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СРПСКИ SRPS EN 60601-2-2

СТАНДАРД Март 2011.

Измена 11

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Новембар 2012.
Идентичан са EN 60601-2-2:2009/A11:2011

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Електромедицински уређаји —
Део 2-2: Посебни захтеви за основну
безбедност и битне перформансе
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високофреквенцијских хируршких ножева
и високофреквенцијског хируршког
прибора —
Измена 11
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Medical electrical equipment —

Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high frequency
surgical accessories —
Аmendment 11
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I издање

Референтна ознака
SRPS EN 60601-2-2:2011/A11:2012 (en)
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АУТОРСКА ПРАВА ЗАШТИЋЕНА

Ауторска права за српске стандарде и сродне документе припадају Институту за стандардизацију Србије.
Умножавање, у целини или делимично, као и дистрибуција српских стандарда и сродних докумената,
дозвољени су само уз сагласност Института за стандардизацију Србије.

© ИСС
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Издаје Институт за стандардизацију Србије

ИНСТИТУТ ЗА СТАНДАРДИЗАЦИЈУ СРБИЈЕ

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© ИСС 2012 SRPS EN 60601-2-2:2011/A11:2012

Ову измену донео је директор Института за стандардизацију Србије решењем бр. 3322/69-51-02/2012 од
29. новембра 2012. године.

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Саопштење о проглашавању

Измена европског стандарда EN 60601-2-2:2009/A11:2011, Medical electrical equipment — Part 2-2:

Particular requirements for the basic safety and essential performance of high frequency surgical equipment
and high frequency surgical accessories, прихвата се без икаквих модификација као измена српског
стандарда SRPS EN 60601-2-2:2011/A11 на енглеском језику. Измена европског стандарда може се
набавити у Институту за стандардизацију Србије.

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ICS 11.040.30 Класификациона група N.S5

Дескриптори: медицински, безбедност, високофреквенцијски, хируршки
Descriptors: medical, safety, high frequency, surgical
Укупно страна 3
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EUROPEAN STANDARD EN 60601-2-2/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM October 2011

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ICS 11.040.30

English version

Medical electrical equipment -

Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high frequency

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surgical accessories

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Appareils électromédicaux -
Partie 2-2: Exigences particulières pour la
Medizinische elektrische Geräte -
Teil 2-2: Besondere Festlegungen für die
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sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils Leistungsmerkmale von Hochfrequenz-
d'électrochirurgie à courant haute Chirurgiegeräten und HF-chirurgischem
fréquence et des accessoires Zubehör
d'électrochirurgie à courant haute
fréquence

This amendment A11 modifies the European Standard EN 60601-2-2:2009; it was approved by CENELEC on
2011-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
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stipulate the conditions for giving this amendment the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language
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made by translation under the responsibility of a CENELEC member into its own language and notified to the
CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
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CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-2:2009/A11:2011 E

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EN 60601-2-2:2009/A11:2011 -2-

Foreword
This document (EN 60601-2-2:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in

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medical practice”.

The following dates are fixed:

• latest date by which this document has (dop) 2012-10-01

to be implemented at national level by
publication of an identical national
standard or by endorsement

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latest date by which the national (dow) 2014-10-01
standards conflicting with this
document have to be withdrawn

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Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
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rights.
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-3- EN 60601-2-2:2009/A11:2011

Replace Annex ZZ of EN 60601-2-2:2009 by:

Annex ZZ
(informative)

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Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC except as follows:

– Essential Requirement 6a
– Essential Requirement 7.4

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– Essential Requirement 7.5 paragraph 2 & 3
– Essential Requirement 13.6 (q)
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.

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WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
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