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
SIST EN ISO 10993-2:2023
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
SIST EN ISO 10993-2:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-2:2023

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SIST EN ISO 10993-2:2023


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.

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SIST EN ISO 10993-2:2023
EN ISO 10993-2:2022 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 10993-2:2023
EN ISO 10993-2:2022 (E)
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
mo
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