Abstract

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.


General information 

  • Status
     : Withdrawn
    Publication date
     : 2004-07
  • Edition
     : 1
    Number of pages
     : 8
  • Technical Committee
     : ISO/TC 198 Sterilization of health care products
  • ICS
     :
    07.100.10 Medical microbiology
    11.080.01 Sterilization and disinfection in general

Life cycle

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