ISO 10993-3:2014

DRAFT INTERNATIONAL STANDARD ISO/DIS 10993-3
ISO/TC 194 Secretariat: DIN
Voting begins on Voting terminates on

2011-08-04 2012-01-04
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION


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
[Revision of second edition (ISO 10993-3:2003)]
ICS 11.100.20


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This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
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©  International Organization for Standardization, 2011

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ISO/DIS 10993-3

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ISO/DIS 10993-3
Contents Page
Foreword .v
Introduction.vii
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Requirements for test strategies .3
4.1 General.3
4.2 Additional requirements for carcinogenicity testing.3
4.3 Additional requirements for reproductive toxicity testing.3
5 Genotoxicity tests.
...