AAMI/ISO 11137-2:2012 Historical

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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. See more

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Document History

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


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

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  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

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Product Details

Published:

05/03/2012

ISBN(s):

1570204446

ANSI:

ANSI Approved

Number of Pages:

94

File Size:

1 file

Same As:

ISO 11137-2:2012

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus