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Number of results 907
UNE-EN 14349:2025 UNE
Status: Vigente/ 2025-12-10
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
UNE-EN ISO 15883-7:2025 UNE
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)
UNE-EN 868-4:2025 UNE
Status: Vigente/ 2025-11-12
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN 14180:2025 UNE
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
UNE-EN 868-7:2025 UNE
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-2:2025 UNE
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
UNE-EN ISO 14155:2021/A11:2025 UNE
Clinical investigation of medical devices for human subjects - Good clinical practice
UNE-EN 868-6:2025 UNE
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-3:2025 UNE
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
UNE-EN ISO 15883-1:2025 UNE
Status: Vigente/ 2025-10-22
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
UNE-EN ISO 15883-2:2025 UNE
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024)
UNE-EN ISO 15883-3:2025 UNE
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024)
UNE-EN ISO 10993-4:2018/A1:2025 UNE
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)
UNE-EN ISO 10993-5:2009/A11:2025 UNE
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
UNE-EN ISO 8871-5:2025 UNE
Status: Vigente/ 2025-10-08
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2025)
UNE-EN 14683:2025 UNE
Medical face masks - Requirements and test methods
UNE-EN 13795-1:2025 UNE
Status: Vigente/ 2025-09-24
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
UNE-EN 13795-2:2025 UNE
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
UNE-EN 1657:2025 UNE
Status: Vigente/ 2025-07-30
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
UNE-EN 17122:2020+A1:2025 UNE
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2
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 ISO 80369-2:2025 UNE
Status: Vigente/ 2025-07-16
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)
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 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 8362-2:2024 UNE
Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)
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 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)
