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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 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 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 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 407:2024 UNE
Status: Current/2024-04-17
Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2023)
UNE-EN ISO 27427:2024 UNE
Status: Vigente/ 2024-03-20
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
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 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 21917:2023 UNE
Status: Vigente/ 2023-09-20
Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
UNE-EN ISO 81060-3:2023 UNE
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
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 4135:2023 UNE
Status: Anulada/ 2024-11-27
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 23371:2023 UNE
Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices (ISO 23371:2022)
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 ISO 10079-1:2022 UNE
Status: Vigente/ 2022-11-23
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
UNE-EN ISO 10079-4:2022 UNE
Status: Vigente/ 2022-06-22
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
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 ISO 407:2022 UNE
Status: Anulada/ 2024-04-17
Small medical gas cylinders - Pin-index yoke-type valve connections (ISO 407:2021)
UNE-EN ISO 19223:2022 UNE
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 80369-5:2017/AC:2021-06 UNE
Status: Vigente/ 2021-09-01
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 8836:2021 UNE
Suction catheters for use in the respiratory tract (ISO 8836:2019)
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 80601-2-12:2021 UNE
Status: Anulada/ 2025-01-22
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
UNE-EN ISO 9170-1:2021 UNE
Status: Vigente/ 2021-01-20
Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2017)
UNE-EN ISO 11117:2020 UNE
Status: Vigente/ 2020-10-28
Gas cylinders - Valve protection caps and guards - Design, construction and tests (ISO 11117:2019)
UNE-EN ISO 81060-2:2020 UNE
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
UNE-EN ISO 11197:2020 UNE
Status: Vigente/ 2020-10-14
Medical supply units (ISO 11197:2019)
UNE-EN ISO 27427:2020 UNE
Status: Anulada/ 2024-03-20
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2013)
UNE-EN ISO 20789:2020 UNE
Status: Vigente/ 2020-09-23
Anaesthetic and respiratory equipment - Passive humidifiers (ISO 20789:2018)
UNE-EN ISO 80601-2-13:2013/A1:2020 UNE
Status: Anulada/ 2025-07-01
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
