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AAMI 11137-2
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AAMI 11137-2 2013 Edition, January 1, 2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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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.
This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.