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

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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.




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Claudia's Notes:
ISO 11137-2 is one of a 3-part series on the sterilization of health care products using radiation that replaced the original edition, ISO 11137:1995.  The other two documents in the series are:

    ISO 11137-1:2006, “Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”

    ISO 11137-3:2006, “Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects”

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 11137-2:2013

Revision Level




Publication Date

June 1, 2013

Committee Number

ISO/TC 198