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UNE-EN ISO 15223-1:2017  UNE

Status: In force / 2019-12-18

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)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 14971:2012  UNE

Status: In force / 2012-11-28

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

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 62366-1:2015  UNE

Status: In force / 2015-06-01

Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in June of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 62366-1:2015/AC:2015  UNE

Status: In force / 2016-02-01

Medical devices - Part 1: Application of usability engineering to medical devices (Endorsed by AENOR in February of 2016.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 62304:2007/A1:2016  UNE

Status: In force / 2016-04-13

Medical device software - Software life-cycle processes

CTN 209/SC 62A ASPECTOS GENERALES DE LOS EQUIPOS ELÉCTRICOS UTILIZADOS EN LA PRÁCTICA MÉDICA

UNE-EN 60601-1-2:2015  UNE

Status: In force / 2015-11-01

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Endorsed by AENOR in November of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN ISO 14155:2012  UNE

Status: In force / 2012-02-22

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

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 62304:2007  UNE

Status: In force / 2007-03-28

Medical device software - Software life-cycle processes (IEC 62304:2006)

CTN 209/SC 62A ASPECTOS GENERALES DE LOS EQUIPOS ELÉCTRICOS UTILIZADOS EN LA PRÁCTICA MÉDICA

UNE-EN 62353:2015  UNE

Status: In force / 2015-04-01

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1:2008/A12:2015  UNE

Status: In force / 2015-06-24

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 1041:2009+A1:2014  UNE

Status: In force / 2014-03-05

Information supplied by the manufacturer of medical devices

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 60601-1:2006/A1:2013  UNE

Status: In force / 2013-11-01

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Endorsed by AENOR in November of 2013.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN ISO 10993-7:2009  UNE

Status: In force / 2009-06-03

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 62304:2007 CORR:2009  UNE

Status: In force / 2009-02-18

Medical device software - Software life-cycle processes

CTN 209/SC 62A ASPECTOS GENERALES DE LOS EQUIPOS ELÉCTRICOS UTILIZADOS EN LA PRÁCTICA MÉDICA

UNE-EN 60601-1-8:2007/A11:2017  UNE

Status: In force / 2017-04-01

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.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1-6:2010/A1:2015  UNE

Status: In force / 2015-07-29

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1-11:2015  UNE

Status: In force / 2015-07-01

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 AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1:2008  UNE

Status: In force / 2013-09-11

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 13718-2:2015  UNE

Status: In force / 2015-07-15

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

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 13718-1:2015  UNE

Status: In force / 2015-04-22

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

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 60601-1-6:2010  UNE

Status: In force / 2010-11-10

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1:2008 CORR:2010  UNE

Status: In force / 2010-06-16

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN ISO 10993-7:2009/AC:2010  UNE

Status: In force / 2010-02-24

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 60601-1:2008 ERRATUM:2008  UNE

Status: In force / 2008-11-26

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE 209001:2002 IN  UNE

Status: In force / 2002-05-30

Guide for the management and the maintenance of active non implantable medical devices.

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 80601-2-30:2010/A1:2015  UNE

Status: In force / 2015-07-01

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Endorsed by AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 80001-1:2012  UNE

Status: In force / 2012-10-10

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 15986:2011  UNE

Status: In force / 2011-10-26

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 80601-2-30:2010  UNE

Status: In force / 2010-11-01

Medical electrical equipment -- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (Endorsed by AENOR in November of 2010.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1-8:2008 CORR:2010  UNE

Status: In force / 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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN IEC 80601-2-59:2019  UNE

Status: In force / 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.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN IEC 80601-2-30:2019  UNE

Status: In force / 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.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 301489-31 V2.2.1  UNE

Status: In force / 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.)

CTN 133 TELECOMMUNICATIONS

UNE-EN 301489-29 V2.2.1  UNE

Status: In force / 2019-06-01

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 June of 2019.)

CTN 133 TELECOMMUNICATIONS

UNE-EN 301489-27 V2.2.1  UNE

Status: In force / 2019-06-01

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.)

CTN 133 TELECOMMUNICATIONS

UNE-EN ISO 10993-11:2018  UNE

Status: In force / 2018-12-26

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 15378:2018  UNE

Status: In force / 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)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 13485:2018  UNE

Status: In force / 2018-07-25

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

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN ISO 10993-16:2018  UNE

Status: In force / 2018-05-16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE-EN 301489-29 V2.1.1  UNE

Status: In force / 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.)

CTN 133 TELECOMMUNICATIONS

UNE-EN 301489-27 V2.1.1  UNE

Status: In force / 2017-02-01

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.)

CTN 133 TELECOMMUNICATIONS

UNE-EN 301489-31 V2.1.1  UNE

Status: In force / 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.)

CTN 133 TELECOMMUNICATIONS

UNE-EN 80601-2-35:2009/A1:2016  UNE

Status: In force / 2017-01-01

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 January of 2017.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1-10:2008/A1:2015  UNE

Status: In force / 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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-2-62:2015  UNE

Status: In force / 2015-07-01

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment (Endorsed by AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1-12:2015  UNE

Status: In force / 2015-07-01

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 AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-2-36:2015  UNE

Status: In force / 2015-07-01

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy (Endorsed by AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 80601-2-60:2015  UNE

Status: In force / 2015-07-01

Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (Endorsed by AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 45502-1:2015  UNE

Status: In force / 2015-07-01

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (Endorsed by AENOR in July of 2015.)

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-CEN/CLC/TR 14060:2014  UNE

Status: In force / 2015-04-01

Medical device traceability enabled by unique device identification (UDI) (Endorsed by AENOR in April of 2015.)

CTN 111 SURGICAL AND MEDICAL DEVICES

Number of results 243

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