ISO 11737-3:2004

Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data

Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data

Digital Document2004 edition2004Purchase Options

Referenced standards

ISO 11737-1:1995
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ISO 11737-3:2004

Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data

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.

Edition2004
Standard Part No3
Published Date2004
Published ByInternational Standardization Organisation
Page Count8