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UNE-EN 60601-1:2008/A13:2024 UNE
Status: Vigente/ 2024-06-01
Medical electrical equipment - Part 1: General requirements for safety
UNE-EN 60601-1:2008/A2:2021 UNE
Status: Current/2024-05-22
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by Asociación Española de Normalización in December of 2022.)
UNE-EN IEC 60601-2-35:2021/A1:2024 UNE
Status: Vigente/ 2024-03-01
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use (Endorsed by Asociación Española de Normalización in March of 2024.)
UNE-EN IEC 60601-2-76:2019/A1:2023 UNE
Status: Vigente/ 2023-11-01
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (Endorsed by Asociación Española de Normalización in November of 2023.)
UNE-EN 60601-1-6:2010/A2:2021 UNE
Status: Vigente/ 2021-09-01
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN 60601-1-10:2008/A2:2021 UNE
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN 60601-1-9:2008/A2:2020 UNE
Status: Vigente/ 2020-10-01
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (Endorsed by Asociación Española de Normalización in October of 2020.)
UNE-EN 60601-1-12:2015/A1:2020 UNE
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (Endorsed by Asociación Española de Normalización in October of 2020.)
UNE-EN 62366-1:2015/A1:2020 UNE
Status: Vigente/ 2020-09-01
Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by Asociación Española de Normalización in September of 2020.)
UNE-EN IEC 80601-2-30:2019 UNE
Status: Vigente/ 2019-07-01
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Endorsed by Asociación Española de Normalización in July of 2019.)
PNE-prEN IEC 80601-2-30:2025 PROY
Status: Procedure
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
PNE-prEN IEC 62304:2021 PROY
Health software - Software life cycle processes
