Standard Number: YY/T 1463-2016(YY/T1463-2016)
Chinese:医疗器械灭菌确认 选择微生物挑战和染菌部位的指南
English:Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
Effective Date:2017-01-01
ICS:11.080.01
Standard Applicability:This standard specifies techniques for selecting the appropriate microbial challenge, the appropriate staining site, the staining method, and the resuscitation of stained microorganisms during the sterilization confirmation process. This standard applies to medical device manufacturers conducting sterilization confirmation tests. This standard does not apply to routine sterilization tests, microbial challenges or staining processes in the confirmation of cleaning effectiveness or sterilization confirmation of medical devices.
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