EN ISO 10993-2:2006

SLOVENSKI STANDARD
01-september-2006
1DGRPHãþD
SIST EN ISO 10993-2:2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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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.

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.
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
ISO 10993-2:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 10993-2:2006(E)
Contents Page
Foreword. iv
Introduction . vi
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. 4
4.4 Planning and performance of animal tests .4
4.5 Test strategy — Sequence of in vitro and in vivo tests. 5
4.6 Animal care and accommodation . 5
4.7 Humane endpoints. 6
4.8 Study documentation . 7
4.9 Validity of test results and mutual acceptance of data. 7
Annex A (informative) Rationale for the development of this part of ISO 10993. 8
Annex B (informative) Further suggestions for replacing, reducing and refining animal tests . 12
Bibliography . 13

ISO 10993-2:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
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.
ISO 10993-2 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This second edition cancels and replaces the first edition (ISO 10993-2:1992), which has been technically
revised.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
⎯ Part 1: Evaluation and testing
⎯ Part 2: Animal welfare requirements
⎯ Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
⎯ Part 4: Selection of tests for interactions with blood
⎯ Part 5: Tests for in vitro cytotoxicity
⎯ Part 6: Tests for local effects after implantation
⎯ Part 7: Ethylene oxide sterilization residuals
⎯ Part 9: Framework for identification and quantification of potential degradation products
⎯ Part 10: Tests for irritation and delayed-type hypersensitivity
⎯ Part 11: Tests for systemic toxicity
⎯ Part 12: Sample preparation and reference materials
⎯ Part 13: Identification and quantification of degradation products from polymeric medical devices
⎯ Part 14: Identification and quantification of degradation products from ceramics
⎯ Part 15: Identification and quantification of degradation products from metals and alloys
iv © ISO 2006 – All rights reserved

ISO 10993-2:2006(E)
⎯ Part 16: Toxicokinetic study design for degradation products and leachables
⎯ Part 17: Establishment of allowable limits for leachable substances
⎯ Part 18: Chemical characterization of materials
⎯ Part 19: Physico-chemical, morphological and topographical characterization of materials
⎯ Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 10993-2:2006(E)
Introduction
The goal of the ISO 10993 series of International Standards is the protection of humans in the context of the
use of medical devices.
This part of ISO 10993 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.
vi © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 10993-2:2006(E)

Biological evaluation of medical devices —
Part 2:
Animal welfare requirements
1 Scope
This part of ISO 10993 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. 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.
It 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.
It 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 referenced documents are indispensable for the application 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 10993-1:2003, Biological evaluation of medical devices — Part 1: Evaluation and testing
3 Terms and definitions
For the purposes of this document, the definitions given in ISO 10993-1 and the follow
...