Bioburden Testing and Sterility Testing of Medical Devices | 合法醫療器材資訊網

Thepurposeofthebioburdensuitabilitytest(alsocalledmethodvalidation)istoensurethatthebioburdentestmethodiseffectiveinrecoveringmicroorganisms ...

Producing safe products is a core goal of all medical device manufacturers and sterility assurance is a key component in achieving that goal.  Many single use medical devices are terminally sterilized by ethylene oxide or radiation methods such as gamma or e-beam.  The FDA and other regulatory bodies requires that the sterilization process be validated and these validations typically require a bioburden and sterility testing.  Sterility testing and bioburden testing are also performed on devices as part of routine quality control.

A bioburden test determines how many microbes are on the medical device.  Before performing the test, a suitability test must first be performed.   The purpose of the bioburden suitability test (also called method validation) is to ensure that the bioburden test method is effective in recovering microorganisms...