ISO 11737-3 Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
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ISO 11737-3 Document Information:
Title
Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
International Organization for Standardization
Publication Date:
Jul 1, 2004
Scope:
This part of ISO 11737 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.
This part of ISO 11737 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process.
This part of ISO 11737 is not applicable to microbiological data generated from sampling the environment in manufacturing areas.
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