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ISO 11737-3:2004 PDF

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

First page of standard ISO 11737-3:2004Open preview (PDF)Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data
Title (English):
ISO 11737-3:2004

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

Document status:
Withdrawn
Format:
Electronic (PDF)
Number of pages:
8
Publication date:
July 13, 2004
Edition:
ISO IS 11737 edition 1 version 1
ICS:
07.100.10
Description (English):

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.

Technical details

Technical committee
ISO/TC 198 - Sterilization of health care products
SKU
ISO 11737-3:2004

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