AAMI 10993 2 2006 RA 2014
$75.64
ANSI/AAMI/ISO 10993-2-2006/(R)2014 – Biological evaluation of medical devices-Part 2: Animal welfare requirements
| Published By | Publication Date | Number of Pages |
| AAMI | 2006 | 29 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-2:2006/(R) 2014, Biological evaluation of medical devices–Part 2: Animal welfare requirements |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 10993-2:2006 |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 15 | 4 Requirements 4.1 General |
| 17 | 4.2 Justification for animal tests 4.3 Competence of personnel |
| 18 | 4.4 Planning and performance of animal tests 4.4.1 General 4.4.2 Re-use |
| 19 | 4.6 Animal care and accommodation 4.6.1 General 4.6.2 Restraint 4.6.3 Surgical procedures 4.7 Humane endpoints 4.7.1 General |
| 20 | 4.7.2 Euthanasia 4.8 Study documentation |
| 21 | 4.9 Validity of test results and mutual acceptance of data |
| 22 | Annex A Rationale for the development of this part of ISO 10993 A.1 General A.2 Principles of humane animal care and use A.3 Replacement |
| 23 | A.4 Reduction A.5 Refinement |
| 24 | A.6 Humane endpoints A.7 Animal accommodation A.7.1 Accommodation and care |
| 25 | A.7.2 Environmental conditions A.8 Ethical review |
| 26 | Annex B Further suggestions for replacing, reducing, and refining animal tests B.1 General B.2 Alternative methods B.3 Data-sharing for prevention of unnecessary duplication B.4 Databases B.5 Minimization of animal usage |
| 27 | B.6 Publication |
| 28 | Bibliography |
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