BS EN ISO 10993-7:2008
Biological evaluation of medical devices - Ethylene oxide sterilization residuals
- Standard No.
- BS EN ISO 10993-7:2008
- Release Date
- 2008
- Published By
- British Standards Institution (BSI)
- Status
- Replace By
- BS EN ISO 10993-7:2008+A1:2022
- Latest
- BS EN ISO 10993-7:2008+A1:2022
- 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.
BS EN ISO 10993-7:2008 history
- 1970 BS EN ISO 10993-7:2008+A1:2022 Biological evaluation of medical devices. Ethylene oxide sterilization residuals
- 2008 BS EN ISO 10993-7:2008 Biological evaluation of medical devices - Ethylene oxide sterilization residuals
