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ISO/CD 11137-2

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

General information

30.20     Aug 21, 2025

ISO

ISO/TC 198

International Standard

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 11137-2:2013

PUBLISHED
ISO 11137-2:2013/Amd 1:2022

NOW

IN_DEVELOPMENT
ISO/CD 11137-2
30.20 CD study/ballot initiated
Aug 21, 2025

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