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ISO 11137-2:2013

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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ISO 11137-2:2013

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

PUBLISH DATE 2013
ISO 11137-2:2013

ISO 11137-2:2013 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

SDO ISO: International Organization for Standardization
Document Number ISO 11137
Publication Date June 1, 2013
Language en - English
Page Count 76
Revision Level
Supercedes
Committee ISO/TC 198
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