ISO 11737-3
Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
inactive
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| Organization: | ISO |
| Publication Date: | 1 July 2004 |
| Status: | inactive |
| Page Count: | 14 |
| ICS Code (Medical microbiology): | 07.100.10 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
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.
Document History
June 1, 2023
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Inclusions
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins...
ISO 11737-3
July 1, 2004
Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data
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...