EN ISO 10993-3:2014

SLOVENSKI STANDARD
01-januar-2015
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SIST EN ISO 10993-3:2009
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity
and reproductive toxicity (ISO 10993-3:2014)
Biologische Beurteilung von Medizinprodukten - Teil 3: Prüfungen auf Gentoxizität,
Karzinogenität und Reproduktionstoxizität (ISO 10993-3:2014)
Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la
génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO 10993-3:2014)
Ta slovenski standard je istoveten z: EN ISO 10993-3:2014
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 10993-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.100.20 Supersedes EN ISO 10993-3:2009
English Version
Biological evaluation of medical devices - Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity (ISO
10993-3:2014)
Évaluation biologique des dispositifs médicaux - Partie 3: Biologische Beurteilung von Medizinprodukten - Teil 3:
Essais concernant la génotoxicité, la cancérogénicité et la Prüfungen auf Gentoxizität, Karzinogenität und
toxicité sur la reproduction (ISO 10993-3:2014) Reproduktionstoxizität (ISO 10993-3:2014)
This European Standard was approved by CEN on 6 September 2014.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-3:2014 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 .6

Foreword
This document (EN ISO 10993-3:2014) has been prepared by Technical Committee ISO/TC 194 "Biological
and clinical evaluation of medical devices" in collaboration with 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
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 10993-3:2009.
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 EU Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts 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, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10993-3:2014 has been approved by CEN as EN ISO 10993-3:2014 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 Union 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.1 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.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Essential Requirements (ERs) Clause(s)/sub-clause(s) of
Qualifying remarks/Notes
of Directive 93/42/EEC this EN
ER 7.1 is only partly covered by
ISO 10993-3, since the
standard does not provide
requirements on design and
manufacture. However, this
7.1 (First and second indent) 4, 5, 6 and 7
standard provides a means to
evaluate genotoxicity,
carcinogenicity or reproductive
toxicity risks associated with the
materials which are used.
ER 7.2 is not covered by
ISO 10993-3, since the
standard does not provide
requirements on design and
manufacture and does not
oblige to minimize risk.
However, this standard
7.2 4, 5, 6 and 7
provides a means to evaluate
genotoxicity, carcinogenicity or
reproductive toxicity. This
evaluation can be a preliminary
step for risk minimization. Other
forms of toxicity and
flammability are not dealt with in
this standard.
ER 7.5 is not covered by
ISO 10993-3, since the
standard does not provide
7.5 (First paragraph) 4, 5, 6 and 7 requirements on design,
manufacture and packaging
and does not oblige to minimize
risk.
However, this standard
provides a means to evaluate
genotoxicity, carcinogenicity or
reproductive toxicity. This
evaluation can be a preliminary
step for risk minimization. Other
forms of toxicity and
flammability are not dealt with in
this standard.
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
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 Union 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.1 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.1 — Correspondence between this European Standard and Directive 90/385/EEC on active
implantable medical devices
Essential Requirements (ERs) Clause(s)/sub-clause(s) of
Qualifying remarks/Notes
of Directive 90/385/EEC this EN
ER 9 is only partly covered by
, since the
ISO 10993-3
standard does not provide
requirements on design and
manufacture. However, this
9 (First and second indent) 4, 5, 6 and 7 standard provides a means to
assess genotoxicity,
carcinogenicity or reproductive
toxicity used in the manufacture
of medical devices. Other forms
of toxicity are not covered.
General Note: Presumption of conformity depends on also complying with all relevant clauses/subclauses of
ISO 10993-1.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 10993-3
Third edition
2014-10-01
Biological evaluation of medical
devices —
Part 3:
Tests for genotoxicity, carcinogenicity
and reproductive toxicity
Évaluation biologique des dispositifs médicaux —
Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la
toxicité sur la reproduction
Reference number
ISO 10993-3:2014(E)
©
ISO 2014
ISO 10993-3:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 10993-3:2014(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements for test strategies . 2
4.1 General . 2
4.2 Additional requirements for carcinogenicity testing . 3
4.3 Additional requirements for reproductive toxicity testing . 3
5 Genotoxicity tests . 4
5.1 General . 4
5.2 Test strategy . 4
5.3 Sample preparation . 6
6 Carcinogenicity tests . 7
6.1 General . 7
6.2 Evaluation strategy .
...