Bioburden Introduction

Industrial Management Consulting
Industrial Management Consulting

  • 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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