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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)

60.60   Standard published

CEN/TC 204

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)

60.60   Standard published

CEN/TC 204

Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)

60.60   Standard published

CEN/TC 204

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

60.60   Standard published

CEN/TC 204

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

60.60   Standard published

CEN/TC 204

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60   Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

60.60   Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

60.60   Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60   Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)

60.60   Standard published

CEN/TC 102

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

60.60   Standard published

CEN/TC 102

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

60.60   Standard published

CEN/TC 204

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)

60.60   Standard published

CEN/TC 204

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

60.60   Standard published

CEN/TC 204

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

60.60   Standard published

CEN/TC 204

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

60.60   Standard published

CEN/TC 204

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO 15193:2026)

60.60   Standard published

CEN/TC 140

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2026)

60.60   Standard published

CEN/TC 140



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