Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

Standard published on 22.4.2015

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

Change published on 22.7.2020

Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area (ISO 11136:2014)

Standard published on 27.12.2017

Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area - Amendment 1 (ISO 11136:2014/Amd 1:2020)

Change published on 24.11.2021

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

Standard published on 16.9.2015

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

Change published on 22.7.2020

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Standard published on 16.9.2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

Change published on 12.7.2023

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

Standard published on 16.5.2018

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) (Endorsed by Asociación Espanola de Normalización in August of 2023.)

Standard published on 1.8.2023