oSIST prEN ISO 10993-2:2025
(Main)Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024)
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
Biologische Beurteilung von Medizinprodukten - Teil 2:Tierschutzbestimmungen (ISO/DIS 10993-2:2024)
Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives à la protection des animaux (ISO/DIS 10993-2:2024)
Le présent document spécifie les exigences minimales à satisfaire afin d'assurer et de démontrer que des dispositions appropriées ont été prises pour la protection des animaux utilisés dans le cadre d'expérimentations animales visant à évaluer la biocompatibilité des matériaux utilisés dans des dispositifs médicaux. Il s'adresse aux personnes qui commandent, conçoivent et réalisent des essais ou qui évaluent les données provenant d'expérimentations animales entreprises pour évaluer la biocompatibilité des matériaux destinés à être utilisés dans des dispositifs médicaux, ou des dispositifs médicaux eux-mêmes.
Le présent document donne des recommandations et préconisations visant à réduire davantage à l'avenir le nombre total d'animaux utilisés, à affiner les méthodes d'essai en vue de réduire ou d'éliminer la douleur ou la détresse des animaux, ainsi qu'à remplacer les expérimentations animales par d'autres moyens scientifiquement validées, ne nécessitant pas d'expérimentation animale.
Le présent document est applicable à l'expérimentation animale effectuée sur des vertébrés vivants, à l'exclusion de l'homme, afin d'établir la biocompatibilité des matériaux ou des dispositifs médicaux.
Le présent document n'est pas applicable aux expérimentations effectuées sur des animaux invertébrés et autres formes de vie inférieures ; il ne s'applique pas non plus (sauf en ce qui concerne les dispositions relatives à l'espèce, à l'origine, à l'état de santé, aux soins et à l'hébergement) aux expérimentations réalisées sur des tissus isolés et des organes prélevés à partir d'animaux vertébrés ayant été euthanasiés.
Biološko ovrednotenje medicinskih pripomočkov - 2. del: Zahteve za varstvo živali (ISO/DIS 10993-2:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2025
Biološko ovrednotenje medicinskih pripomočkov - 2. del: Zahteve za varstvo živali
(ISO/DIS 10993-2:2024)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS
10993-2:2024)
Biologische Beurteilung von Medizinprodukten - Teil 2:Tierschutzbestimmungen
(ISO/DIS 10993-2:2024)
Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives à la
protection des animaux (ISO/DIS 10993-2:2024)
Ta slovenski standard je istoveten z: prEN ISO 10993-2
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 10993-2
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 2: 2024-11-11
Animal welfare requirements
Voting terminates on:
2025-02-03
Évaluation biologique des dispositifs médicaux —
Partie 2: Exigences relatives à la protection des animaux
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 10993-2:2024(en)
DRAFT
ISO/DIS 10993-2:2024(en)
International
Standard
ISO/DIS 10993-2
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 2:
Animal welfare requirements
Voting terminates on:
Évaluation biologique des dispositifs médicaux —
Partie 2: Exigences relatives à la protection des animaux
ICS: 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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POTENTIAL TO BECOME STANDARDS TO
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TO SUBMIT, WITH THEIR COMMENTS,
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10993-2:2024(en)
ii
ISO/DIS 10993-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 3
4.1 General .3
4.2 Justification for animal tests .4
4.3 Competence of personnel .5
4.4 Planning and performance of animal tests .5
4.4.1 General .5
4.4.2 Re-use .5
4.5 Test strategy — Sequence of in vitro and in vivo tests .6
4.6 Animal care and accommodation .6
4.6.1 General .6
4.6.2 Restraint .6
4.6.3 Surgical procedures . .6
4.7 Humane end points .7
4.7.1 General .7
4.7.2 Euthanasia .7
4.8 Study documentation . .7
4.9 Validity of test results and mutual acceptance of data .8
Annex A (informative) Rationale for the development of this document . 9
Annex B (informative) Further suggestions for replacing, reducing and refining animal tests .13
Bibliography . 14
iii
ISO/DIS 10993-2:2024(en)
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 to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical
devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 206, Biological and clinical evaluation of medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 10993-2:2022).
The main change is the update of the bibliography entries.
A list of all parts in the ISO 10993 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 10993-2:2024(en)
Introduction
The goal of the ISO 10993 series is the protection of humans in the context of the use of medical devices.
This document supports the goal of the ISO 10993 series by promoting good science through paying proper
regard to maximizing the use of scientifically sound non-animal tests and by ensuring that those animal
tests performed to evaluate the biological properties of materials used in medical devices are conducted
humanely according to recognized ethical and scientific principles.
The application of such humane experimental techniques, including high standards of animal care and
accommodation, both help to ensure the scientific validity of safety testing and enhance the welfare of the
animals used.
v
DRAFT International Standard ISO/DIS 10993-2:2024(en)
Biological evaluation of medical devices —
Part 2:
Animal welfare requirements
1 Scope
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper
provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of
materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate
data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical
devices, or that of the medical devices themselves.
This document makes recommendations and offers guidance intended to facilitate future further reductions
in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in
animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
This document applies to tests performed on living vertebrate animals, other than man, to establish the
biocompatibility of materials or medical devices.
This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other
than with respect to provisions relating to species, source, health status, and care and accommodation) does
it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been
euthanized.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biologic
...
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