This standard specifies the allowable limits of ethylene oxide (EO) and 2-chloroethanol (ECH) residues on medical devices sterilized by ethylene oxide, and the measurement methods for ethylene oxide and 2-chloroethanol and methods for determining whether a device can be released. Additional background information and guidance are given in the appendices to this standard prompt. This standard does not cover those ethylene oxide sterilized devices that do not come into contact with patients (eg, in vitro diagnostic devices).
GB/T 16886.7-2001 history
2015GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
2001GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals