AAMI 10993 9 2009 RA 2014
$75.64
ANSI/AAMI/ISO 10993-9:2009/(R)2014 – Biological evaluation of medical devices, Part 9: Framework for identification and quantification of potential degradation products
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 22 |
AAMI/AAMI/ISO 10993-9 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. Considers both non-resorbable and resorbable materials. Not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient’s body directly or indirectly.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-9:2009/(R) 2014, Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| 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 AAMI adoption of ANSI/AAMI/ISO 10993-9:2009 |
| 10 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 Principles for design of degradation studies 4.1 General 4.2 Preliminary considerations |
| 16 | 4.3 Study design 4.4 Characterization of degradation products from medical devices |
| 17 | 5 Study report |
| 18 | Annex A Consideration of the need for degradation studies |
| 20 | Annex B Biodegradation study considerations B.1 General B.2 Description of medical device and/or material |
| 21 | B.3 Assessment of potential and known degradation products B.3.1 Bulk material changes B.3.2 Release of substances from the surface B.3.3 Multicomponent device or device used with other components |
| 22 | Bibliography |
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