Sterilization of medical devices -- Microbiological methods -- Part 3: Guidance on evaluation and interpretation of bioburden data
ISO 11737-3:2004 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.
ISO 11737-3:2004 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process.
ISO 11737-3:2004 is not applicable to microbiological data generated from sampling the environment in manufacturing areas.
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