TÜRK STANDARDI

TS EN ISO 10993-4
Mart 2010

TS EN ISO 10993-4:2009, TS EN ISO 10993-4/A1:2009 yerine

ICS 11.100.20

Tıbbi cihazların biyolojik değerlendirilmesi - Bölüm 4: Kan ile etkileşim

deneylerinin seçimi
(ISO 10993-4:2009)
Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
(ISO 10993-4:2009)

Évaluation biologique des dispositifs Biologische Beurteilung von

médicaux - Partie 4: Medizinprodukten - Teil 4:
Choix des essais pour les interactions avec Auswahl von Prüfungen zur Wechselwirkung
le sang (ISO mit Blut (ISO
10993-4:2002, Amd 1:2006 inclus) 10993-4:2002, einschließlich Änderung
(ISO 10993-4:2009) 1:2006)
(ISO 10993-4:2009)

TÜRK STANDARDLARI ENSTİTÜSÜ

Necatibey Caddesi No.112 Bakanlıklar/ANKARA
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ICS 11.100.20 TS EN ISO 10993-4 : 2010-03
TÜRK STANDARDI
EN ISO 10993-4:2009
Milli Önsöz

Bu standard, CEN/TC 206 “Biological evaluation of medical devices-Tıbbi cihazların biyolojik

değerlendirmesi” Teknik Komitesi tarafından hazırlanmış, CEN tarafından 28.04.2009 tarihinde
onaylanmış ve Türk Standardları Enstitüsü Teknik Kurulu'nun 02.03.2010 tarihli toplantısında Türk
Standardı olarak kabul edilerek yayımına karar verilmiştir.

Bu standardda kullanılan bazı kelimeler ve/veya ifadeler patent haklarına konu olabilir. Böyle bir
patent hakkının belirlenmesi durumunda TSE sorumlu tutulamaz.

Bu standard yayınlandığında TS EN ISO 10993-4:2009, TS EN ISO 10993-4/A1:2009 standardının

yerini alır.

CEN üyeleri sırasıyla, Almanya, Avusturya, Belçika, Birleşik Krallık, Bulgaristan, Çek Cumhuriyeti,
Danimarka, Estonya, Finlandiya, Fransa, Hırvatistan, Hollanda, İrlanda,İspanya, İsveç, İsviçre, İtalya,
İzlanda, Kıbrıs, Letonya, Litvanya, Lüksemburg, Macaristan, Malta, Norveç, Polonya, Portekiz,
Romanya, Slovakya, Slovenya ve Yunanistan'ın millî standard kuruluşlarıdır.

TS EN ISO 10993-4 : 2010 standardı, EN ISO 10993-4:2009 standardı ile birebir aynı olup, Avrupa Standardizasyon Komitesi 'nin (Avenue
Marnix 17, B-1000 Brussels) izniyle basılmıştır.

Avrupa StandardlarınınTÜRK STANDARDLARININ

herhangi bir şekildeTELiF HAKKI TSE'YE
ve herhangi AiTTiR.
bir yolla tümSTANDARDIN BU NÜSHASININ
kullanım hakları KULLANIM iZNiKomitesi
Avrupa Standardizasyon TSE TARAFINDAN
(CEN/CENELEC) ve
üye ülkelerine aittir.GAZi
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 TS EN ISO 10993-4 : 2010-03

EUROPEAN STANDARD EN ISO 10993-4

NORME EUROPÉENNE
EUROPÄISCHE NORM May 2009

ICS 11.100.20 Supersedes EN ISO 10993-4:2002

English Version

Biological evaluation of medical devices - Part 4: Selection of

tests for interactions with blood (ISO 10993-4:2002, including
Amd 1:2006)

Évaluation biologique des dispositifs médicaux - Partie 4: Biologische Beurteilung von Medizinprodukten - Teil 4:
Choix des essais pour les interactions avec le sang (ISO Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO
10993-4:2002, Amd 1:2006 inclus) 10993-4:2002, einschließlich Änderung 1:2006)

This European Standard was approved by CEN on 28 April 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard 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 Management Centre or to any CEN member.

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

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-4:2009: E
worldwide for CEN national Members.

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 TS EN ISO 10993-4 : 2010-03
EN ISO 10993-4:2009 (E)

Annex ZB
(informative)

Relationship between this European Standard and the Essential Requirements of

EU Directive 90/385/EEC on Active Implantable Medical Devices

This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZB confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZB — Correspondence between this European Standard and Directive 90/385/EEC on active
implantable medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 90/385/EEC

6 Annex I :
9

6 I.9 of Annex I of 90/385/EEC

6.1.10 18 of 86/609/EEC

A.1 I.9 of Annex I of 90/385/EEC

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

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 TS EN ISO 10993-4 : 2010-03
EN ISO 10993-4:2009 (E)

Contents Page

Foreword ..............................................................................................................................................................3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices ........................................................4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .....................5

2 TÜRK STANDARDLARININ TELiF HAKKI TSE'YE AiTTiR. STANDARDIN BU NÜSHASININ KULLANIM iZNi TSE TARAFINDAN
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 TS EN ISO 10993-4 : 2010-03
EN ISO 10993-4:2009 (E)

Foreword
The text of ISO 10993-4:2002, including Amd 1:2006 has been prepared by Technical Committee
ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 10993-4:2009 by Technical Committee CEN/TC 206 “Biological
evaluation of medical devices” the secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 10993-4:2002.

This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.

For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 10993-4:2002, including Amd 1:2006 has been approved by CEN as a EN ISO 10993-4:2009
without any modification.

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 TS EN ISO 10993-4 : 2010-03

INTERNATIONAL ISO
STANDARD 10993-4
Second edition
2002-10-15
AMENDMENT 1
2006-07-15

Biological evaluation of medical

devices —
Part 4:
Selection of tests for interactions with
blood
AMENDMENT 1

Évaluation biologique des dispositifs médicaux —

Partie 4: Choix des essais pour les interactions avec le sang
AMENDEMENT 1

Reference number
ISO 10993-4:2002/Amd.1:2006(E)

TÜRK STANDARDLARININ TELiF HAKKI TSE'YE AiTTiR. STANDARDIN BU NÜSHASININ KULLANIM iZNi TSE TARAFINDAN © ISO 2006
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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

Amendment 1 to ISO 10993-4:2002 was prepared by Technical Committee ISO/TC 194, Biological evaluation
of medical devices.

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 TS EN ISO 10993-4 : 2010-03

TÜRK STANDARDLARININ TELiF HAKKI TSE'YE AiTTiR. STANDARDIN BU NÜSHASININ KULLANIM iZNi TSE TARAFINDAN
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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

Biological evaluation of medical devices —

Part 4:
Selection of tests for interactions with blood

AMENDMENT 1

Page 1, Clause 1

Replace the last paragraph by the following:

“Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of
tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in
general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The
selection and design of test methods should take into consideration device design, materials, clinical utility,
usage environment and risk benefit. This level of specificity can only be covered in vertical standards.”

Pages 2 and 3, Clause 3

Replace the whole clause by the following:

3.1
blood/device interaction
any interaction between blood or any component of blood and a device resulting in effects on the blood, or on
any organ or tissue or on the device

NOTE Such effects may or may not have clinically significant or undesirable consequences. Annex A comprises
informative text that contains further information on these interactions.

3.2
coagulation
phenomenon that results from activation of the clotting factor cascade

NOTE Factors of the coagulation cascade and fibrinolytic systems can be measured following exposure to devices
either in vitro or in vivo.

3.3
complement system
part of the innate immune system consisting of several plasma proteins, including enzymes and cellular
receptors

NOTE Effector molecules produced from complement components are involved in inflammation, phagocytosis and
cell lysis.

3.4
embolization
process whereby a blood clot, or foreign object, is carried in the bloodstream and which may become lodged
and cause obstruction downstream

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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

3.5
ex vivo test system
term applied to a test system that shunts blood directly from a human subject or test animal into a test
chamber located outside the body

NOTE If using an animal model, the blood may be shunted directly back into the animal (recirculating) or collected in
test tubes for evaluation (single pass). In either case, the test chamber is located outside the body.

3.6
haematology
study of blood that includes quantification of cellular and plasma components of the blood

3.7
platelets
anuclear, cellular body that is present in the circulation and which adheres to surfaces and aggregates to form
a haemostatic plug to minimize bleeding

NOTE Platelet testing includes quantification of platelet numbers as well as analysis of their structure and function.
The testing can include analysis of platelet factors, or components on the platelet surface, which are released from
platelets or are adherent to the device surface.

3.8
thrombosis
in-vivo or ex-vivo phenomenon occurring in flowing whole blood involving activation of the coagulation system
and platelets, which results in thrombus formation

3.9
thrombus
coagulated mixture of red cells, aggregated platelets, fibrin and other cellular elements

3.10
thromboembolization
dislodged thrombus which flows downstream and may cause subsequent vascular blockage or occlusion

Page 7, Tables 1 and 2

Replace the tables by the following:

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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

Table 1 — Circulating blood contacting devices or device components and the categories of
appropriate testing – External communicating devices

Test category

Haematology

Complement
Coagulation
Thrombosis

Platelets

system
Device examples

Catheters in place for less than 24 h (e.g. atherectomy devices, guide ×a ×b

wires)
Blood monitors ×a ×b
Blood storage and administration equipment, blood collection × × ×b ×c
devices, extension sets
Catheters in place for more than 24 h (e.g., intravascular ×a ×b ×
endoscopes, intravascular ultrasound, lasers systems, retrograde
coronary perfusion catheters)
Cell savers × × ×b
Devices for absorption of specific substances from blood × × × ×
Donor and therapeutic aphaeresis equipment and cell separation × × × ×
systems
Extracorporeal membrane oxygenators system ×a × ×
Haemodialysis/haemofiltration equipment
Percutaneous circulatory support devices
Leukocyte removal filter × × ×b ×
a As stated in 3.8, thrombosis is an in-vivo or ex-vivo phenomenon. It is recognized that coagulation and platelet responses are
involved in this process. Therefore, it is up to the manufacturer, to decide if specific testing in the coagulation and platelet test categories
are appropriate for their device.
b Haemolysis testing only.
c Only for aphaeresis equipment and related procedures.

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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

Table 2 — Circulating blood contacting devices or device components and the categories of
appropriate testing – Implant devices

Test category

Haematology

Complement
Coagulation
Thrombosis

Platelets

system
Device examples

Annuloplasty rings, mechanical heart valves ×a ×b

intra-aortic balloon pumps ×a ×
total artificial hearts, ventricular-assist devices ×a × ×
Embolization devices ×a ×b
Endovascular grafts ×a ×b ×
Implantable defibrillators and cardioverters ×a ×b
Pacemaker leads ×a ×b
Prosthetic (synthetic) vascular grafts and patches, including ×a ×b ×
arteriovenous shunts
Stents ×a ×b
Tissue heart valves ×a ×b
Tissue vascular grafts and patches, including arteriovenous shunts ×a ×b
Vena cava filters ×a ×b
a As stated in 3.8, thrombosis is an in-vivo or ex-vivo phenomenon. It is recognized that coagulation and platelet responses are
involved in this process. Therefore, it is up to the manufacturer to decide if specific testing in the coagulation and platelet test categories
are appropriate for their device.
b Haemolysis testing only.

Page 8, subclause 6.1.7

Delete the whole clause and renumber the 6.1.8 to 6.1.14 as 6.1.7 to 6.1.13.

New subclause 6.1.7

Replace the whole clause by the following:

“The recommendations in 6.1.5 and 6.1.6, together with Clause 5, Figure 1 and Table 2 serve as a guide for
the selection of tests listed in 6.2.1. Guidance on pre-clinical evaluations is given in Annex A. The following
procedure shall be performed:

a) determine which of the 5 potential blood interaction categories are appropriate to the device;

b) evaluate existing information on reactions within these categories;

c) select appropriate tests from Table 3 or 4.”

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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

Page 17, Annex B.2

Insert a new subclause B.2.1 as follows:

B.2.1 General

Characterization of thrombosis includes in vitro, ex vivo and in vivo methods, in the appropriate circulation
model(s), animal model(s), or the clinical settings.

Page 18 subclauses (former) B.2.2, B.2.3 and B.2.5

Change reference B.2.1 to B.2.2

subclause (former) B.2.6

Change reference B.2.4 to B.2.5

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 TS EN ISO 10993-4 : 2010-03
ISO 10993-4:2002/Amd.1:2006(E)

ICS 11.100.20
Price based on 5 pages

© ISO 2006 – All rights reserved

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 TS EN ISO 10993-4 : 2010-03
EN ISO 10993-4:2009 (E)

Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of

EU Directive 93/42/EEC on Medical Devices

This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC

6 Annex I:
7.1, 7.2, 7.5

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

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