ISO 10993-7:2008
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2008 |
| No. of Pages | 86 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | ISO/TC 194 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |