YY/T 0681.14-2018 Translated English of Chinese Standard. (YYT 0681.14-2018, YY/T0681.14-2018, YYT0681.14-2018): Test methods for sterile medical device package - Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air
https://www.chinesestandard.net, 2019 M04 7 - 20 páginas
This Part specifies the methods for testing the microbial barrier for porous packaging materials under moist conditions and with passage of air. The test methods given in this Part apply to the packaging materials for terminally sterilized medical devices.
Air flow aluminum foil barrier for porous barrier test kits blood agar plate Braunschweig casein peptone-soybean peptone Cell Cultures China 2015 Edition chloride/g 5 Agar/g Coefficient of variation Conforming/Non-conforming cooling Culture Collection dilution evaluation extract/g 1 Yeast freshly prepared distilled GB/T imply endorsement incubated information is drawn information is given Intra-laboratory laboratories listed in Table manufacturer’s or customer’s materials under moist medical device manufacturers medical packaging medium methods given microbial barrier properties microbial barrier test microbial suspension milliliter moist conditions negative check nonwoven number of colonies nutrition agar plate passage of air peptone-soybean peptone broth Petri dish porous packaging materials positive check Powdered quartz Precision and bias prepared as 4.5 prepared distilled water PTFE quartz powder single-sided smooth Sodium chloride/g steam sterilizer sterile medical device sterilizer at 121 temperature Test implementation test microorganisms test report test under moist Testing the microbial thread lid total number type test users www.ChineseStandard.net YY/T