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ISO 11137-2:2012 [ Withdrawn ]

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

standard by International Organization for Standardization , 03/15/2012

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Full Description

ISO 11137-2:2011 specifies methods of 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 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

 

Product Details

Published:
03/15/2012
File Size:
1 file , 1.3 MB
Same As:
BS EN ISO 11137-2:2012, AAMI/ISO 11137-2:2012, DIN EN ISO 11137-2
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 11137-2:2013


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    • Most Recent

  2. ISO 11137-2:2012

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    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    • Historical Version

  3. ISO 11137-2/Cor1:2009


    Corrigendum

    • Historical Version

  4. ISO 11137-2:2006


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    • Historical Version

  5. ISO 11137:1995


    Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization

    • Historical Version