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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080257.pdf
See if this answers any of your questions.
I am also looking for information to quantify bioburden limits and corelating bioburden results with sterilization test results.
See if this answers any of your questions.
I am also looking for information to quantify bioburden limits and corelating bioburden results with sterilization test results.