BSI 17/30344601 DC:2017 Edition
$13.70
BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process
| Published By | Publication Date | Number of Pages |
| BSI | 2017 | 53 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions |
| 13 | 4 General principles applying to biological evaluation of medical devices |
| 17 | 5 Categorization of medical devices 5.1 General 5.2 Categorization by nature of body contact 5.2.1 Non-contacting devices |
| 18 | 5.2.2 Transient-contacting devices 5.2.3 Surface-contacting devices 5.2.4 External communicating devices |
| 19 | 5.2.5 Implant devices 5.3 Categorization by duration of contact |
| 20 | 6 Biocompatibility evaluation process 6.1 Biological risk assessment 6.1.1 Physical and chemical information 6.1.2 General: Gap analysis and selection of biological endpoints for assessment |
| 22 | 6.1.3 Biological testing |
| 26 | 7 Interpretation of biological evaluation data and overall biological safety assessment |
| 28 | Annex A (informative) Endpoints to be addressed in a biological risk assessment |
| 33 | Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process |
| 46 | Annex C (informative) Suggested procedure for literature review |
| 48 | Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
| 50 | Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered |
| 52 | Bibliography |
