$138
ISO 10993-7:2008
2008
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
- Format:
- Language(s) :
- Published :
- English
- 10/15/2008
ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
| ISO 10993-7:2008 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | ISO 10993-7:2008 |
| Scope | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
| Publisher | ISO - International Organization for Standardization |
| Languages | English |
| State | |
| Publication Year | 2008 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| Edition | 2nd |
| File Size | 1 file , 1.8 MB |
| Note | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages | 94 |
| Published | 10/15/2008 |
| Same As | ISO 10993-7:2008 |
| ISO 10993-7:2008 | ||
|---|---|---|
| History | Publisher Year | |
| ISO 10993-7:2008 | 2008 | Current |
| ISO 10993-7:1995 | 1995 |
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