BS EN ISO 10993-2:2022
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Biological evaluation of medical devices – Animal welfare requirements
| Published By | Publication Date | Number of Pages |
| BSI | 2022 | 26 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 11 | 4 Requirements 4.1 General |
| 12 | 4.2 Justification for animal tests |
| 13 | 4.3 Competence of personnel 4.4 Planning and performance of animal tests 4.4.1 General 4.4.2 Re-use |
| 14 | 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 |
| 15 | 4.7 Humane end points 4.7.1 General 4.7.2 Euthanasia 4.8 Study documentation |
| 16 | 4.9 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 |
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