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AAMI/ISO 10993-9:1999 (R2014)
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation productsMore info
Provides general principles for the systematic evaluation of biodegradation of medical devices and design and performance of biodegradation studies. 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.
| Author | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2014-09-23 |
| ICS | 11.100.20 : Biological evaluation of medical devices |
| Cross references | ISO 10993-9 (1999-03), IDT |
| Year | 1990 |
| Document history | |
| Country | USA |
| Keyword | ANSI 10993;ANSI/AAMI/ISO 10993;10993;ANSI/AAMI/ISO 10993-9-1999 (R2014) |