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Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)

60.60 Standard published

CEN/TC 102

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 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 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

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)

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 2: Sterilizing filtration (ISO 13408-2:2018)

60.60 Standard published

CEN/TC 204

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

60.60 Standard published

CEN/TC 204

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

60.60 Standard published

CEN/TC 204

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)

60.60 Standard published

CEN/TC 102

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

60.60 Standard published

CEN/TC 204

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)

60.60 Standard published

CEN/TC 204

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)

60.60 Standard published

CEN/TC 204