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UNE-EN 556-2:2025 UNE
Status: Vigente/ 2025-06-18
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 17665:2025 UNE
Status: Vigente/ 2025-03-26
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)
UNE-EN 556-1:2025 UNE
Status: Current/ 2025-01-22
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN ISO 13408-1:2024 UNE
Status: Vigente/ 2024-11-27
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
UNE-EN ISO 11139:2020/A1:2024 UNE
Status: Vigente/ 2024-11-06
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions (ISO 11139:2018/Amd 1:2024)
UNE-EN ISO 17664-2:2024 UNE
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)
UNE-EN ISO 13004:2024 UNE
Status: Vigente/ 2024-02-14
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
UNE-CEN ISO/TS 11137-4:2023 UNE
Status: Vigente/ 2023-08-01
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) (Endorsed by Asociación Española de Normalización in August of 2023.)
UNE-EN ISO 11137-1:2015/A2:2020 UNE
Status: Vigente/ 2023-07-19
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)
UNE-EN ISO 11140-6:2023 UNE
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)
UNE-EN ISO 11137-2:2015/A1:2023 UNE
Status: Vigente/ 2023-07-12
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
UNE-EN ISO 25424:2020/A1:2022 UNE
Status: Vigente/ 2022-12-21
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
UNE-EN ISO 17664-1:2022 UNE
Status: Vigente/ 2022-06-01
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)
UNE-EN ISO 11138-8:2022 UNE
Status: Vigente/ 2022-03-16
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
UNE-EN ISO 11737-1:2018/A1:2022 UNE
Status: Vigente/ 2022-02-16
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)
UNE-EN ISO 13408-6:2022 UNE
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
UNE-EN IEC 61010-2-040:2021 UNE
Status: Vigente/ 2022-01-01
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (Endorsed by Asociación Española de Normalización in January of 2022.)
UNE-EN ISO 14160:2021 UNE
Status: Vigente/ 2021-09-01
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) (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN ISO 11737-2:2020 UNE
Status: Vigente/ 2020-12-16
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)
UNE-EN ISO 25424:2020 UNE
Status: Vigente/ 2020-10-14
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
UNE-EN ISO 11135:2015/A1:2020 UNE
Status: Vigente/ 2020-07-22
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)
UNE-EN ISO 18472:2020 UNE
Status: Vigente/ 2020-04-01
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
UNE-EN ISO 11139:2020 UNE
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)
UNE-EN ISO 11138-7:2020 UNE
Status: Vigente/ 2020-02-12
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)
UNE-EN ISO 28258:2013/A1:2019 UNE
Status: Vigente/ 2019-12-01
Soil quality - Digital exchange of soil-related data - Amendment 1 (ISO 28258:2013/Amd 1:2019) (Endorsed by Asociación Española de Normalización in December of 2019.)
UNE-EN ISO 11737-1:2018 UNE
Status: Vigente/ 2018-12-26
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
UNE-EN ISO 13408-2:2018 UNE
Status: Vigente/ 2018-10-24
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
UNE-EN ISO 11140-1:2015 UNE
Status: Vigente/ 2018-06-20
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
UNE-EN ISO 11137-3:2018 UNE
Status: Vigente/ 2018-05-16
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
UNE-EN ISO 11138-1:2017 UNE
Status: Vigente/ 2017-11-08
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
UNE-EN ISO 11138-2:2017 UNE
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
UNE-EN ISO 11138-4:2017 UNE
Status: Vigente/ 2017-10-11
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
UNE-EN ISO 11138-5:2017 UNE
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
UNE-EN ISO 11138-3:2017 UNE
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
UNE-EN ISO 13408-7:2015 UNE
Status: Vigente/ 2015-12-16
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
UNE-EN ISO 11137-1:2015 UNE
Status: Vigente/ 2015-09-16
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)
UNE-EN ISO 11137-2:2015 UNE
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
UNE-EN ISO 11135:2015 UNE
Status: Vigente/ 2015-04-22
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)
UNE-EN ISO 20857:2013 UNE
Status: Vigente/ 2013-11-27
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
UNE-EN ISO 13408-4:2011 UNE
Status: Vigente/ 2011-12-28
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
UNE-EN ISO 13408-3:2011 UNE
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
UNE-EN ISO 13408-5:2011 UNE
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
UNE-EN ISO 14937:2010 UNE
Status: Vigente/ 2010-05-26
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)
UNE-EN ISO 11140-3:2009 UNE
Status: Vigente/ 2009-09-09
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
UNE-EN ISO 15882:2009 UNE
Status: Vigente/ 2009-05-13
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
UNE-EN ISO 11140-4:2007 UNE
Status: Vigente/ 2007-09-19
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
ISO 17665:2024 ISO
Status: Published/ 2024-03-01
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11139:2018/Amd 1:2024 ISO
Status: Published/ 2024-01-17
Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
ISO 13408-1:2023 ISO
Status: Published/ 2023-08-15
Aseptic processing of health care products — Part 1: General requirements
ISO 11737-3:2023 ISO
Status: Published/ 2023-06-26
Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
