This part of GB/T16886 specifies the allowable limits of EO and 2-chloroethanol (ECH) residues on a single medical device sterilized by ethylene oxide (EO), the detection steps of EO and ECH and the determination of whether the device can factory method. Additional background information including guidelines and flow charts for the application of this part are also given in the informative appendix. This section does not include EO sterilized devices that are not in contact with patients (such as in vitro diagnostic devices). Note: This section does not specify the limit of ethylene glycol (EG).
GB/T 16886.7-2015 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