International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62A

Aspects généraux des équipements électriques utilisés en pratique médicale

 
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SC 62A Document de Travail depuis 2019-09-23

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Date de

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Date de

Fermeture

CENELEC

Votes /

Commentaires

Aux comités

Authorisés

62A/1417/RVDTR

[Result of Voting on 62A/1402/DTR - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices]

Titre français non disponible

2020-08-28 N
62A/1418/RQ

[Result of Questionnaire on 62A/1412/Q: National Committee feedback needed on proposed renumbering and updated title for international standard on security activities in the health software life cycle (IEC 80001-5-1 to IEC 81001-5-1)]

Titre français non disponible

2020-08-28 N/A
62A/1383B/RVC

[Revised Result of Voting on 62A/1349/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2020-08-14 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1414/RVDISH

[Result of Voting on 62A/1403/DISH - IEC 60601-1/AMD1/ISH1 ED3: Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance]

Titre français non disponible

2020-08-14 E
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1415/INF

[Call for experts to Working Group TC 62/WG 4 Terminology]

Titre français non disponible

2020-08-14 N/A
62A/1416/INF

[Nominations to the Software Network and Artificial Intelligence Advisory Group (AG SNAIG) of TC 62]

Titre français non disponible

2020-08-14 N/A
62A/1413/INF

[IEC TC 62/ISO TC 210 Joint Advisory Group on Life Cycle Aspects for Medical Devices]

Titre français non disponible

2020-08-07 N/A
62A/1383A/RVC

[Revised Result of Voting on 62A/1349/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2020-07-24 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1385A/RVC

[Revised Result of Voting on 62A/1370/CDV - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2020-07-10 E
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1412/Q

[Questionnaire - National Committee feedback needed on proposed renumbering and updated title for international standard on security activities in the health software life cycle (IEC 80001-5-1 to IEC 81001-5-1)]

Titre français non disponible

2020-07-10 2020-08-21 N/A Report of Comments
62A/1404/RVD

[Result of Voting on 62A/1389/FDIS - IEC 60601-1/AMD2 ED3: Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance]

Titre français non disponible

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1405/RVD

[Result of Voting on 62A/1390/FDIS - IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests]

Titre français non disponible

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1406/RVD

[Result of Voting on 62A/1391/FDIS - IEC 60601-1-6/AMD2 ED3: Amendment 2 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability]

Titre français non disponible

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1407/RVD

[Result of Voting on 62A/1392/FDIS - IEC 60601-1-8/AMD2 ED2: Amendment 2 – 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]

Titre français non disponible

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1408/RVD

[Result of Voting on 62A/1393/FDIS - IEC 60601-1-9/AMD2 ED1: Amendment 2 - Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design]

Titre français non disponible

2020-06-26 Y
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1409/RVD

[Result of Voting on 62A/1394/FDIS - IEC 60601-1-10/AMD2 ED1: Amendment 2 – 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]

Titre français non disponible

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1410/RVD

[Result of Voting on 62A/1395/FDIS - IEC 60601-1-11/AMD1 ED2: Amendment 1 – 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]

Titre français non disponible

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1411/RVD

[Result of Voting on 62A/1396/FDIS - IEC 60601-1-12/AMD1 ED1: Amendment 1 - 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]

Titre français non disponible

2020-06-26 Y
ACEA
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1402/DTR

[IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices]

Titre français non disponible

2020-06-19 2020-08-14 N Voting Result
62A/1403/DISH

IEC 60601-1/AMD1/ISH1 ED3: Feuille d'interprétation 1 - Amendement 1 - Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

2020-06-19 2020-07-31 E Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1400A/CC

[Revised Compilation of Comments on 62A/1384/CD - IEC 80001-5-1 ED1: Safety, security and effectiveness in the implementation and use of connected medical devices or connected health software - Part 5-1: Security - Activities in the product lifecycle]

Titre français non disponible

2020-06-12 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1387A/CC

[Revised Compilation of Comments on 62A/1380/CD - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices]

Titre français non disponible

2020-05-15 N
62A/1391(F)/FDIS

IEC 60601-1-6/AMD2 ED3: Amendement 2 - Appareils électromédicaux - Partie 1-6 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : aptitude à l'utilisation

2020-05-15 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1393(F)/FDIS

IEC 60601-1-9/AMD2 ED1: Amendement 2 - Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable

2020-05-15 Y
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1395(F)/FDIS

IEC 60601-1-11/AMD1 ED2: Amendement 1 - Appareils électromédicaux - Partie 1-11 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

2020-05-15 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1399/RVC

[Result of Voting on 62A/1379/CDV - IEC 63120 ED1: Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle]

Titre français non disponible

2020-05-15 Y
TC 56
SC 62B
SC 62C
SC 62D
62A/1400/CC

[Compilation of Comments on 62A/1384/CD - IEC 80001-5-1 ED1: Safety, security and effectiveness in the implementation and use of connected medical devices or connected health software - Part 5-1: Security - Activities in the product lifecycle]

Titre français non disponible

2020-05-15 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1401/DC

[Document for comments: National Committee feedback needed on IEC 63120 - Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle]

Titre français non disponible

2020-05-15 2020-06-26 N/A Report of Comments
62A/1394(F)/FDIS

IEC 60601-1-10/AMD2 ED1: Amendement 2 - Appareils électromédicaux - Partie 1-10 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Exigences pour le développement des régulateurs physiologiques en boucle fermée

2020-05-08 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1396(F)/FDIS

IEC 60601-1-12/AMD1 ED1: Amendement 1 - Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

2020-05-08 Y
ACEA
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1397/RVD

[Result of Voting on 62A/1386/FDIS - IEC 62366-1/AMD1 ED1: Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible

2020-05-08 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1398/RVC

[Result of Voting on 62A/1359/CDV - IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management]

Titre français non disponible

2020-05-01 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1164D/INF

[Design Specification for Amendment 2 to IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Revision 3))]

Titre français non disponible

2020-04-24 N/A
62A/1166E/INF

[Design Specification for Amendment 1 to IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests (Revision 4)]

Titre français non disponible

2020-04-24 N/A
62A/1168C/INF

[Design Specification for Amendment 2 to IEC 60601-1-6:2010 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (Revision 2)]

Titre français non disponible

2020-04-24 N/A
62A/1170E/INF

[Design Specification for Amendment 2 to IEC 60601-1-8:2006 - 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 (Revision 4)]

Titre français non disponible

2020-04-24 N/A
62A/1172D/INF

[Design Specification for Amendment 2 to IEC 60601-1-10:2007 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 (Revision 3)]

Titre français non disponible

2020-04-24 N/A
62A/1174D/INF

[Design Specification for Amendment 1 to IEC 60601-1-11:2015 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 (Revision 3)]

Titre français non disponible

2020-04-24 N/A
62A/1389/FDIS

IEC 60601-1/AMD2 ED3: Amendement 2 - Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1390/FDIS

IEC 60601-1-2/AMD1 ED4: Amendement 1 -Appareils électromédicaux - Partie 1-2 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Perturbations électromagnétiques - Exigences et essais

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1391/FDIS

IEC 60601-1-6/AMD2 ED3: Amendement 2 - Appareils électromédicaux - Partie 1-6 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : aptitude à l'utilisation

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1392/FDIS

IEC 60601-1-8/AMD2 ED2: Amendement 2 - Appareils électromédicaux - Partie 1-8 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1393/FDIS

IEC 60601-1-9/AMD2 ED1: Amendement 2 - Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable

2020-04-24 2020-06-05 Y Voting Result
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1394/FDIS

IEC 60601-1-10/AMD2 ED1: Amendement 2 - Appareils électromédicaux - Partie 1-10 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour le développement des régulateurs physiologiques en boucle fermée

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1395/FDIS

IEC 60601-1-11/AMD1 ED2: Amendement 1 - Appareils électromédicaux - Partie 1-11 : exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1396/FDIS

IEC 60601-1-12/AMD1 ED1: Amendement 1 - Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

2020-04-24 2020-06-05 Y Voting Result
ACEA
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1388/INF

[ISO/TC 210 New Work Item Proposal - For Information. Proposal for a new Standard, Active medical device – Good engineering maintenance management]

Titre français non disponible

2020-04-03 N/A
62A/1387/CC

[Compilation of Comments on 62A/1380/CD - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices]

Titre français non disponible

2020-03-13 N
62A/1386/FDIS

IEC 62366-1/AMD1 ED1: Amendement 1 - Dispositifs médicaux - Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

2020-02-28 2020-04-10 Y Voting Result
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1385/RVC

[Result of Voting on 62A/1370/CDV - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2020-02-21 E
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1375A/CC

[Revised Compilation of Comments on 62A/1360/CD - IEC 80001-5-1 ED1: Safety, security and effectiveness in the implementation and use of connected medical devices or connected health software - Part 5-1: Security - Activities in the product lifecycle]

Titre français non disponible

2020-01-31 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1379/CDV

IEC 63120 ED1: Reconditionnement des appareils électromédicaux, des systèmes et sous-ensembles électromédicaux et réutilisation des composants dans le cadre du cycle de vie étendu

2020-01-31 2020-04-24 Y Voting Result
TC 56
SC 62B
SC 62C
SC 62D
62A/1383/RVC

[Result of Voting on 62A/1349/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2020-01-31 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1384/CD

[IEC 80001-5-1 ED1: Safety, security and effectiveness in the implementation and use of connected medical devices or connected health software - Part 5-1: Security - Activities in the product lifecycle]

Titre français non disponible

2020-01-31 2020-04-24 Y Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
62A/1350A/RVC

[Revised Result of Voting on 62A/1320/CDV - IEC 60601-1/AMD2 ED3: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance]

Titre français non disponible

2020-01-24 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1351A/RVC

[Revised Result of Voting on 62A/1321/CDV - IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.]

Titre français non disponible

2020-01-24 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1353A/RVC

[Revised Result of Voting on 62A/1324/CDV - IEC 60601-1-6/AMD2 ED3: Amendment 2 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability]

Titre français non disponible

2020-01-24 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1354A/RVC

[Revised Result of Voting on 62A/1325/CDV - IEC 60601-1-8/AMD2 ED2: Amendment 2 – 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]

Titre français non disponible

2020-01-24 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1355A/RVC

[Revised Result of Voting on 62A/1326/CDV - IEC 60601-1-9/AMD2 ED1: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design]

Titre français non disponible

2020-01-24 Y
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1356A/RVC

[Revised Result of Voting on 62A/1327/CDV - IEC 60601-1-10/AMD2 ED1: Amendment 2 – 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]

Titre français non disponible

2020-01-24 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1357A/RVC

[Revised Result of Voting on 62A/1328/CDV - IEC 60601-1-11/AMD1 ED2: Amendment 1 – 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]

Titre français non disponible

2020-01-24 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1358A/RVC

[Revised Result of Voting on 62A/1329/CDV - IEC 60601-1-12/AMD1 ED1: 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]

Titre français non disponible

2020-01-24 Y
ACEA
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1381/RQ

[Result of Questionnaire on 62A/1346/Q: National Committee feedback needed regarding possible new work – Of interest to IEC/SC 62A – Safety of intended performances ]

Titre français non disponible

2019-12-20 N/A
62A/1382/AC

[ahG 34: Ad hoc group to investigate single fault safety for 60601-1 - Call for experts]

Titre français non disponible

2019-12-20 N/A
62A/1345A/RVDTR

[Result of Voting on 62A/1331/DTR - ISO TR 24971 ED2: Medical devices -- Guidance on the application of ISO 14971]

Titre français non disponible

2019-12-13 E
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1376/CC

[Compilation of Comments on 62A/1332/CD - IEC 63120 ED1: Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle]

Titre français non disponible

2019-12-13 Y
TC 56
SC 62B
SC 62C
SC 62D
62A/1377/CC

[Compilation of Comments on 62A/1341/CD - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices]

Titre français non disponible

2019-12-13 N
62A/1378/DC

[Document for Comment Proposal for a new Technical Report in the IEC 60601 series - Medical Electrical Equipment - Part 4-X: Voluntary guidance on achieving basic safety and essential performance with regard to electromagnetic disturbances]

Titre français non disponible

2019-12-13 2020-01-24 N/A Report of Comments
62A/1380/CD

[IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices]

Titre français non disponible

2019-12-13 2020-03-06 N Report of Comments
62A/1375/CC

[Compilation of Comments on 62A/1360/CD - IEC 80001-5-1 ED1: Safety, security and effectiveness in the implementation and use of connected medical devices or connected health software - Part 5-1: Security - Activities in the product lifecycle]

Titre français non disponible

2019-12-06 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1372/RM

[Unconfirmed minutes of the meeting held in Shanghai, China on 22 October 2019]

Titre français non disponible

2019-11-29 N/A
62A/1373/MTG

[Meeting documents - Plenary meeting held in Shanghai, China on 22 October 2019]

Titre français non disponible

2019-11-29 N/A
62A/1374/RVN

[Result of Voting on 62A/1343/NP - PNW TS 62A-1343: Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice]

Titre français non disponible

2019-11-29 N
62A/1370/CDV

[ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2019-11-15 2020-02-07 E Voting Result
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1359/CDV

IEC 80001-1 ED2: Sécurité, efficacité et sureté dans la mise en œuvre et l’utilisation des dispositifs médicaux connectés ou des logiciels de santé connectés - Partie 1 : Application de la gestion des risques

2019-11-01 2020-01-24 Y Voting Result
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1371/DL

[List of decisions taken at the meeting of SC 62A, held in Shanghai, China on 22 October 2019]

Titre français non disponible

2019-11-01 N/A
62A/1349/CDV

IEC 62304 ED2: Logiciels de santé – Processus du cycle de vie du logiciel

2019-10-04 2019-12-27 Y Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108