Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals TECHNICAL CORRIGENDUM 1
|Publication Date:||15 November 2009|
|ICS Code (Biological evaluation of medical devices):||11.100.20|
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).