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 2018-11-22

Référence, Titre
Downloads

Date de

Circulation

Date de

Fermeture

CENELEC

Votes /

Commentaires

Aux comités

Authorisés

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
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
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
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1342A/DA

[Revised draft agenda for the meeting to be held in Shanghai, China on 2019-10-22 (starting time: 14:00 to approximate finishing time: 17:00)]

Titre français non disponible

2019-09-20 N/A
62A/1361/INF

[Report of the Secretariat (Agenda item 5.1)]

Titre français non disponible

2019-09-20 N/A
62A/1362/INF

[Confirmation of working group conveners (Agenda Item 5.2)]

Titre français non disponible

2019-09-20 N/A
62A/1363/INF

[Reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A for the October 2019 Subcommittee in Shanghai, China (Agenda item 5.3)]

Titre français non disponible

2019-09-20 N/A
62A/1364/INF

[Status report on the development/finalization of the Amendment projects (Agenda item 6.1)]

Titre français non disponible

2019-09-20 N/A
62A/1365/INF

[Report of voting on the CDV/DIS stage for the Amendment projects (Agenda item 6.2)]

Titre français non disponible

2019-09-20 N/A
62A/1366/INF

[Secretariat’s view of the programme of work of the subcommittee (Agenda item 7.1)]

Titre français non disponible

2019-09-20 N/A
62A/1367/INF

[Maintenance Cycle (Agenda item 7.2)]

Titre français non disponible

2019-09-20 N/A
62A/1368/INF

[IEC/SC 62A Liaison Reports for the October meeting 2019 of the Subcommittee in Shanghai, China (Agenda item 8.1)]

Titre français non disponible

2019-09-20 N/A
62A/1369/INF

[Subcommittee 62A Liaison List (Agenda item 8.2)]

Titre français non disponible

2019-09-20 N/A
62A/1353/RVC

[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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1354/RVC

[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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1355/RVC

[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

2019-09-13 Y
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1356/RVC

[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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1357/RVC

[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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1358/RVC

[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

2019-09-13 Y
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/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

2019-09-13 2019-11-08 Y Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
62A/1352/INF

[Review of Active Participation of P-members in the Work of SC 62A]

Titre français non disponible

2019-09-06 N/A
62A/1315B/CC

[Compilation of Comments on 62A/1302/CD - 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

2019-08-30 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/1317A/CC

[Compilation of Comments on 62A/1308/CD - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2019-08-30 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/1350/RVC

[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

2019-08-30 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1351/RVC

[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

2019-08-30 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1315A/CC

[Compilation of Comments on 62A/1302/CD - 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

2019-08-16 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/1348/Q

[Questionnaire: National Committee feedback needed regarding proposed CEN lead on 62A/1343/NP Health software – Part 2: Health and wellness apps – Quality criteria across the life cycle – Code of practice]

Titre français non disponible

2019-08-09 2019-09-20 N/A Report of Comments
62A/1309A/RVC

[Result of Voting on 62A/1288/CDV - IEC 62366-1/AMD1 ED1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible

2019-07-19 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/1346/Q

[National Committee feedback needed regarding possible new work - Of Interest to IEC/SC 62A - Safety of intended performances]

Titre français non disponible

2019-07-19 2019-08-30 N/A Report of Comments
62A/1347/INF

[Information about the attached Document (62/333/DC) for comments on architecture aspects of safety standards for medical electrical equipment, medical electrical systems, and software used in healthcare]

Titre français non disponible

2019-07-19 N/A
62A/1345/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

2019-07-12 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/1319A/CC

[Compilation of Comments on 62A/1310/CD - IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2019-07-05 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
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

2019-07-05 2019-09-27 N Voting Result
62A/1344/RVD

[Result of Voting on 62A/1330/FDIS - ISO 14971 ED3: Medical devices - Application of risk management to medical devices]

Titre français non disponible

2019-07-05 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/1342/DA

[Draft agenda for the meeting to be held in Shanghai, China on 2019-10-22 (starting time: 14:00 to approximate finishing time: 17:00)]

Titre français non disponible

2019-06-21 N/A
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

2019-06-07 2019-09-27 N Report of Comments
62A/1164C/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

2019-05-24 N/A
62A/1166D/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

2019-05-24 N/A
62A/1168B/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

2019-05-24 N/A
62A/1170D/INF

[Updated 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

2019-05-24 N/A
62A/1172C/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

2019-05-24 N/A
62A/1174C/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

2019-05-24 N/A
62A/1320/CDV

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

2019-05-24 2019-08-16 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/1321/CDV

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

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1324/CDV

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

2019-05-24 2019-08-16 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/1325/CDV

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

2019-05-24 2019-08-16 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/1326/CDV

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

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1327/CDV

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

2019-05-24 2019-08-16 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/1328/CDV

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

2019-05-24 2019-08-16 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/1329/CDV

IEC 60601-1-12/AMD1 ED1: 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

2019-05-24 2019-08-16 Y Voting Result
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/1333/INF

[Informative document- Working draft of IEC 60601-1 Ed.3.2: Medical electrical equipment – Part 1: General requirements for safety and essential performance - Companion document to 62A/1320/CDV]

Titre français non disponible

2019-05-24 N/A
62A/1334/INF

[Informative document - Working draft of IEC 60601-2 Ed.4.1: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests - Companion document to 62A/1321/CDV]

Titre français non disponible

2019-05-24 N/A
62A/1335/INF

[Informative document - Working draft of IEC 60601-1-6 Ed.3.2: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability - Companion document to 62A/1324/CDV]

Titre français non disponible

2019-05-24 N/A
62A/1336/INF

[Informative document - Working draft of IEC 60601-1-8 Ed.2.2: 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 - Companion document 62A/1325/CDV]

Titre français non disponible

2019-05-24 N/A
62A/1337/INF

[Informative document - Working Draft of IEC 60601-1-9 Ed.1.2: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design - Companion document to 62A/1326/CDV]

Titre français non disponible

2019-05-24 N/A
62A/1338/INF

[Informative document - Working Draft of IEC 60601-1-10 Ed.1.2. 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 - Companion document to 62A/1327/CDV]

Titre français non disponible

2019-05-24 N/A
62A/1339/INF

[Informative document - Working Draft of IEC 60601-1-11 Ed.2.1: 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 - Companion document to 62A/1328/CDV ]

Titre français non disponible

2019-05-24 N/A
62A/1340/INF

[Informative document - working Draft of IEC 60601-1-12 Ed.1.1: 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 - Companion document to 62A/1329/CDV]

Titre français non disponible

2019-05-24 N/A
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

2019-05-17 2019-08-09 Y Report of Comments
TC 56
SC 62B
SC 62C
SC 62D
62A/1330/FDIS

ISO 14971 ED3: Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux

2019-05-10 2019-06-21 E Voting Result
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/1331/DTR

ISO TR 24971 ED2: Dispositifs·médicaux — Directives relatives à l'ISO 14971

2019-05-10 2019-07-05 E Voting Result
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/1297A/CC

[Compilation of Comments on 62A/1284/CD - ISO TR 24971 ED2: Medical devices -- Guidance on the application of ISO 14971]

Titre français non disponible

2019-04-26 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/1311A/CC

[Compilation of Comments on 62A/1298/CD - 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

2019-04-05 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1322/RR

Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable

2019-04-05 Y
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1323/RR

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

2019-04-05 Y
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/1279A/CC

[Compilation of Comments on 62A/1268/CD - 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

2019-03-29 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1314A/CC

[Compilation of Comments on 62A/1303/CD - 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

2019-03-29 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1318/INF

[Results of the National Committee Enquiry in roposal from the Ad Hoc Group 62368-60601 on integration of the requirements of IEC 62368-1:2018 as an alternative approach to demonstrating MEANS OF OPERATOR PROTECTION - "Application of this standard on the incorporation of equipment complying with IEC 62368-1:2018 into ME EQUIPMENT and ME SYSTEMS"]

Titre français non disponible

2019-03-22 N/A
62A/1319/CC

[Compilation of Comments on 62A/1310/CD - IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2019-03-22 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1317/CC

[Compilation of Comments on 62A/1308/CD - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2019-03-15 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/1290A/RVN

[Result of Voting on 62A/1277/NP - PNW 62A-1277: Application of risk management for IT-networks incorporating medical device – Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 5-1: Activities in the product lifecycle]

Titre français non disponible

2019-03-01 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1316/RQ

[Result of Questionnaire on 62A/1306/Q: Nomination of convenor of IEC/SC 62A/MT 28, Electrical hazards]

Titre français non disponible

2019-03-01 N/A
62A/1296A/RVC

[Result of Voting on 62A/1282/CDV - ISO 14971 ED3: Medical devices - Application of risk management to medical devices]

Titre français non disponible

2019-02-22 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/1315/CC

[Compilation of Comments on 62A/1302/CD - 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

2019-02-22 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/1224A/CC

[Compilation of Comments on 62A/1204/CD - 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

2019-02-15 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1262A/CC

[Compilation of Comments on 62A/1239/CD - 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

2019-02-15 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1314/CC

[Compilation of Comments on 62A/1303/CD - 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

2019-02-08 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1313/INF

[Result of ISO/IEC Guide 63 vote– Of Interest to IEC/SC 62A - Guide to the development and inclusion of aspects of safety in International Standards for medical devices]

Titre français non disponible

2019-02-01 N/A
62A/1305A/RQ

[Revised result of Questionnaire on 62A/1300/Q: Questionnaire on NC feedback needed regarding risk management process in the revision of IEC 62304, Health software – Software life cycle processes]

Titre français non disponible

2019-01-25 N/A
62A/1311/CC

[Compilation of Comments on 62A/1298/CD - 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

2019-01-25 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1312/INF

[ISO/TC 210 Draft Standard – Of Interest to IEC/SC 62A - ISO 20417: Medical devices – Requirements for general information to be provided by the manufacturer]

Titre français non disponible

2019-01-25 N/A
62A/1310/CD

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

2019-01-18 2019-03-15 Y Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1276A/RVC

[Result of Voting on 62A/1235/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2019-01-11 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1292A/CC

[Compilation of Comments on 62A/1283/CD - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2019-01-11 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/1305/RQ

[Result of Questionnaire on 62A/1300/Q: Questionnaire on NC feedback needed regarding risk management process in the revision of IEC 62304, Health software – Software life cycle processes]

Titre français non disponible

2019-01-11 N/A
62A/1306/Q

[Nomination of convenor of IEC/SC 62A/MT 28, Electrical hazards]

Titre français non disponible

2019-01-11 2019-02-22 N/A Report of Comments
62A/1307/INF

[National Committees of SC 62A input needed on IEC 62B/1116/CDV – IEC 63077 Ed. 1: Good refurbishment practices for medical imaging]

Titre français non disponible

2019-01-11 N/A
62A/1308/CD

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

Titre français non disponible

2019-01-11 2019-03-08 E Report of Comments
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/1309/RVC

[Result of Voting on 62A/1288/CDV - IEC 62366-1/AMD1 ED1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible

2019-01-11 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/1170C/INF

[Updated 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]

Titre français non disponible

2018-12-14 N/A
62A/1303/CD

[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

2018-12-07 2019-02-01 Y Report of Comments
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1304/INF

[Informative document - Working Draft of IEC 60601-1-8 Ed. 2.2 - 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 - Companion document to 62A/1303/CD]

Titre français non disponible

2018-12-07 N/A
62A/1264A/CC

[Compilation of Comments on 62A/1241/CD - 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

2018-11-30 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1302/CD

[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

2018-11-23 2019-02-15 Y Report of Comments
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