I.S. EN ISO 10993-2:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS (ISO 10993-2:2006)
Hardcopy , PDF
14-06-2023
English
01-01-2006
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Justification for animal tests
4.3 Competence of personnel
4.4 Planning and performance of animal tests
4.5 Test strategy - Sequence of in vitro and in vivo tests
4.6 Animal care and accommodation
4.7 Humane endpoints
4.8 Study documentation
4.9 Validity of test results and mutual acceptance of data
Annex A (informative) Rationale for the development of this
part of ISO 10993
Annex B (informative) Further suggestions for replacing,
reducing and refining animal tests
Bibliography
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