EN ISO 10993-4:2009

SLOVENSKI STANDARD
01-september-2009
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SIST EN ISO 10993-4:2003/A1:2006
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with
blood (ISO 10993-4:2002, including Amd 1:2006)
Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur
Wechselwirkung mit Blut (ISO 10993-4:2002, einschließlich Änderung 1:2006)
Évaluation biologique des dispositifs médicaux - Partie 4 : Choix des essais concernant
les interactions avec le sang (ISO 10993-4:2002, Amd 1:2006 inclus)
Ta slovenski standard je istoveten z: EN ISO 10993-4:2009
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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
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.
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
Annex I :
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.
INTERNATIONAL ISO
STANDARD 10993-4
Second edition
2002-10-15
Biological evaluation of medical devices —
Part 4:
Selection of tests for interactions with
blood
Évaluation biologique des dispositifs médicaux —
Partie 4: Choix des essais concernant les interactions avec le sang

Reference number
ISO 10993-4:2002(E)
©
ISO 2002
ISO 10993-4:2002(E)
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ISO 10993-4:2002(E)
Contents Page
Foreword . iv
Introduction. vi
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Abbreviated terms. 2
5 Types of device in contact with blood (as categorized in ISO 10993-1). 3
5.1 Non-contact devices. 3
5.2 External communicating devices. 3
5.3 Implant devices. 4
6 Characterization of blood interactions . 5
6.1 General requirements. 5
6.2 Categories of tests and blood interactions . 8
6.3 Types of test . 11
Annex A (informative) Preclinical evaluation of cardiovascular devices and prostheses. 13
Annex B (informative) Laboratory tests — Principles, scientific basis and interpretation. 17
Annex C (informative) Evaluation of haemolytic properties of medical devices and their components . 23
Bibliography. 30

ISO 10993-4:2002(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 3.
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 part of ISO 10993 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-4 was prepared by Technical
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