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About This Item

 

Full Description

This part of ISO 11137 describes methods that can be used to establish the sterilization dose in accordance with one of the two approaches specified in 8.2 of ISO 11137-1:2006. The methods used in these approaches are:

  • dose setting to obtain a product-specific dose;
  • dose substantiation to verify a preselected dose of 25 kGy or 15 kGy.
  •  

    Document History

    1. BS EN ISO 11137-2:2015+A1:2023


      Sterilization of health care products. Radiation-Establishing the sterilization dose

      • Most Recent
    2. BS EN ISO 11137-2:2015


      Sterilization of health care products. Radiation-Establishing the sterilization dose

      • Historical Version
    3. BS EN ISO 11137-2:2013

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      Sterilization of health care products. Radiation-Establishing the sterilization dose

      • Historical Version
    4. BS EN ISO 11137-2:2012


      Sterilization of health care Products. Radiation-Establishing the sterilization dose

      • Historical Version
    5. BS EN ISO 11137-2:2007


      Sterilization of health care products. Radiation-Establishing the sterilization dose

      • Historical Version
    6. BS 09/30197784 DC


      BS EN ISO 11137-2. Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose

      • Historical Version
    7. BS 04/30048584 DC


      BS EN ISO 11137-2. Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose

      • Historical Version
    8. BS EN 552:1994


      Sterilization of medical devices. Validation and routine control of sterilization by irradiation

      • Historical Version