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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
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 ā€‹Scope
2 ā€‹Normative references
3 ā€‹Terms and definitions
11 4 ā€‹Requirements
4.1 ā€‹General
12 4.2 ā€‹Justification for animal tests
13 4.3 ā€‹Competence of personnel
4.4 ā€‹Planning and performance of animal tests
4.4.1 ā€‹General
4.4.2 ā€‹Re-use
14 4.5 ā€‹Test strategy ā€” Sequence of in vitro and in vivo tests
4.6 ā€‹Animal care and accommodation
4.6.1 ā€‹General
4.6.2 ā€‹Restraint
4.6.3 ā€‹Surgical procedures
15 4.7 ā€‹Humane end points
4.7.1 ā€‹General
4.7.2 ā€‹Euthanasia
4.8 ā€‹Study documentation
16 4.9 ā€‹Validity of test results and mutual acceptance of data
17 Annex A (informative) Rationale for the development of this document
21 Annex B (informative) Further suggestions for replacing, reducing and refining animal tests
22 Bibliography
BS EN ISO 10993-2:2022
$142.49