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Number of results 424
UNE-EN ISO 13408-1:2024
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
UNE-EN ISO 17664-2:2024
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 11139:2020/A1:2024
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 13004:2024
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
UNE-CEN ISO/TS 11137-4:2023
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 11140-6:2023
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
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
UNE-EN ISO 13131:2023
Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021)
UNE-EN ISO 25424:2020/A1:2022
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
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
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 15223-1:2022
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
UNE-EN ISO 13408-6:2022
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
UNE-EN ISO 11737-1:2018/A1:2022
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 170002:2022
Accessibility requirements for sign elements in buildings.
UNE-EN 17210:2021
Accessibility and usability of the built environment - Functional requirements
UNE-EN ISO 14160:2021
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
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
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
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 11137-1:2015/A2:2020
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 18472:2020
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2018)
UNE-EN ISO 11139:2020
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
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)