$74
AAMI/ISO 10993-9:2009/(R)2014
2010
Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
- Format:
- Language(s) :
- Published :
- English
- 08/17/2010
ANSI/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.
| AAMI/ISO 10993-9:2009/(R)2014 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI/ISO 10993-9:2009/(R)2014 |
| Scope | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
| Languages | English |
| State | |
| Publication Year | 2010 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| ANSI | ANSI Approved |
| File Size | 1 file , 300 KB |
| ISBN(s) | 1570203849 |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 22 |
| Published | 08/17/2010 |
| Same As | AAMI/ISO 10993-9:2009/(R)2014 |
| AAMI/ISO 10993-9:2009/(R)2014 | ||
|---|---|---|
| History | Publisher Year | |
| AAMI/ISO 10993-9:2009/(R)2014 | 2010 | Current |
| AAMI/ISO 10993-9:1999/(R2005) | 2000 |
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