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ISO 11737-2:1998 [ Withdrawn ]

Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process

standard by International Organization for Standardization , 07/01/1998

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Full Description

This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when validating a sterilization process.

This part of ISO 11737 is not applicable to:

  • sterility testing for routine release of product that has been subjected to a sterilization process;
  • performance of a pharmacopoeial test for sterility; or
  • culturing of biological indicators, including inoculated products.
 

Product Details

Published:
07/01/1998
Number of Pages:
13
File Size:
1 file , 60 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 11737-2:2019


    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

    • Most Recent

  2. ISO 11737-2:2009


    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

    • Historical Version

  3. ISO 11737-2:1998

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    Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process

    • Historical Version