$62
ISO 10993-13:2010
2010
Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices
- Format:
- Language(s) :
- Published :
- English
- 06/15/2010
ISO 10993-13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.
ISO 10993-13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993-13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers.
ISO 10993-13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.
| ISO 10993-13:2010 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | ISO 10993-13:2010 |
| Scope | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices |
| Publisher | ISO - International Organization for Standardization |
| Languages | English |
| State | |
| Publication Year | 2010 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 810 KB |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Published | 06/15/2010 |
| Same As | ISO 10993-13:2010 |
| ISO 10993-13:2010 | ||
|---|---|---|
| History | Publisher Year | |
| ISO 10993-13:2010 | 2010 | Current |
| ISO 10993-13:1998 | 1998 |
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