BS EN ISO 10993-12:2012
$167.15
Biological evaluation of medical devices – Sample preparation and reference materials
| Published By | Publication Date | Number of Pages |
| BSI | 2012 | 34 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 8 | Foreword |
| 9 | Introduction |
| 11 | 1 Scope 2 Normative references 3 Terms and definitions |
| 13 | 4 General requirements |
| 14 | 5 Reference materials (RMs) 5.1 General 5.2 Certification of RMs for biological safety testing 6 Use of RMs as experimental controls |
| 15 | 7 Test sample selection 8 Test sample and RM preparation 9 Selection of representative portions from a device |
| 16 | 10 Preparation of extracts of samples 10.1 General 10.2 Containers for extraction 10.3 Extraction conditions and methods |
| 19 | 10.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use condition (points to consider in relation to Annex D) 11 Records |
| 20 | Annex A (informative) Experimental controls |
| 22 | Annex B (informative) General principles on, and practices of, |
| 24 | Annex C (informative) Principles of test sample extraction |
| 27 | Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation |
| 29 | Bibliography |
Related products
-
AAMI TIR37137 2014
ANSI/AAMI/ISO TIR37137:2014 – Cardiovascular biological evaluation of medical devices-Guidance for absorbable implants Published By Publication…
