ISO 11137-2:2013 PDF

Scope: This part of ISO 11137 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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

ISO 11137-2:2013 Referenced Document

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 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update

2022 ISO 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
2013 ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2012 ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2009 ISO 11137-2:2006/Cor 1:2009 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
2006 ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose