EN ISO 10993-2:2006

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)

ISO 10993-2:2006 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 of the medical devices themselves. It 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.
ISO 10993-2:2006 also 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.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:2006)

Dieser Teil von ISO 10993 ist für den Personenkreis gedacht, der Versuche in Auftrag gibt, sie plant und durchführt oder Daten aus Tierversuchen auswertet, um die Bioverträglichkeit von Materialien, die in Medizinprodukten verwendet werden sollen oder von Medizinprodukten selbst, zu bewerten. Er legt die Mindestanforderungen fest, die erfüllt werden müssen, um sicherzustellen und nachzuweisen, dass für den Schutz der Tiere, die in Versuchen zur Bewertung der Bioverträglichkeit von in Medizinprodukten zu verwendenden Materialien verwendet werden, die richtigen Vorkehrungen getroffen wurden.
In ihm werden auch Empfehlungen gemacht 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.
Er gilt für Versuche an lebenden Wirbeltieren, außer dem Menschen, zur Feststellung der Bioverträglichkeit von Materialien oder Medizinprodukten.
Er gilt nicht für Versuche an Wirbellosen und anderen niedrigeren Formen des Lebens, 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 10993-2:2006)

L'ISO 10993-2:2006 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. Elle spécifie les exigences minimales à satisfaire afin de garantir et de démontrer que des dispositions appropriées ont été prises concernant la protection des animaux utilisés dans les expérimentations animales à des fins d'évaluation de la biocompatibilité de matériaux utilisés dans les dispositifs médicaux.
L'ISO 10993-2:2006 donne également des recommandations et propose des directives visant à réduire dans l'avenir le nombre total d'animaux utilisés, l'affinement des méthodes d'essai en vue de minimiser ou éliminer la douleur ou la détresse des animaux, ainsi que le remplacement des expérimentations animales par d'autres moyens scientifiquement valables ne nécessitant pas l'expérimentation sur les animaux.
Elle 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.

Biološko ovrednotenje medicinskih pripomočkov – 2. del: Zahteve za varstvo živali (ISO 10993-2:2006)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2006
• Withdrawal Date: 22-Nov-2022
• ICS: 11.100 - Laboratory medicine
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 23-Nov-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10993-2:2006 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)

Relations

• Replaces: EN ISO 10993-2:1998 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:1992)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10993-2:2022 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
• Effective Date: 03-Jul-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-2:2006
01-september-2006
1DGRPHãþD
SIST EN ISO 10993-2:2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRY±GHO=DKWHYH]DYDUVWYRåLYDOL
,62
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO
10993-2:2006)
Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO
10993-2:2006)
Évaluation biologique des dispositifs médicaux - Partie 2: Exigences relatives a la
protection des animaux (ISO 10993-2:2006)
Ta slovenski standard je istoveten z: EN ISO 10993-2:2006
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-2:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-2:2006

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SIST EN ISO 10993-2:2006


EUROPEAN STANDARD
EN ISO 10993-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2006
ICS 11.100.20 Supersedes EN ISO 10993-2:1998
English Version
Biological evaluation of medical devices - Part 2: Animal welfare
requirements (ISO 10993-2:2006)
Évaluation biologique des dispositifs médicaux - Partie 2: Biologische Beurteilung von Medizinprodukten - Teil 2:
Exigences relatives à la protection des animaux (ISO Tierschutzbestimmungen (ISO 10993-2:2006)
10993-2:2006)
This European Standard was approved by CEN on 14 July 2006.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10993-2:2006: E
worldwide for CEN national Members.

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SIST EN ISO 10993-2:2006

EN ISO 10993-2:2006 (E)





Foreword


This document (EN ISO 10993-2:2006) has been prepared by Technical Committee ISO/TC 194
"Biological evaluation of medical devices" in collaboration with Technical Committee CEN/TC
206 "Biocompatibility of medical and dental materials and devices", the secretariat of which is
held by NEN.

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 January 2007, and conflicting national
standards shall be withdrawn at the latest by January 2007.

This document supersedes EN ISO 10993-2:1998.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 10993-2:2006 has been approved by CEN as EN ISO 10993-2:2006 without any
modifications.

2

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SIST EN ISO 10993-2:2006

INTERNATIONAL ISO
STANDARD 10993-2
Second edition
2006-07-15


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 10993-2:2006(E)
©
ISO 2006

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SIST EN ISO 10993-2:2006
ISO 10993-2:2006(E)
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