Clear filters Apply
Results for:
Number of results 891
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-CEN ISO/TR 24971:2025 IN UNE
Status: Vigente/ 2025-04-23
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
UNE-EN 1865-6:2025 UNE
Patient handling equipment used in ambulances - Part 6: Powered chairs
UNE-EN 455-1:2020+A2:2025 UNE
Status: Vigente/ 2025-04-09
Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
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 1865-2:2025 UNE
Status: Valid/2025-03-19
Patient handling equipment used in ambulances - Part 2: Power assisted stretcher
UNE-EN ISO 23500-1:2025 UNE
Status: Vigente/ 2025-03-05
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)
UNE-EN ISO 23500-2:2025 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
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 11608-4:2022 UNE
Status: Vigente/ 2025-01-08
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022, Corrected version 2024-12)
UNE-EN 455-2:2024 UNE
Status: Vigente/ 2024-12-04
Medical gloves for single use - Part 2: Requirements and testing for physical properties
UNE-EN ISO 23500-3:2024 UNE
Status: Vigente/ 2024-11-27
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
UNE-EN ISO 13408-1:2024 UNE
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
UNE-EN ISO 23500-4:2024 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
UNE-EN ISO 23500-5:2024 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
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 17854:2024 UNE
Antimicrobial wound dressings - Requirements and test method
UNE-EN 17430:2024 UNE
Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and requirements (phase 2/step 2)
UNE-EN ISO 81060-2:2020/A2:2024 UNE
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
UNE-EN ISO 8536-13:2024 UNE
Status: Current/ 2024-11-01
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024) (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN ISO 15378:2018/A1:2024 UNE
Status: Vigente/ 2024-09-25
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes (ISO 15378:2017/Amd 1:2024)
UNE-EN ISO 10555-1:2024 UNE
Status: Vigente/ 2024-09-11
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)
UNE-EN ISO 10555-4:2024 UNE
Status: Vigente/ 2024-07-17
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
UNE-EN 1789:2021+A1:2024 UNE
Medical vehicles and their equipment - Road ambulances
UNE-EN 455-3:2024 UNE
Status: Vigente/ 2024-06-19
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
UNE-EN 13697:2024 UNE
Status: Current/2024-06-05
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas without mechanical action - Test method and requirements without mechanical action (phase 2, step 2)
UNE-EN 17846:2024 UNE
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2)
UNE-EN ISO 8637-2:2024 UNE
Status: Vigente/ 2024-06-01
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024) (Endorsed by Asociación Española de Normalización in June of 2024.)
UNE-EN ISO 10993-17:2024 UNE
Status: Current/2024-05-22
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
UNE-EN ISO 10993-18:2021/A1:2024 UNE
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
UNE-EN ISO 11607-1:2020/A1:2024 UNE
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)
UNE-EN ISO 11607-2:2020/A1:2024 UNE
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)
UNE-EN 13976-1:2019 UNE
Status: Vigente/ 2024-03-01
Rescue systems - Transportation of incubators - Part 1: Interface requirements
UNE-EN 13976-2:2019 UNE
Rescue systems - Transportation of incubators - Part 2: System requirements
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-EN ISO 24072:2024 UNE
Status: Vigente/ 2024-01-24
Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)
UNE-EN ISO 10993-15:2024 UNE
Status: Vigente/ 2024-01-17
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
UNE-CEN/TR 18010:2023 UNE
Status: Vigente/ 2023-12-01
Chemical disinfectants and antiseptics - Information on the preparation of spores and determination/exclusion of sporistatical activity (Endorsed by Asociación Española de Normalización in December of 2023.)
UNE-EN ISO 7439:2023 UNE
Status: Vigente/ 2023-11-15
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)
UNE-EN ISO 3826-1:2020/A1:2023 UNE
Status: Vigente/ 2023-10-25
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
UNE-EN ISO 10993-10:2023 UNE
Status: Vigente/ 2023-10-18
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
UNE-EN ISO 11608-5:2023 UNE
Status: Vigente/ 2023-10-04
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
UNE-EN ISO 21649:2023 UNE
Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
UNE-EN ISO 81060-3:2023 UNE
Status: Vigente/ 2023-09-20
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
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 80369-3:2017/A1:2023 UNE
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)
UNE-EN ISO 10993-2:2023 UNE
Status: Vigente/ 2023-07-12
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
