SIST EN ISO 10993-2:2000

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:1992)

This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended: a) to establish guidelines which allow the scientist to respect life in general; b) to reduce the number of animal experiments and the number of animals used in experiments and the number of animals used in experiments, among other ways, by optimization of those performed; c) to improve the quality of life of the animals used in the experiments.

Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:1992)

Dieser Teil der ISO 10993 legt die Mindestanforderungen beim Einsatz von Tieren in der biologischen Prüfung fest. Dieser Teil der ISO 10993 hat außerdem zum Ziel: a) Richtlinien aufzustellen, die es dem Wissenschaftler erlauben, Leben im allgemeinen zu achten; b) eine Verminderung der Anzahl der Tierversuche und der Zahl der verwendeten Tiere herbeizuführen, unter anderem durch Optimieren der durchgeführten Untersuchungen; c) das Leiden der Versuchstiere auf ein Minimum zu reduzieren und die Lebensqualität der Versuchstiere zu erhalten.

Evaluation biologique des dispositifs médicaux - Partie 2: Exigences concernant la protection des animaux (ISO 10993-2:1992)

La présente partie de l'ISO 10993 détermine un minimum de prescriptions lors de l'utilisation d'animaux a des fins d'évaluation biologique. Cette partie de l'ISO 10993 est aussi destinée: a) a établir des guides qui assignent aux scientifiques a respecter la vie en général; b) a réduire le nombre d'expérimentations sur animal et le nombre d'animaux utilisés dans les expériences, avec entre autre but, celui d'optimiser les résultats obtenus par l'animal; c) a améliorer la qualité de la vie de ces animaux d'expérience.

Biološko ovrednotenje medicinskih pripomočkov - 2. del: Zahteve za varstvo živali (ISO 10993-2:1992)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 31-Aug-2006
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Sep-2006
• Due Date: 01-Sep-2006
• Completion Date: 01-Sep-2006
• 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: EN ISO 10993-2:1998 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:1992)

Relations

• Replaced By: SIST EN ISO 10993-2:2006 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
• Effective Date: 01-Sep-2006

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10993-2:2000
01-januar-2000
%LRORãNRRYUHGQRWHQMHPHGLFLQVNLKSULSRPRþNRYGHO=DKWHYH]DYDUVWYRåLYDOL
,62
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO
10993-2:1992)
Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO
10993-2:1992)
Evaluation biologique des dispositifs médicaux - Partie 2: Exigences concernant la
protection des animaux (ISO 10993-2:1992)
Ta slovenski standard je istoveten z: EN ISO 10993-2:1998
ICS:
11.100.20 %LRORãNRRYUHGQRWHQMH Biological evaluation of
PHGLFLQVNLKSULSRPRþNRY medical devices
SIST EN ISO 10993-2:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10993-2:2000

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SIST EN ISO 10993-2:2000

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SIST EN ISO 10993-2:2000

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SIST EN ISO 10993-2:2000

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SIST EN ISO 10993-2:2000

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SIST EN ISO 10993-2:2000
INTERNATIONAL
IS0
STANDARD
10993-2
First edition
1992-l 2-l 5
Biological evaluation of medical devices -
Part 2:
Animal welfare requirements
halua tion biologique des dispositifs m6dicaux -
Partie 2: Exigences concernant la protection des animaux
Reference number
IS0 10993-2:1992(E)

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SIST EN ISO 10993-2:2000
IS0 10993=2:1992(E)
Contents
Page
1
..............................................................................................
1 Scope
1
.......................................................................
2 Normative reference
I
.......................................................................................
3 Definitions
2
............................................................................
4 Requirements
3
....................................................................
5 Recommendations
Annex
5
. . . . . . . . . . . . . . . . . . . . . . . . .~.~.~.
A Bibliography
0 IS0 1992
Ail rights reserved. No part of this publication may be reproduced or utilized in any form or
by any means, electronic or mechanical, including photocopying and microfilm, without per-
mission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-I 211 Geneve 20 l Switzerland
Printed in Switzerland
ii

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SIST EN ISO 10993-2:2000
IS0 10993=2:1992(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be re-
presented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 10993-2 was prepared by Technical Committee
lSO/TC 194, Biological evaluation of medical devices.
IS0 10993 consists of the following parts, under the general title Biological
evaluation of medical devices:
- Part I: Guidance on selection of tests
- Part 2: Animal welfare requirements
- Part 3: Tests for geno toxicity, carcinogenicity and reproductive
toxicity
- Part 4: Selection of tests for interactions with blood
- Part 5: Tests for cytotoxicity: in vitro methods
- Part 6: Tests for local effects after implantation
- Part 7: Ethylene oxide sterilization residuals
- Part 8: Clinical investigation
- Part 9: Degradation of materials related to biological testing
- Part IO: Tests for irritation and sensitization
- Part 11: Tests for systemic toxicity
- Part 12: Sample preparation and reference materials
Future parts will deal with other relevant aspects of biological testing.
Annex A of this part of IS0 10993 is for information only.

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SIST EN ISO 10993-2:2000
IS0 10993=2:1992(E)
Introduction
The protection of humans is the primary goal of the IS0 10993 series of
standards. A second equally important goal is to ensure animal welfare and
to minimize the number and exposure of the laboratory animals.
This part of IS0 10993 was developed to ensure the welfare of animals
used in biological evaluation testing. Therefore, minimum requirements for
the care and use of animals are stated.
A list of international documents concerning the care and handling of ani-
mals in biomedical research is given in annex A for information.

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SIST EN ISO 10993-2:2000
IS0 10993=2:1992(E)
INTERNATIONAL STANDARD
Biological evaluation of medical devices -
Part 2:
Animal welfare requirements
of this part of IS0 10993. At the time of publication,
1 Scope
the edition indicated was valid. All standards are sub-
ject to revision, and parties to agreements based on
This part of IS0 10993 specifies minimum require-
this part of IS0 10993 are encouraged to investigate
ments for the use of animals in biological testing.
the possibility of applying the most recent edition of
the standard indicated below. Members of IEC and
This part of IS0 10993 is also intended
IS0 maintain registers of currently valid International
Standards.
a) to establish guidelines which allow the scientist to
respect life in general;
IS0 10993-I : 1992, Biological evaluation of medical
devices - Part 7: Guidance on selection of tests.
b) to reduce the number of animal experiments and
the number of animals used in experiments,
among other ways by optimization of those per-
3 Definitions
formed;
For the purposes of this part of IS0 10993, the defi-
c) to minimize suffering and maintain the quality of
nitions given in IS0 10993-I and the following defi-
life of the animals used in the experiments.
nitions apply.
This part of IS0 10993 applies to the experimentation
3.1 animal: Any live non-human vertebrate, exclud-
performed on vertebrates. It does not apply to exper-
ing foetal or embryonic forms, unless otherwise qual-
imentation performed on less differentiated animals;
ified.
nor does it apply to that part of the experimental work
performed on isolated tissues and organs.
3.2 experimental animal: Animal used or to be
This part of IS0 10993 also makes recommendations
used in experiments.
concerned with the aim of reducing the number of
animals used for biocompatibility testing and when
3.3 bred animal: Animal specially bred for use in
possible abolishing animal experiments in this area.
experiments in facilities accredited by, or registered
with, the competent authority.
2 Normative reference 3.4 animal experiment: Any use of an animal for
scientific purposes which may cause it pain, anxiety,
suffering, distress or lasting harm, excluding the least
The following standard contains provisions which,
painful methods accepted in modern veterinary or
through reference in this text, constitute provisions
1

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SIST EN ISO 10993-2:2000
IS0 10993=2:1992(E)
laboratory practice (i.e. “humane” methods) of killing Licensing authorities are to be encouraged to estab-
or marking an animal. lish specific lines of communication directed toward
preventing unnecessary repetition. (See 5.2.)
An experiment starts when an animal is first prepared
for use and ends when no further observations are to
be made for that experiment.
4.3 Availability of results
NOTE 1 The prevention, elimination and minimization of
pain, suffering, distress or lasting harm by the successful
It is strongly recommended that the results of appro-
use of anaesthesia or analgesia or other methods does not
priately performed and evaluated tests be accepted
place the use of an animal outside the scope of this defi-
by all countries.
nition.
3.5 competent auth
...