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AAMI/ISO 11137-2:2012

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 05/03/2012

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Full Description

This part of ISO 11137 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 106. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
 

Product Details

Published:
05/03/2012
ISBN(s):
1570204446
ANSI:
ANSI Approved
Number of Pages:
94
File Size:
1 file , 850 KB
Same As:
ISO 11137-2:2012
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 11137-2:2013 (R2019)


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

    • Most Recent

  2. AAMI/ISO 11137-2:2012

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

    • Historical Version

  3. AAMI/ISO 11137-2:2006


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Corrected 21 April 2009)

    • Historical Version

  4. AAMI/ISO 11137-2:2006


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

    • Historical Version