional
approval from the notified body that issued 先的使用條件時，需再實施額外的核准程
the EC design-examination certificate where 序。此額外核准需用附件加到之前的 EC 設
they may affect conformity with the
essential requirements of the Directive or the 計檢驗證書上。
prescribed conditions for use of the pressure
equipment. This additional approval must
be given in the form of an addition to the
original EC design-examination certificate;
(e) each notified body must also communicate (e) 當 EC 設計檢驗證書被撤消或拒用時，該

to the other notified bodies the relevant
information concerning the EC design- 驗證機構需將相關資訊通知其它驗證機構。
examination certificates it has withdrawn or
refused.
2. Final assessment as referred to in section 3.2 of 2. 驗證機構以不預期訪查的方式來執行附件 I

Annex I is subject to increased surveillance in the
form of unexpected visits by the notified body. 第 3.2 節所述之最終評估。訪查時由驗證機構
In the course of such visits, the notified body 主導壓力設備的檢驗。
must conduct examinations on the pressure
equipment.
97/101
ANNEX IV
附件 IV
MINIMUM CRITERIA TO BE MET WHEN DESIGNATING THE NOTIFIED BODIES REFERRED

TO IN ARTICLE 12 AND THE RECOGNIZED THIRD-PARTY ORGANIZATIONS REFERRED TO IN
ARTICLE 13
指定條款 12 所述之驗證機構與條款 13 所述之被認可的第三者組織所需符合的最小準則
1. The body, its director and the personnel 1. 檢查單位或其授權代表的總裁與負責實施評鑑

responsible for carrying out the assessment and
verification operations may not be the designer, 與驗證運作的人，不一定要是壓力設備或組合
manufacturer, supplier, installer or user of the 設備的設計人、製造人、供應者、安裝人或使用
pressure equipment or assemblies which that
body inspects, nor the authorized representative 人。他們並一定要變成直接牽涉到壓力設備的
of any of those parties. They may not become 設計、建構、標示或維修，也不一定要代表公司
directly involved in the design, construction,
marketing or maintenance of the pressure 來參與這些活動。此不可阻止壓力設備或組合
equipment or assemblies, nor represent the parties 設備製造廠與驗證機構之間技術資訊交換的可
engaged in these activities. This does not
preclude the possibility of exchanges of technical 能性。
information between the manufacturer of pressure
equipment or assemblies and the notified body.
2. The body and its personnel must carry out the 2. 這些機構與其人員必須以最高度的專業整合性
assessments and verifications with the highest
degree of professional integrity and technical 與技術競爭力來實施評鑑與驗證。人員必須能
competence and must be free from all pressures 免於所有來自於對驗證結果有興趣的人或一群
and inducements, particularly financial, which
might influence their judgement or the results of 人的施壓與關說，特別是在金錢方面，可能會
the inspection, especially from persons or groups 影響其判斷或檢查結果，
of persons with an interest in the results of
verifications.
3. The body must have at its disposal the necessary 3. 這些機構必須有人員與設施使得有關檢查與監

personnel and possess the necessary facilities to
enable it to perform properly the technical and 督操作的技術與行政任務得以適當執行，同時
administrative tasks connected with the 必須有執行特殊驗證所需的設備。
inspection and surveillance operations, it must
also have access to the equipment required to
perform special verifications.
4. The personnel responsible for inspection must 4. 負責檢查的人必須有：

have:
— sound technical and vocational training, －優良技術與職業訓練，
— satisfactory knowledge of the requirements of －對實施之檢查要求有充分知識與適當的操

the inspections they carry out and adequate
experience of such operations, 作經驗，
98/101
— the ability required to draw up the certificates, －草擬用以展示已實施檢查之證書、記錄與報

records and reports to demonstrate that the
inspections have been carried out. 告所需的能力，
5. The impartiality of the inspection personnel must 5. 檢查員的公平性必須保證。不可用檢查數量或

be guaranteed. Their remuneration must not
depend on the number of inspections carried out, 檢查結果來定檢查員的酬勞。
nor on the results of such inspections.
6. The body must take out liability insurance unless 6. 這些機構必須取得責任保險，除非會員國有根

its liability is assumed by the State in accordance
with national law, or the Member State itself 據國家法律規定其責任，或是會員國本身直接
directly responsible for the inspections. 負責檢查。
7. The personnel of the body must observe 7. 這些機構的人員必須注意到在指令或任何國家

professional secrecy with regard to all
information gained in carrying out their tasks 法律規定下其執行工作時所獲得的資料予以保
(except vis-à-vis the competent administrative 密。
authorities of the State in which their activities
are carried out) under the Directive or any
provision of national law giving effect to it.
99/101
ANNEX V
附件 V
CRITERIA TO BE MET WHEN AUTHORIZING USER INSPECTORATES REFERRED TO IN

ARTICLE 14
指定條款 14 所述之使用者檢查小組所需符合的準則
1. The user inspectorate must be organizationally 1. 使用者檢查小組必須經由有組織的單位來確認

identifiable and have reporting methods within
the group of which it is part which ensure and 和報告產生的方式來進行以確保其公證性，其
demonstrate its impartiality. It must not be 不必對設計製造供應安裝操作和維護壓力設備
responsible for the design, manufacture, supply,
installation, operation or maintenance of the 及組件負責；亦不必參與任何會影響其獨立正
pressure equipment or assemblies, and must not 確判斷檢驗活動。
engage in any activities that might conflict with
its independence of judgement and integrity in
relation to its inspection activities.
2. The user inspectorate and its personnel must 2. 使用者檢查小組和其人員必須以最高度的專業

carry out the assessments and verifications with
highest degree of professional integrity and 整合能性與技術競爭力來實施評鑑與驗證。人
technical competence and must be free from all 員必須能免於所有來自於對驗證結果有興趣的
pressures and inducements, particularly financial,
which might influence their judgement or the 人或一群人的施壓與關說，特別是在金錢方
results of the inspection, especially from persons 面，可能會影錩其介斷或檢查結果。
or groups of persons with an interest in the results
of verifications.
3. The user inspectorate must have at its disposal 3. 使用者檢查小組必須有人員與設施使得有關檢

the necessary personnel and possess the
necessary facilities to enable it to perform 查與監督操作的技術與行政任務得以適當執
properly the technical and administrative tasks 行，同時必須有執行特殊驗證所需的設備。
connected with the inspection and surveillance
operations; it must also have access to the
equipment required to perform special
verifications.
4. The personnel responsible for inspection must 4. 負責檢驗的人員必須有：

have:
— sound technical and vocational training, — 健全的技術及職業訓練。
— satisfactory knowledge of the requirements of — 對實施之檢查要求有充分知識與適當的操

the inspections they carry out and adequate
experience of such operations, 作經驗。
— the ability required to draw up the certificates, — 草擬用以展示已實施檢查之證書、記錄與報

records and reports to demonstrate that the
inspections have been carried out. 告所需的能力。
100/101
5. The impartially of inspection personnel must be 5. 必須保證檢驗員的公正性，不可依據已檢驗的

guaranteed. Their remuneration must not depend
on the number of inspections carried out, nor on 次數及檢驗的結果來決定員工報酬。
the results of such inspections.
6. The user inspectorate must have adequate 6. 使用者檢查小組必須有適當的責任保險除非責

liability insurance unless liability is assumed by
the group of which it is part. 任的承擔是組織的一部分。
7. The personnel of the user inspectorate must 7. 使用者檢查小組的成員必須注意到在指令或任

observe professional secrecy with regard to all
information gained in carrying out their tasks 何國定法律規定下其執行工作時所獲得的資料
(except vis-à-vis the competent administrative 予以保密。
authorities of the State in which their activities
are carried out) under the Directive or any
provision of national law giving effect to it.
101/101
ANNEX VI
附件 VI
CE MARKING
CE 標誌
The CE marking consists of the initials 'CE' taking the following form:
CE 標誌以下列型式之 CE 所組成：
If the CE marking is reduced or enlarged the 假如 CE 標誌必須依上面的圖來比例地縮小或放

proportions given in the above graduated drawing
must be respected. 大。
The various components of the CE marking must CE 標誌每一個字垂直方向的大小要相同且不得小

have substantially the same vertical dimension, which
may not be less than 5 mm. 於 5mm。
102/101
ANNEX VII
附件 VII
DECLARATION OF CONFORMITY
符合聲明書
The EC declaration of conformity must contain the EC 符合聲明書必須包括以下特別事項：

following particulars:
— name and address of the manufacturer or of his －製造廠或其設在共同體內的授權代表的名稱與

Community, 地址，
— description of the pressure equipment or －壓力設備或組合設備的描述，

assembly,
— conformity assessment procedure followed, －所依循的符合性評鑑程序，
— in the case of assemblies, description of the －若是組合設備，對組成組合設備之壓力設備的

pressure equipment constituting the assembly, and
the conformity assessment procedures followed, 描述以及其所遵循的符合性評鑑程序，
— where appropriate, name and address of the －方便的話，實施檢查之驗證機構的名稱與地

notified body which carried out the inspection,
址，
— where appropriate, a reference to the EC type- －方便的話，EC 型式-檢驗證書、EC 設計-檢驗證

examination certificate, EC design-examination
certificate or EC certificate of conformity, 書與 EC 符合證書的參照，
— where appropriate, name and address of the －方便的話，監視製造廠品質保證系統的驗證機

notified body monitoring the manufacturer's
quality assurance system, 構的名稱與地址，
— where appropriate, the references of the －方便的話，所應用之調和標準的參照，

harmonized standards applied,
— where appropriate, other technical standards and －方便的話，其它使用的技術標準與規範，

specifications used,
— where appropriate, the references of the other －方便的話，應用共同體其它指令的參照，

Community Directives applied,
— particulars of the signatory authorized to sign the －簽署對製造廠或其設在共同體內的授權代表合

legally binding declaration for the manufacturer or
his authorized representative established within the 法有效力的聲明。
Community.
103/101
CORRIGENDA
Corrigendum to Directive 97/23/EC of the European

Parliament and of the Council of 29 May 1997 on the
approximation of the laws of the Member States
concerning pressure equipment
(Official Journal of the European

Communities L 181 of 9 July 1997)
On page 7, Article 3, points 1.2 and 2.1
for: '100°C',
read: '100°C'.
On page 11, Article 11 (5), fourth line
for: '…issued for if the type …',
read: '…issued or if the type…'.
104/101

97 23 EC指令 (中英對照)

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97 23 EC指令 (中英對照)

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97/23/EC PED 歐盟壓力設備指令

DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

THE EUROPEAN PARLIAMENT AND THE 歐洲議會與歐盟理事會，

Having regard to the Treaty establishing the 就建立歐洲共同體之條約與其中特別條款 100a，

Having regard to the proposals from the Commission, 就執行委員會(以下簡稱執委會)之提案，

Having regard to the Opinion of the Economic and 參考經濟與社會委員會之意見，

1. Whereas the internal market is an area without 1. 內部市場是指一個沒有內部邊界的區域，可確

2. Whereas there are differences in the content and 2. 各會員國就有關人民與必要時含家畜或財產，

3. Whereas the harmonization of national legislation 3. 要消除這些自由貿易障礙的唯一方法就是調和

4. Whereas equipment subject to a pressure of not 4. 承壓不超過 0.5 bar 的設備將不會因其中之壓力

hazard due to pressure; whereas there should not 造成實質之危險；對這樣的設備沒有必要限制

5. Whereas this Directive relates also to assemblies 5. 本指令同時適用於由幾個不同壓力設備所組成

6. Whereas this Directive harmonizes national 6. 本指令調和各國有關因壓力造成危險的國家規

7. Whereas, for pressure equipment covered by 7. 國際慣例、運輸用與有壓力危險之虞所涵蓋的

8. Whereas certain types of pressure equipment, 8. 某些型式的壓力設備，雖然承受最高容許壓力

order to ensure free movement of such equipment 有必要；結果是它可以刻意地被排除於本指令

9. Whereas other pressure equipment subject to a 9. 對其它承受最高容許壓力大於 0.5 bar 且會因

10. Whereas regulations to remove technical barriers 10. 為 消 除 貿 易 技 術 障 礙 所 訂 之 規 則

11. Whereas the existing Community Directives on 11. 現今與壓力設備有關之會員國近似法律的共同

bilateral recognition of testing and certification of 作上並不令人滿意，因此將被有效的共同體措

13. Whereas the scope of this Directive must be 13. 本指令適用範圍為基於「壓力設備」的一般性

14. Whereas compliance with the essential safety 14. 為確保壓力設備的安全，符合基本安全要求

15. Whereas Member States should be in a position 15. 站在貿易平等的立場，各會員國對尚不符合本

16. Whereas in order to ease the task of 16. 為使遵循基本要求的任務簡單化，調和歐洲各

17. Whereas, for the purposes of this Directive, a 17. 為達到本指令目的，調和標準是在執委會的要

Council Directive 83/189/EEC of 28 March 1983 所提之概要性指導，還需遵照 1983 年 3 月 28

18. Whereas manufacturing of pressure equipment 18. 製造壓力設備需使用安全可靠的材料；對一再

19. Whereas, in view of the nature of the hazards 19. 使用壓力設備會有危險，從危險性這個觀點來

20.Whereas Member States should be in a position to 20. 各會員國應授權使用者檢查小組來實施某些本

and tested by a notified body or a user inspectorate 與測試，此為壓力設備最終評估的一部分；在

22. Whereas pressure equipment will, as a general 22. 一般來說，壓力設備的 CE 標誌是由製造廠或

24.Whereas the addresses of any decision taken under 24. 依本指令所採用之任何決定的受文者，必須被

25. Whereas it is necessary to lay down a transitional 25. 為使強制依照國家規則所製造的壓力設備，在

26. Whereas the requirements laid down in the 26. 在附件內所定之要求，應儘可能清楚制定，讓

27. Whereas an agreement on a modus vivendi 27. 依據條約條款 189b 所定之程序，歐洲議會、理

1. This Directive applies to the design, manufacture 1. 本指令應用於最高容許壓力 PS 大於 0.5 bar 的

2. For the purposes of this Directive: 2. 針對本指令的目的：

2.1 “Pressure equipment” means vessels, piping, 2.1「壓力設備」是指容器、管路、安全附屬設備與

Where applicable, pressure equipment includes 若適用的話，壓力設備包括連接到承壓件之

2.1.1 “Vessel” means a housing designed and built to 2.1.1 「容器」是指經設計與建造的一個內含壓力

2.1.2 “Piping” means piping components intended 2.1.2 「管路」(Piping)是指用來輸送流體的管路元

2.1.3 “Safety accessories” means devices designed 2.1.3 「安全附屬設備」是指當超出設備容許限

－ devices for direct pressure limitation, such as － 直接壓力限裝置，像是安全閥、破裂盤、

－ limiting devices, which either activate the － 限制裝置，可以是啟動修正方法、停機、

2.1.4 “Pressure accessories” means devices with an 2.1.4 「壓力附屬設備」是指一具操作功能且有承

2.1.5 “Assemblies” means several pieces of pressure 2.1.5 「組合設備」是指由製造廠組裝多件壓力設

2.2 “Pressure” means pressure relative to 2.2 「壓力」是指相對於大氣壓之壓力，即錶壓

It is defined at a location specified by the 依製造廠指定之位置來訂定。此點需為保護與/

2.4 “Maximum/minimum allowable temperature TS” 2.4 「最高/最低容許溫度 TS」是指所設計之壓力設

2.5 “Volume (V)” means the internal volume of a 2.5 「容積(V)」是指壓力室的內容積，包括第 1 段

2.6 “Nominal size (DN)” means a numerical 2.6 「公稱尺寸(DN)」是指共通於所有管系元件(不

2.7 “Fluids” means gases, liquids and vapours in 2.7 「流體」是指氣體、液體與飽和汽。流體可包含

2.8 “Permanent joints” means joints which cannot be 2.8 「永久性接頭」是指無法被分開(除非使用破壞

2.9 “European approval for materials” means a 2.9 「歐洲核准材料」是指一份定義材料特性的技

covered by any harmonized standard.

3 The following are excluded from the scope of this 3 下列各項不適用本指令：

3.1 pipelines comprising piping or a system of piping 3.1 由管路或管系所組成之管線(Pipelines)，此管

3.2 networks for the supply, distribution and 3.2 水的供應網、配送網、排放網以及相關的設

3.3 equipment covered by Directive 87/404/EEC on 3.3 87/404/EEC 簡 單 壓 力 容 器 指 令 所 涵 蓋 的 設

3.5 equipment intended for the functioning of 3.5 由下列指令與附件所定義之車用設備：

－ Council Directive 70/156/EEC of 6 February － 1970 年 2 月 6 日理事會 70/156/EEC 指令有

－ Council Directive 74/150/EEC of 4 March － 1974 年 3 月 4 日理事會 74/150/EEC 指令有

10. Whereas regulations to remove technical barriers 10. 為消除貿易技術障礙所訂之規則

－ devices for direct pressure limitation, such as －直接壓力限裝置，像是安全閥、破裂盤、

－ limiting devices, which either activate the －限制裝置，可以是啟動修正方法、停機、

3.3 equipment covered by Directive 87/404/EEC on 3.3 87/404/EEC 簡單壓力容器指令所涵蓋的設

－ Directive 94/9/EC of the European Parliament － 1994 年 3 月 23 日歐洲議會與理事

－ engines including turbines and internal －渦輪引擎與內燃機等引擎，

－ steam engines, gas/ steam turbines, turbo- －蒸汽引擎，氣體 /蒸汽渦輪機，渦輪發電

－ for fluids in Group 2, with a volume －容積大於 1 L 及 PS 與 V 之乘積大於 50

－ for fluids in Group 2 with a DN greater － DN 大於 32 及 PS 與 DN 的乘積大於