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UNE-EN ISO 18562-1:2025 UNE
Status: Vigente/ 2025-05-07
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
UNE-EN ISO 18562-2:2025 UNE
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
UNE-EN ISO 18562-3:2025 UNE
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
UNE-EN ISO 18562-4:2025 UNE
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
UNE-EN ISO 80601-2-84:2025 UNE
Status: Current/ 2025-01-22
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
UNE-EN ISO 5362:2025 UNE
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
UNE-EN ISO 80601-2-12:2025 UNE
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
UNE-EN ISO 19223:2024 UNE
Status: Vigente/ 2024-11-27
Lung ventilators and related equipment - Vocabulary and semantics (ISO 19223:2019)
UNE-EN ISO 4135:2024 UNE
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2022)
UNE-EN ISO 81060-2:2020/A2:2024 UNE
Status: Vigente/ 2024-11-06
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
UNE-EN IEC 80601-2-78:2020/A1:2024 UNE
Status: Current/ 2024-11-01
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN ISO 80601-2-79:2024 UNE
Status: Vigente/ 2024-10-01
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2024) (Endorsed by Asociación Española de Normalización in October of 2024.)
UNE-EN ISO 80601-2-80:2024 UNE
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024) (Endorsed by Asociación Española de Normalización in October of 2024.)
UNE-EN ISO 10524-1:2019/A1:2024 UNE
Status: Current/2024-06-05
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1 (ISO 10524-1:2018/Amd 1:2023)
UNE-EN ISO 5367:2024 UNE
Status: Current/2024-05-22
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
UNE-EN ISO 15002:2024 UNE
Status: Vigente/ 2024-05-01
Flow control devices for connection to a medical gas supply system (ISO 15002:2023) (Endorsed by Asociación Española de Normalización in May of 2024.)
UNE-EN ISO 27427:2024 UNE
Status: Vigente/ 2024-03-20
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
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 10651-4:2023 UNE
Status: Vigente/ 2024-01-03
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
UNE-EN IEC 60601-2-19:2021/A1:2023 UNE
Status: Vigente/ 2024-01-01
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Endorsed by Asociación Española de Normalización in January of 2024.)
UNE-EN IEC 60601-2-20:2020/A1:2023 UNE
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (Endorsed by Asociación Española de Normalización in January of 2024.)
UNE-EN IEC 60601-2-21:2021/A1:2023 UNE
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Endorsed by Asociación Española de Normalización in January of 2024.)
UNE-EN ISO 80601-2-55:2018/A1:2023 UNE
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023) (Endorsed by Asociación Española de Normalización in January of 2024.)
UNE-EN ISO 5361:2023 UNE
Status: Vigente/ 2023-12-13
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)
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-EN ISO 80601-2-72:2023 UNE
Status: Vigente/ 2023-08-01
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023) (Endorsed by Asociación Española de Normalización in August of 2023.)
UNE-EN ISO 80369-3:2017/A1:2023 UNE
Status: Vigente/ 2023-07-19
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 23368:2023 UNE
Status: Vigente/ 2023-04-12
Anaesthetic and respiratory equipment - Low-flow nasal cannulae for oxygen therapy (ISO 23368:2022)
UNE-EN ISO 16628:2023 UNE
Status: Vigente/ 2023-02-22
Anaesthetic and respiratory equipment - Tracheobronchial tubes (ISO 16628:2022)
UNE-EN ISO 80601-2-13:2023 UNE
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
UNE-EN ISO 26825:2023 UNE
Status: Vigente/ 2023-02-01
Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)
UNE-EN ISO 18778:2022 UNE
Status: Vigente/ 2023-01-01
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022) (Endorsed by Asociación Española de Normalización in January of 2023.)
UNE-EN ISO 10079-2:2022 UNE
Status: Vigente/ 2022-12-21
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)
UNE-EN ISO 10079-3:2022 UNE
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
UNE-EN ISO 23372:2022 UNE
Anaesthetic and respiratory equipment - Air entrainment devices (ISO 23372:2022)
UNE-EN 13348:2016 UNE
Status: Vigente/ 2022-10-19
Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
UNE-EN ISO 10651-5:2022 UNE
Status: Vigente/ 2022-05-25
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (ISO 10651-5:2006)
UNE-EN 13544-2:2003+A1:2010 UNE
Status: Vigente/ 2022-03-15
Respiratory therapy equipment - Part 2: Tubing and connectors
UNE-EN ISO 80601-2-85:2021 UNE
Status: Vigente/ 2021-11-24
Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)
UNE-EN ISO 80601-2-67:2021 UNE
Status: Vigente/ 2021-11-10
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)
UNE-EN ISO 80601-2-69:2021 UNE
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
UNE-EN ISO 80601-2-90:2021 UNE
Status: Vigente/ 2021-11-01
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO 80601-2-90:2021) (Endorsed by Asociación Española de Normalización in November of 2021.)
UNE-EN IEC 60601-2-19:2021 UNE
Status: Vigente/ 2021-09-01
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN IEC 60601-2-21:2021 UNE
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN 80369-5:2017/AC:2021-06 UNE
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
UNE-EN ISO 81060-2:2020/A1:2021 UNE
Status: Vigente/ 2021-04-28
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
UNE-EN ISO 7376:2021 UNE
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)
UNE-EN ISO 17510:2021 UNE
Status: Vigente/ 2021-04-07
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
UNE-EN ISO 80601-2-70:2020 UNE
Status: Vigente/ 2021-01-01
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020) (Endorsed by Asociación Española de Normalización in January of 2021.)
