This part of ISO 11137 describes procedures for determining the minimum dose required to meet a specified sterility requirement and procedures for confirming the use of 25 kGy or 15 kGy as a sterilization dose to achieve a sterility assurance level, SAL, of 10-6 set. This part of ISO 11137 also specifies sterilization dose verification procedures to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose determination and sterilization dose verifications.
EN ISO 11137-2:2015 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 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
EN ISO 11137-2:2015 history
2023EN ISO 11137-2:2015/A1:2023 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
2021EN ISO 11137-2:2015/prA1:2021 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
2015EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2013EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2012EN ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
2007EN ISO 11137-2:2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose