EN ISO 10993-2:2022

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

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 10993-2:2022)

Dieses Dokument legt die Mindestanforderungen fest, die zu erfüllen sind, um sicherzustellen und nachzuweisen, dass die richtigen Vorkehrungen für das Wohlergehen der Tiere getroffen wurden, die in Tierversuchen zur Bewertung der Bioverträglichkeit von in Medizinprodukten verwendeten Materialen verwendet werden. Es richtet sich an den Personenkreis, der Versuche in Auftrag gibt, sie plant und durchführt oder Daten aus Tierversuchen auswertet, um die Bioverträglichkeit von Materialien, die für die Verwendung in Medizinprodukten vorgesehen sind, oder von Medizinprodukten selbst, zu beurteilen.
In diesem Dokument werden Empfehlungen gegeben und eine Anleitung angeboten, deren Ziel eine zukünftige weitere Verminderung der Gesamtzahl der verwendeten Tiere, eine Verbesserung der Prüfverfahren zur Verringerung oder Ausschaltung von Schmerz oder Leiden bei Tieren, und der Ersatz von Tierversuchen durch andere wissenschaftlich valide Mittel ist, bei denen Tierversuche nicht erforderlich sind.
Dieses Dokument gilt für Versuche an lebenden Wirbeltieren, außer dem Menschen, zur Feststellung der Bioverträglichkeit von Materialien oder Medizinprodukten.
Diese Dokument gilt nicht für Versuche an Wirbellosen und anderen niederen Formen, auch nicht (außer für die Vorkehrungen hinsichtlich Tierart, Bezugsquellen, Gesundheitszustand, Pflege und Unterbringung) für Versuche an isolierten Geweben und Organen, die aus auf humane Weise getöteten Wirbeltieren entnommen wurden.

Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives à la protection des animaux (ISO 10993-2:2022)

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 10993-2:2022)

Ta dokument določa minimalne zahteve, ki jih je treba izpolniti, da se zagotovi in dokaže, da je bilo ustrezno poskrbljeno za varstvo živali, uporabljenih v preskusih za ocenjevanje biološke združljivosti materialov, ki se uporabljajo v medicinskih pripomočkih. Namenjen je naročnikom, načrtovalcem in izvajalcem preskusov ter ocenjevalcem podatkov, pridobljenih iz preskusov na živalih, opravljenih za oceno biološke združljivosti materialov, ki so namenjeni za uporabo v medicinskih pripomočkih, oziroma samih medicinskih pripomočkov.
Ta dokument daje priporočila in smernice za nadaljnje zmanjšanje skupnega števila uporabljenih živalih v prihodnje, izboljšanje preskusnih metod za zmanjšanje oziroma odpravo bolečin ali stresa pri teh živalih ter nadomestitev preskusov na živalih z drugimi znanstveno utemeljeni načini, pri katerih preskusi na živalih niso potrebni.
Ta dokument se uporablja za preskuse, izvedene na živih vretenčarjih (z izjemo človeka), s katerimi se določi biološka združljivost materialov oziroma medicinskih pripomočkov.
Ta dokument se ne uporablja za preskuse, izvedene na nevretenčarjih in drugih nižjih oblikah (razen v zvezi z določbami, ki se navezujejo na vrsto, izvor, zdravstveno stanje ter oskrbo in nastanitev), prav tako se ne uporablja za preskuse, izvedene na izoliranih tkivih in organih, odvzetih evtanaziranim vretenčarjem.

General Information

• Status: Published
• Publication Date: 22-Nov-2022
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Drafting Committee: CEN/TC 206 - Biocompatibility of medical and dental materials and devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Nov-2022
• Completion Date: 23-Nov-2022
• Ref Project: SIST EN ISO 10993-2:2023 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)

Relations

• Replaces: EN ISO 10993-2:2006 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
• Effective Date: 03-Jul-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2023
Nadomešča:
SIST EN ISO 10993-2:2006
Biološko ovrednotenje medicinskih pripomočkov - 2. del: Zahteve za varstvo živali
(ISO 10993-2:2022)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO
10993-2:2022)
Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO
10993-2:2022)
Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives à la
protection des animaux (ISO 10993-2:2022)
Ta slovenski standard je istoveten z: EN ISO 10993-2:2022
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.

EN ISO 10993-2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2022
EUROPÄISCHE NORM
ICS 11.100.20 Supersedes EN ISO 10993-2:2006
English Version
Biological evaluation of medical devices - Part 2: Animal
welfare requirements (ISO 10993-2:2022)
Évaluation biologique des dispositifs médicaux - Partie Biologische Beurteilung von Medizinprodukten - Teil 2:
2: Exigences relatives à la protection des animaux (ISO Tierschutzbestimmungen (ISO 10993-2:2022)
10993-2:2022)
This European Standard was approved by CEN on 30 October 2022.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-2:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10993-2:2022) 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 and clinical evaluation of medical devices” the secretariat of which is held by
DIN.
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 May 2023, and conflicting national standards shall be
withdrawn at the latest by May 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10993-2:2006.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10993-2:2022 has been approved by CEN as EN ISO 10993-2:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 10993-2
Third edition
2022-11
Biological evaluation of medical
devices —
Part 2:
Animal welfare requirements
Évaluation biologique des dispositifs médicaux —
Partie 2: Exigences relatives à la protection des animaux
Reference number
ISO 10993-2:2022(E)
ISO 10993-2:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 10993-2:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 S c op e . 1
2 Nor m at i ve r ef er enc e s . 1
3 Terms and definitions . 1
4 R e qu i r ement s . 3
4.1 General . 3
4.2 J ustification for animal tests . 4
4.3 Competence of personnel . 5
4.4 P lanning and performance of animal tests . 5
4.4.1 General . 5
4 .4 . 2 R e -u s e . 5
4.5 T est strategy — Sequence of in vitro and in vivo tests . 6
4.6 A nimal care and accommodation . 6
4.6.1 General . 6
4 . 6. 2 R e s t r a i nt . 6
4 . 6 . 3 Su r g ic a l pr o c e du r e s . . 6
4.7 H umane end points . 7
4.7.1 G eneral . 7
4 .7. 2 Eut h a n a s i a . 7
4.8 Study documentation . . 7
4.9 V alidity 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 10993-2:2022(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 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, Biocompatibility of medical and dental materials and devices, in accordance
with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 10993-2:2006), which has been
technically revised.
The main changes are as follows:
— laboratory animal veterinarian and their responsibilities and authority have been clarified;
— requirements for trained veterinary care staff have been added;
— ILAR Guide, IACLAM and AAALAC International have been added;
— aseptic methods, monitoring, pharmaceutical grade of chemical usage for surgery have been added.
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 10993-2:2022(E)
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 p
...