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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 301489-28 V2.1.1 UNE
Status: Current/ 2024-12-01
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 28: Specific conditions for wireless digital video links; Harmonised Standard for ElectroMagnetic Compatibility EMC for digital wireless video links between 1.3 GHz & 78 GHz. (Endorsed by Asociación Española de Normalización in December of 2024.)
UNE-EN ISO 16571:2024 UNE
Status: Vigente/ 2024-11-27
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
UNE-EN IEC 60601-2-75:2019/A1:2024 UNE
Status: Current/ 2024-11-01
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (Endorsed by Asociación Española de Normalización in November of 2024.)
UNE-EN IEC 80601-2-78:2020/A1:2024 UNE
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 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 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/A1:2013 UNE
Status: Current/2024-05-22
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by AENOR in November of 2013.)
UNE-EN 60601-1-8:2008/A11:2017 UNE
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Endorsed by Asociación Española de Normalización in April of 2017.)
UNE-EN 60601-1-8:2008/A2:2021 UNE
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN 60601-1:2008/A2:2021 UNE
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 80601-2-26:2020/A1:2024 UNE
Status: Vigente/ 2024-05-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in May of 2024.)
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 80601-2-77:2021/A1:2023 UNE
Status: Vigente/ 2024-02-01
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Endorsed by Asociación Española de Normalización in February of 2024.)
UNE-EN 15986:2011 UNE
Status: Vigente/ 2023-05-31
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN IEC 80601-2-59:2019/A1:2023 UNE
Status: Vigente/ 2023-04-01
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in April of 2023.)
UNE-EN ISO 13485:2018/A11:2022 UNE
Status: Vigente/ 2022-09-21
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
UNE-EN ISO 14971:2020/A11:2022 UNE
Status: Vigente/ 2022-06-22
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 15223-1:2022 UNE
Status: Vigente/ 2022-03-16
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
UNE-EN IEC 81001-5-1:2022 UNE
Status: Vigente/ 2022-03-01
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (Endorsed by Asociación Española de Normalización in March of 2022.)
UNE-EN ISO 20417:2021 UNE
Status: Vigente/ 2022-01-05
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
UNE-EN IEC 80601-2-26:2020/AC:2021-10 UNE
Status: Vigente/ 2021-12-01
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (Endorsed by Asociación Española de Normalización in December of 2021.)
UNE-EN IEC 80001-1:2021 UNE
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (Endorsed by Asociación Española de Normalización in December of 2021.)
UNE-EN ISO 14155:2021 UNE
Status: Vigente/ 2021-09-22
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
UNE-EN 60601-1-11:2015/A1:2021 UNE
Status: Vigente/ 2021-09-01
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Endorsed by Asociación Española de Normalización in September of 2021.)
UNE-EN 60601-1-6:2010/A2:2021 UNE
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 IEC 60601-2-35:2021 UNE
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (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 60601-1-2:2015/A1:2021 UNE
Status: Vigente/ 2021-05-01
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by Asociación Española de Normalización in May of 2021.)
UNE-EN IEC 60601-2-22:2020 UNE
Status: Vigente/ 2021-01-01
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (Endorsed by Asociación Española de Normalización in January of 2021.)
UNE-EN 13718-2:2015+A1:2020 UNE
Status: Vigente/ 2020-11-11
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
UNE-EN 13718-1:2015+A1:2020 UNE
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
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-CEN ISO/TR 20416:2020 UNE
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020) (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 ISO 14971:2020 UNE
Status: Vigente/ 2020-09-23
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 80601-2-78:2020 UNE
Status: Vigente/ 2020-05-01
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 May of 2020.)
UNE-EN IEC 60601-2-31:2020 UNE
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 80601-2-60:2020 UNE
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 80601-2-59:2019 UNE
Status: Vigente/ 2019-11-01
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (Endorsed by Asociación Española de Normalización in November of 2019.)
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.)
UNE-EN 301489-31 V2.2.1 UNE
Status: Vigente/ 2019-06-01
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in June of 2019.)
UNE-EN 301489-29 V2.2.1 UNE
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in June of 2019.)
UNE-EN 301489-27 V2.2.1 UNE
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) operating in the 402 MHz to 405 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in June of 2019.)
UNE-EN ISO 15378:2018 UNE
Status: Vigente/ 2018-10-24
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
UNE-EN ISO 13485:2018 UNE
Status: Vigente/ 2018-07-25
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
UNE-EN 301489-29 V2.1.1 UNE
Status: Vigente/ 2017-02-01
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 29: Specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in February of 2017.)
UNE-EN 301489-27 V2.1.1 UNE
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in February of 2017.)
UNE-EN 301489-31 V2.1.1 UNE
Status: Vigente/ 2017-01-01
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements of article 3.1(b) of the Directive 2014/53/EU (Endorsed by Asociación Española de Normalización in January of 2017.)
