ISO 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Évaluation biologique des dispositifs médicaux — Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction

L'ISO 10993-3:2014 spécifie les stratégies pour l'estimation des risques, le choix des essais d'identification des risques et la gestion des risques, en fonction du risque d'apparition des effets biologiques potentiellement irréversibles suivants résultant de l'exposition à des dispositifs médicaux: génotoxicité; cancérogénicité; toxicité sur la reproduction et le développement. L'ISO 10993-3:2014 est applicable lorsque le besoin d'évaluer un dispositif médical dont le risque de génotoxicité, de cancérogénicité ou de toxicité sur la reproduction a été identifié.

General Information

• Status: Published
• Publication Date: 23-Sep-2014
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: ISO/TC 194 - Biological and clinical evaluation of medical devices
• Drafting Committee: ISO/TC 194/WG 6 - Mutagenicity, carcinogenicity and reproductive toxicity
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 27-Oct-2023

Relations

• Revises: ISO 10993-3:2003 - Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• Effective Date: 14-Nov-2009

Standards Content (Sample)

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


ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
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.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



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REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
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©  International Organization for Standardization, 2011

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ISO/DIS 10993-3

Copyright notice
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ii © ISO 2011 – All rights reserved

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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.
...

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

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ISO 10993-3:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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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 . 7
6.3 Sample preparation . 8
6.4 Test methods . 8
7 Reproductive and developmental toxicity tests .
...

NORME ISO
INTERNATIONALE 10993-3
Troisième édition
2014-10-01
Évaluation biologique des dispositifs
médicaux —
Partie 3:
Essais concernant la génotoxicité, la
cancérogénicité et la toxicité sur la
reproduction
Biological evaluation of medical devices —
Part 3: Tests for genotoxicity, carcinogenicity and reproductive
toxicity
Numéro de référence
ISO 10993-3:2014(F)
©
ISO 2014

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ISO 10993-3:2014(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
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l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
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Web www.iso.org
Publié en Suisse
ii © ISO 2014 – Tous droits réservés

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ISO 10993-3:2014(F)

Sommaire Page
Avant-propos .iv
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Exigences applicables aux stratégies d’essais. 2
4.1 Généralités . 2
4.2 Exigences supplémentaires applicables aux essais de cancérogénicité . 3
4.3 Exigences supplémentaires applicables aux essais de toxicité sur la reproduction . 4
5 Essais de génotoxicité . 4
5.1 Généralités . 4
5.2 Stratégie d’essai. 4
5.3 Préparation des échantillons . 7
6 Essais de cancérogénicité . 7
6.1 Généralités . 7
6.2 Stratégie d’évaluation. 8
6.3 Préparation des échantillons . 9
6.4 Méthodes d’essai . 9
7 Essais concernant la toxicité sur la reproduction et le développement .10
7.1 Généralités .
...