YY/T 1463-2016 Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites

Scope

This standard provides guidance on selecting appropriate microbial challenges, suitable contamination sites, contamination methods, and techniques for recovering contaminated microorganisms during the sterilization confirmation process.
This standard applies to sterilization confirmation tests conducted by medical device manufacturers, but not to routine sterilization tests.
This standard does not apply to microbial challenges or contamination processes in the confirmation of medical device cleaning effectiveness or disinfection confirmation.

Development Information

Referenced Standards

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