Historical
GB/T 16886.7-2001
Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals (TEXT OF DOCUMENT IS IN CHINESE)
This standard establishes permit limits of residuals of ethylene oxide (EO) and ethylene chlorohydrin (ECH) on unit product of ethylene oxide sterilization medical devices, test methods of ethylene oxide (EO) and ethylene chlorohydrin (ECH) as well as methods of determining whether devices can be released. The appendix presented in this standard also provides other background information and guidance. This standard does not take into account non-patient contact devices after ethylene oxide sterilization (e.g. vitro diagnostic devices).
CHINESE GB Standards [spc]