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 pages
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.
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20 test samples additional test sample Air flow aluminum foil barrier for porous barrier test kits blood agar plate Braunschweig casein peptone-soybean peptone Cell Cultures chloride/g 5 Agar/g Coefficient of variation Conforming/Non-conforming cooling Culture Collection described in 3.6.1 dilution evaluation freshly prepared distilled GB/T imply endorsement incubated information is drawn information is given Inter-laboratory laboratories listed in Table material or microorganisms materials under moist medical device manufacturers medical device package medium methods given microbial barrier properties microbial barrier test microbial suspension milliliter moist conditions negative check 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 distilled water PTFE quartz powder single-sided smooth Sodium chloride/g solid components listed steam sterilizer sterile medical device sterilizer at 121 temperature Test implementation test microorganisms test report Testing the microbial thread lid total number type test users YY/T