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ISO 11137-2:2012

Withdrawn Date published:

Warning: Withdrawn Standard. This document has been replaced by:

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

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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Pages: 70

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  • AS/NZS ISO 11137.1:2006

    Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices

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  • BS EN 556-1:2024

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Pages: 70

Previous versions