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).
ANSI/AAMI/ISO 10993-7:2008 history
2008ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals