YY/T 1268-2015 Translated English of Chinese Standard. (YYT 1268-2015, YY/T1268-2015, YYT1268-2015): Product adoption and process equivalence for ethylene oxide sterilizationhttps://www.chinesestandard.net, 27. okt. 2018 - 21 sider This standard specifies the equivalence of the sterilization process when using new equipment in the process of adopting new product or changed product into the originally validated ethylene oxide sterilization process. This standard applies to medical devices that have been treated by ethylene oxide (EO) sterilization and that use conventional release or parametric release. |
Almindelige termer og sætninger
analysis and evaluation analytical area Appendix applicable bioburden level biocompatibility breather material candidate equipment carry out evaluation challenging process change control characteristics As compared control range delivered demonstrate determine difficult to sterilize document effect ethylene oxide processing ethylene oxide product ethylene oxide residue ethylene oxide sterilization evaluate the candidate existing ethylene oxide existing product family or ethylene gas residence GB/T humidity distribution implement include or refer initial equipment installation qualification load configuration microbiological evaluation operational qualification oxide processing group oxide product family oxide sterilization process packaging system porosity process analysis process challenge device Process data analysis process equivalence process parameters product adoption product or process protective packaging qualified product representative product requirements of ISO residual level selected time point standard sterile barrier system sterility assurance level sterilization chamber sterilization cycle sterilization process equipment sterilization specialist sterilization techniques technical review indicates temperature and humidity validated ethylene oxide validated process validated sterilization process