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ISO 10993-16:2017

(Main)

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Évaluation biologique des dispositifs médicaux — Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables

ISO 10993-16:2017 énonce les principes de conception et de mise en ?uvre des études toxicocinétiques relatives aux dispositifs médicaux. L'Annexe A décrit les considérations relatives à l'inclusion d'études toxicocinétiques dans l'évaluation biologique des dispositifs médicaux.

General Information

Status
Published
Publication Date
15-May-2017
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 13 - Toxicokinetics
Current Stage
Ref Project

Relations

Revises
ISO 10993-16:2010 - Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Effective Date
20-Jul-2013

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INTERNATIONAL ISO
STANDARD 10993-16
Third edition
2017-05
Biological evaluation of medical
devices —
Part 16:
Toxicokinetic study design for
degradation products and leachables
Évaluation biologique des dispositifs médicaux —
Partie 16: Conception des études toxicocinétiques des produits de
dégradation et des substances relargables
Reference number
ISO 10993-16:2017(E)
©
ISO 2017

---------------------- Page: 1 ----------------------
ISO 10993-16:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 10993-16:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles for design of toxicokinetic studies . 3
5 Guidance on test methods . 3
5.1 General considerations . 3
5.2 Guidance on specific types of test . 5
5.2.1 General. 5
5.2.2 Absorption . 5
5.2.3 Distribution . 5
5.2.4 Metabolism and excretion . 6
Annex A (normative) Circumstances in which toxicokinetic studies shall be considered .7
Bibliography . 9
© ISO 2017 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 10993-16:2017(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.
The procedures used
...

NORME ISO
INTERNATIONALE 10993-16
Troisième édition
2017-05
Évaluation biologique des dispositifs
médicaux —
Partie 16:
Conception des études
toxicocinétiques des produits de
dégradation et des substances
relargables
Biological evaluation of medical devices —
Part 16: Toxicokinetic study design for degradation products and
leachables
Numéro de référence
ISO 10993-16:2017(F)
©
ISO 2017

---------------------- Page: 1 ----------------------
ISO 10993-16:2017(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2017, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 10993-16:2017(F)

Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Principes de conception des études toxicocinétiques . 3
5 Directives relatives aux méthodes d’essai . 4
5.1 Considérations générales . 4
5.2 Directives concernant les types d’essais spécifiques . 5
5.2.1 Généralités . 5
5.2.2 Absorption . 6
5.2.3 Distribution . 6
5.2.4 Métabolisme et excrétion . 6
Annexe A (normative) Circonstances nécessitant d’envisager des études toxicocinétiques .8
Bibliographie .10
© ISO 2017 – Tous droits réservés iii

---------------------- Page: 3 ----------------------
ISO 10993-16:2017(F)

Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles d
...

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