ISO 11737-3:2004
Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
- Standard No.
- ISO 11737-3:2004
- Release Date
- 2004
- Published By
- International Organization for Standardization (ISO)
- Status
- 2023-06
- Replace By
- ISO 11737-3:2023
- Latest
- ISO 11737-3:2023
- 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.
ISO 11737-3:2004 Referenced Document
- ISO 11737-1:1995 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products
ISO 11737-3:2004 history
- 2023 ISO 11737-3:2023 Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
- 2004 ISO 11737-3:2004 Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data
