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NS-EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

standard by Standards Norway NS-EN ISO , 09/01/2015

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ADOPTED_FROM:EN ISO 11137-2:2015 ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
 

Product Details

Published:
09/01/2015
Number of Pages:
88
 

Document History

  1. NS-EN ISO 11137-2:2015

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    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    • Most Recent

  2. NS-EN ISO 11137-2:2013


    Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    • Historical Version

  3. NS-EN ISO 11137-2:2012


    Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2012)

    • Historical Version

  4. NS-EN ISO 11137-2:2007/AC:2009


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009)

    • Historical Version

  5. NS-EN ISO 11137-2:2007


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

    • Historical Version

  6. NS-EN ISO 11137-2:2006


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)

    • Historical Version

  7. NS-EN 552:1994/A2:2000


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

    • Historical Version

  8. NS-EN 552:1994/A1:1999


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

    • Historical Version

  9. NS-EN 552:1994


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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. NS-EN ISO 11137-2:2015/A1:2023


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)