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BS EN ISO 10993-2:2022

BS EN ISO 10993-2:2022

$142.49

Biological evaluation of medical devices – Animal welfare requirements

Published By Publication Date Number of Pages
BSI 2022 26
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Annex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
9 Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
11 Annex ZC (informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
16 Foreword
17 Introduction
19 1 ​Scope
2 ​Normative references
3 ​Terms and definitions
21 4 ​Requirements
4.1 ​General
22 4.2 ​Justification for animal tests
23 4.3 ​Competence of personnel
4.4 ​Planning and performance of animal tests
4.4.1 ​General
4.4.2 ​Re-use
24 4.5 ​Test strategy — Sequence of in vitro and in vivo tests
4.6 ​Animal care and accommodation
4.6.1 ​General
4.6.2 ​Restraint
4.6.3 ​Surgical procedures
25 4.7 ​Humane end points
4.7.1 ​General
4.7.2 ​Euthanasia
4.8 ​Study documentation
26 4.9 ​Validity of test results and mutual acceptance of data
27 Annex A (informative) Rationale for the development of this document
31 Annex B (informative) Further suggestions for replacing, reducing and refining animal tests
32 Bibliography

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BS EN ISO 10993-2:2022
$142.49