AAMI 10993 12 2012
$93.55
ANSI/AAMI/ISO 10993-12:2012 – Biological evaluation of medical devices-Part 12: Sample preparation and reference materials
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 37 |
Specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993 series. Includes extraction procedures and soluble polymer procedures.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-12:2012, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| 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 |
| 9 | Committee representation |
| 11 | Background of AAMI adoption of ISO 10993-12:2012 |
| 12 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 18 | 4 General requirements 5 Reference materials (RMs) 5.1 General |
| 19 | 5.2 Certification of RMs for biological safety testing 6 Use of RMs as experimental controls 7 Test sample selection |
| 20 | 8 Test sample and RM preparation 9 Selection of representative portions from a device |
| 21 | 10 Preparation of extracts of samples 10.1 General 10.2 Containers for extraction 10.3 Extraction conditions and methods |
| 24 | 10.4 Extraction conditions for hazard identification and risk estimation in the exaggerated-use condition (points to consider in relation to Annex D) |
| 25 | 11 Records |
| 26 | Annex A (informative) Experimental controls |
| 28 | Annex B (informative) General principles on, and practices of, test sample preparation and sample selection |
| 30 | Annex C (informative) Principles of test sample extraction |
| 33 | Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation D.1 General D.2 Selection of appropriate solvents for extracting LMWCs from polymeric devices |
| 34 | D.3 Other points to consider when designing the extraction condition |
| 35 | D.4 Usages of residue obtained by exhaustive extraction in biological evaluation |
| 36 | Bibliography |
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