Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ANSI/AAMI/ISO 10993-7 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, is also included in informative annexes. EO-sterilized devices that
have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.