BSI - BS EN ISO 10993-7
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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| Organization: | BSI |
| Publication Date: | 31 December 2008 |
| Status: | inactive |
| Page Count: | 98 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of ISO 10993 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, are also included in the informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.
NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).
Document History
December 31, 2008
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
A description is not available for this item.
December 31, 2008
Biological evaluation of medical devices Ethylene oxide sterilization residuals
A description is not available for this item.
BS EN ISO 10993-7
December 31, 2008
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
April 15, 1996
Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
A description is not available for this item.