GSO ISO 11137-2:2014

ISO 11137-2:2013

Gulf Standard Current Edition · Approved on 25 December 2014

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

GSO ISO 11137-2:2014 Files

English 68 Pages

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GSO ISO 11137-2:2014 Scope

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.