Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
This standard has been revised by ISO 10993-7:2008
Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.
A standard is reviewed every 5 years
Revisions / Corrigenda