- What is Bioburden?
Bioburden is defined as the number of bacteria living on a surface that has not been sterilized.
- Why Biobuden?
The aim of bioburden testing is to measure the total number of viable microorganisms on a medical device, and then use the number to determine the most appropriate parameters for its final sterilization.
- When Bioburden?
Before sterilization, we should perform the test to ensure the safety and effectiveness of the EO sterilization process.
- Standard of Bioburden
ISO 11737-1:2006 Sterilization of medical devices —Microbiological methods —
Part 1:Determination of a population of microorganisms on products、ISO 11737-2:2009 Sterilization of medical devices —Microbiological methods —
Part 2：Tests of sterility performed in the definition, validation and maintenance of a sterilization process及USP-30 <71> Sterility Test
- How long for Bioburden?
In according with ISO regulations, it will take 7 days to get the result of Bioburden test.
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