Revision of Annex E, Single batch release
Edition 2018-10

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2023-04

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Edition 2006-04

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1
Edition 2013-07

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
Edition 2018-11

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
Edition 2017-06

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
Edition 2021-07

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Edition 2019-12

Graphic technology - Process control for the production of half-tone colour separations, proof and production prints - Part 8: Validation print processes working directly from digital data
Edition 2021-05

Oil and gas industries including lower carbon energy - Wet thermal insulation systems for pipelines and subsea equipment - Part 1: Validation of materials and insulation systems
Edition 2023-10