YY/T 1623-2018 Translated English of Chinese Standard. (YYT 1623-2018, YY/T1623-2018, YYT1623-2018): Test method of effectiveness of sterilization process for reusable medical deviceshttps://www.chinesestandard.net, 30. mar. 2019 - 11 sider This standard specifies test methods of determining the effectiveness of sterilization process for reusable medical devices. This standard applies to tests that have established the effectiveness of the sterilization process, it does not apply to the validation of the sterilization process. |
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agar medium applicable aseptic process bacterial solution bioburden Biological indicators China 2015 version complete sterilization process concentration or double contains 108 CFU/mL contaminated device damp-heat sterilization device prior device to perform difficult to sterilize dilution and invert document dry the bacterial drying requirements effectiveness of sterilization elution equal to 107 ethylene oxide fill and rinse Growth promotion sensitivity infected inoculum which contains lumen or concave manufacturer specifies microbial counting Micropipette negative control neutralizer for sterilization number of microorganisms Obtain the average People's Republic perform gradient dilution Pharmacopoeia plate for microbial preparation method process for reusable process test cycle reagents recovery control replicated test data Republic of China Residual bacterial spores resistance criteria reusable medical devices rinsing by eluent select the usual specified in GB/T specifies the drying Sterile cotton-swabs sterile test sterilization of GB Sterilization of health sterilization processes GB test method Test microorganism total number volume volume IV wipe