YY/T 1302.2-2015 Translated English of Chinese Standard. YY/T1302.2-2015: Physical requirements and microbiological performance of ethylene oxide sterilization - Part 2: Microbiological aspectshttps://www.chinesestandard.net, 2019 M06 18 - 32 pages This part of YY/T 1302 specifies process definition, validation, process effectiveness maintenance, etc. for the microbiological aspects of ethylene oxide sterilization. This part applies to the ethylene oxide sterilization process for medical devices and other related products or materials, provides solutions to various microbiological aspects in the development and validation of ethylene oxide (EO) sterilization processes. |
Common terms and phrases
achieve amount of bioburden bacteria bioburden resistance biological indicator biological indicator/bioburden method catheter changes cycle development cycle parameters difficult to sterilize direct counting method document ensure EPCD establish ethylene oxide sterilization external PCD full bioburden method full positive result Guangzhou health care products humidity implement inert gas injection and removal internal PCD lower limit medical devices method or partial microbial challenge microbial performance qualification microbiological performance microorganisms obtain overkill method Overview partial cycle partial negative method position most difficult preconditioning process definition process development process parameters product design product family product load product package product sample product’s bioburden production-type cabinet production-type sterilizing cabinet recommended selected Setting value specified sterility assurance level sterility test sterilization cycle Sterilization of health sterilization parameters sterilization process sterilized load survival curve test cabinet test samples test sterilizing cabinet test-type tray validation cycle validation process value and range worst loading configuration wrapping film YY/T