DANSK DS/EN ISO 11137-2 [ Revised ]

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

standard by Dansk Standard , 04/27/2012

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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.

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Edition:: 12
Published:: 04/27/2012
Number of Pages:: 90
File Size:: 1 file , 670 KB
Product Code(s):: DS-081, DS-081

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