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AAMI 11137-2

13th Edition, 2013

Complete Document

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

Includes all amendments and changes through Reaffirmation Notice , 2019

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SAME AS ISO 11137-2
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Description / Abstract:

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 10–6. 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.