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About This Item

 

Full Description

BS EN ISO 11737-2:2020 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.



Cross References:
ISO 10012
ISO 11737-1
ISO 13485
ISO/IEC 17025
ISO 11135-1
ISO/TS 11135-2
ISO 11137-1
ISO 11137-2
ISO 11138-2
ISO/TS 11139
ISO 14160
ISO 14161
ISO 14644-1
ISO 14644-4
ISO 14644-7
ISO 14937
ISO 17665-1
ISO 20857
ISO 9000
ISO 9001
ISO 90003
90/385/EEC
93/42/EEC
98/79/EC


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 11737-2:2020

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

    • Most Recent
  2. BS EN ISO 11737-2:2009


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

    • Historical Version
  3. BS 07/30157769 DC


    BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process

    • Historical Version
  4. BS EN ISO 11737-2:2000


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

    • Historical Version