$136
AAMI/ISO 10993-7:2008/(R)2012
2007
Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)
- Format:
- Language(s) :
- Published :
- English
- 12/10/2007
Includes a January 2010 erratum at the end.
AAMI/ISO 10993-7 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released.
Additional background, including guidance and a flowchart showing how
this document is applied, is also included in informative annexes. EO-sterilized devices that
have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.
| AAMI/ISO 10993-7:2008/(R)2012 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | AAMI/ISO 10993-7:2008/(R)2012 |
| Scope | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010) |
| Publisher | AAMI - Association for the Advancement of Medical Instrumentation/International Org. for Standardization |
| Languages | English |
| State | |
| Publication Year | 2007 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| ANSI | ANSI Approved |
| File Size | 1 file , 1.7 MB |
| ISBN(s) | 1570203326 |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 112 |
| Part of | AAMI STBK10-3 |
| Published | 12/10/2007 |
| AAMI/ISO 10993-7:2008/(R)2012 | ||
|---|---|---|
| History | Publisher Year | |
| AAMI/ISO 10993-7:2008/(R)2012 | 2010 | Current |
| AAMI/ISO 10993-7 | 1995 |
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