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UNE-EN ISO 14155:2021/A11:2025  UNE

Status: Vigente/ 2025-11-12

Clinical investigation of medical devices for human subjects - Good clinical practice

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 ISO 16571:2024  UNE

Status: Vigente/ 2024-11-27

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)

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 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 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 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 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

Status: Vigente/ 2020-11-11

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

UNE-EN ISO 14971:2020  UNE

Status: Vigente/ 2020-09-23

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

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 ISO 13485:2016/AC:2017  UNE

Status: Anulada/ 2018-07-25

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

UNE-EN ISO 15223-1:2017  UNE

Status: Anulada/ 2022-03-16

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

UNE-EN ISO 15225:2016  UNE

Status: Anulada/ 2018-02-08

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

UNE-EN ISO 13485:2016  UNE

Status: Anulada/ 2018-07-25

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

UNE-EN ISO 15378:2016  UNE

Status: Anulada/ 2018-10-24

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)

UNE-EN 62304:2007/A1:2016  UNE

Status: Vigente/ 2016-04-13

Medical device software - Software life-cycle processes

UNE-EN 62366:2009/A1:2015  UNE

Status: Anulada/ 2018-04-01

Medical devices - Application of usability engineering to medical devices

UNE-EN 60601-1-6:2010/A1:2015  UNE

Status: Vigente/ 2015-07-29

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

UNE-EN 13718-2:2015  UNE

Status: Anulada/ 2020-11-11

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

UNE-EN 60601-1-10:2008/A1:2015  UNE

Status: Vigente/ 2015-07-15

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

UNE-EN 60601-1:2008/A12:2015  UNE

Status: Vigente/ 2015-06-24

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

UNE-EN 13718-1:2015  UNE

Status: Anulada/ 2020-11-11

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

UNE-EN 62353:2015  UNE

Status: Vigente/ 2015-04-01

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

UNE-EN 60601-1-8:2008/A1:2013/AC:2014  UNE

Status: Vigente/ 2014-06-25

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

UNE-EN 60601-1:2008/AC:2014  UNE

Status: Anulada/ 2014-11-13

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

UNE-EN 1041:2009+A1:2014  UNE

Status: Anulada/ 2022-06-09

Information supplied by the manufacturer of medical devices

UNE-EN 60601-1-9:2008/A1:2013  UNE

Status: Vigente/ 2013-12-23

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

UNE-EN 60601-1-8:2008/A1:2013  UNE

Status: Vigente/ 2013-10-02

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

UNE-EN ISO 13485:2013  UNE

Status: Anulada/ 2019-04-01

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

UNE-EN ISO 15223-1:2013  UNE

Status: Anulada/ 2017-03-29

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

UNE-EN ISO 14971:2012  UNE

Status: Anulada/ 2020-09-23

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

UNE-EN 80001-1:2012  UNE

Status: Anulada/ 2024-10-27

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

UNE-EN ISO 13485:2012  UNE

Status: Anulada/ 2013-05-29

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

UNE-EN ISO 15378:2012  UNE

Status: Anulada/ 2016-05-11

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)

UNE-EN ISO 14155:2012  UNE

Status: Anulada/ 2021-09-22

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

UNE-EN 60601-1:2008/A11:2012  UNE

Status: Anulada/ 2018-12-25

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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 ISO 14155:2011  UNE

Status: Anulada/ 2012-02-22

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

UNE-EN 60601-1-6:2010  UNE

Status: Vigente/ 2010-11-10

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

UNE-EN ISO 15225:2010  UNE

Status: Anulada/ 2016-11-16

Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)

UNE-EN 80601-2-59:2010  UNE

Status: Anulada/ 2022-10-12

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

UNE-EN ISO 10993-16:2010  UNE

Status: Anulada/ 2018-05-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

UNE-EN 60601-1-6:2008 CORR:2010  UNE

Status: Anulada/ 2013-04-01

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

UNE-EN 60601-1-2:2008 CORR:2010  UNE

Status: Anulada/ 2019-01-01

Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

UNE-EN 60601-1-8:2008 CORR:2010  UNE

Status: Vigente/ 2010-06-16

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

UNE-EN 60601-1:2008 CORR:2010  UNE

Status: Vigente/ 2010-06-16

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance