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Number of results 257

UNE-EN ISO 15223-1:2017  UNE

Status: In force / 2017-05-24

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 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 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 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 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 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 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 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 60601-1:2008  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 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 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 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 60601-1-6:2010/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 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 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 60601-1-8:2008/A1:2013  UNE

Status: In force / 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

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 60601-1-8:2008  UNE

Status: In force / 2008-09-10

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 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 60601-1-8:2008/A1:2013/AC:2014  UNE

Status: In force / 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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

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 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 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 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 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-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 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 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-EN 60601-1-9:2008/A1:2013  UNE

Status: In force / 2013-12-23

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-2-22:2013  UNE

Status: In force / 2013-04-01

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (Endorsed by AENOR in April of 2013.)

CTN 209/SC 76 LASER AND ELECTRO-OPTICAL EQUIPMENTS, INSTALLATIONS AND SYSTEMS

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 60601-1-9:2008  UNE

Status: In force / 2008-12-03

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

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN 60601-1-10:2008  UNE

Status: In force / 2008-12-03

Medical electrical equipment- Part 1-10: General requirements for basic safety and essential performance- Collateral Satandard: Requirements for the development of physiologic closed-loop controllers

CTN 209/SC 62 ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

UNE-EN ISO 10993-2:2007  UNE

Status: In force / 2007-05-16

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)

CTN 111 SURGICAL AND MEDICAL DEVICES

UNE 20611:1979  UNE

Status: In force / 1979-04-15

BASICS ASPECTS OF THE SAFETY PHILOSOPHY OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE

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

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

Number of results 257