SC 62A |
Aspects généraux des équipements électriques utilisés en pratique médicale |
SC 62A Document de Travail depuis 2020-04-17
Référence, Titre
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Downloads
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Date de Circulation |
Date de Fermeture |
CENELEC
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Votes / Commentaires |
Aux comit?s Authoris?s |
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62A/1448/RVD
[Result of Voting on 62A/1434/FDIS - 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
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2021-04-16 | 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
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|||
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62A/1449/RVC
[Result of Voting on 62A/1419/CDV - IEC 81001-5-1 ED1: Health Software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle]
Titre français non disponible
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2021-04-16 | Y |
TC 62
SC 62B
SC 62C
SC 62D
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62A/1430A/DA
[Revised draft agenda for the meeting to be held virtually,from 2021-04-15 (starting time: 11:00 UTC) to (approximate finishing time: 14:00 UTC) - (11:00 UTC corresponds to 13:00 Central European time, 07:00 U.S. Eastern time and 20:00Japan time]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1441/INF
[Vice Chair reappointment (Agenda item 6.1)]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1442/INF
[Review of Active Participation of P-members in the Work of SC 62A]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1443/INF
[Confirmation of working group conveners (Agenda item 6.2)]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1444/INF
[Maintenance Cycle (Agenda Item 7)]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1445/INF
[Reports from the Working Groups, Maintenance Teams and Joint working Groups of IEC/SC 62A - For the April 2021 Subcommittee Meeting - Virtual (Agenda item 6.3)]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1446/INF
[IEC/SC 62A Liaison List and Reports for the April 2021 Subcommittee Meeting held virtually (Agenda item 9)]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1447/INF
[Result of 62A/1431/DC: Seeking 62A NC feedback on a DC circulated by IEC/TC 62 regarding a possible new sub-committee in TC 62]
Titre français non disponible
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2021-03-12 | N/A | ||||
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62A/1440/DTS
[ISO TS 82304-2 ED1: Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice]
Titre français non disponible
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2021-03-05 | 2021-05-28 | N | |||
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62A/1439/RQ
[Result of Questionnaire (62A/1425/Q): National Committee feedback needed on proposed Interpretation Sheet for clauses 4.3 and 4.7 in IEC 60601-1(Follow up to 62A/1403/DISH)]
Titre français non disponible
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2021-02-26 | N/A | ||||
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62A/1434/FDIS
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
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2021-02-12 | 2021-03-26 | 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
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62A/1435/RVD
[Result of Voting on 62A/1428/FDIS - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts]
Titre français non disponible
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2021-02-12 | 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
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62A/1436/RR
[Review of IEC TR 80001-2-8 ED1: Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2]
Titre français non disponible
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2021-02-12 | N |
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
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62A/1437/RR
[Review report of IEC TR 80001-2-2 ED1: Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls]
Titre français non disponible
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2021-02-12 | N | ||||
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62A/1438/DC
[Document for Comments: Revision to start: IEC 62366-2:2016, Medical devices - Part 2: Guidance on the application of usability engineering to medical devices]
Titre français non disponible
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2021-02-12 | 2021-04-09 | N/A | Report of Comments | ||
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62A/1432/INF
[Result of 62A/1426/DC on IEC 80001-2-8, Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 - Comments on proposed revision]
Titre français non disponible
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2021-01-15 | N/A | ||||
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62A/1433/INF
[Result of 62A/1427/DC on IEC 80001-2-2, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls – Comments on proposed revision]
Titre français non disponible
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2021-01-15 | N/A | ||||
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62A/1422(F)/CDV
IEC 62304 ED2: Logiciels de santé – Processus du cycle de vie du logiciel
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2021-01-08 | 2021-03-26 | Y | Voting Result |
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
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62A/1424/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
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2021-01-08 | 2021-04-02 | Y | Voting Result |
TC 56
SC 62B
SC 62C
SC 62D
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62A/1431/DC
[IEC 62/374/DC describing proposal for a new subcommittee in TC62 :Feedback from 62A P-members will be helpful for discussion at April plenary meeting]
Titre français non disponible
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2021-01-08 | 2021-02-19 | N/A | Report of Comments | ||
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62A/1422/CDV
IEC 62304 ED2: Logiciels de santé – Processus du cycle de vie du logiciel
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2021-01-01 | 2021-03-26 | Y | Voting Result |
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
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62A/1423A/INF
[Updated Information regarding the revision of IEC 62304, Health software – Software life cycle processes - IMPORTANT – Virtual Sessions to be held on 8 and 9 December 2020]
Titre français non disponible
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2020-12-18 | N/A | ||||
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62A/1428/FDIS
[ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts]
Titre français non disponible
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2020-12-18 | 2021-01-29 | 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
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62A/1430/DA
[Draft agenda for the meeting to be held virtually,from 2021-04-15 (starting time: 11:00 UTC) to (approximate finishing time: 14:00 UTC) - (11:00 UTC corresponds to 13:00 Central European time, 07:00 U.S. Eastern time and 20:00Japan time]
Titre français non disponible
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2020-12-18 | N/A | ||||
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62A/1429/NP
[PNW TS 62A-1429 ED1: Safe, effective, and secure health software and health IT systems - Assurance cases
Application guidance — Guidance for the use of assurance cases – safety & security] Titre français non disponible |
2020-12-04 | 2021-02-26 | U | Voting Result | ||
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62A/1398A/RVC
[Revised 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
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2020-11-27 | 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
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62A/1419/CDV
IEC 81001-5-1 ED1: Logiciels de santé et sécurité, efficacité et sûreté des systèmes TI de santé - Partie 5-1 : Sûreté - Activités du cycle de vie du produit
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2020-11-27 | 2021-02-19 | Y | Voting Result |
TC 62
SC 62B
SC 62C
SC 62D
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62A/1426/DC
[Document for comments: IEC TR 80001-2-8:2016Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 ]
Titre français non disponible
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2020-11-27 | 2021-01-08 | N/A | Report of Comments | ||
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62A/1427/DC
[Document for Comments - IEC TR 80001-2-2:2012Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls]
Titre français non disponible
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2020-11-27 | 2021-01-08 | N/A | Report of Comments | ||
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62A/1425/Q
[National Committee feedback needed on proposed Interpretation Sheet for clauses 4.3 and 4.7 in IEC 60601-1 - (Follow up to 62A/1403/DISH)]
Titre français non disponible
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2020-11-20 | 2021-01-08 | N/A | Report of Comments | ||
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62A/1399A/RVC
[Revised 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
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2020-11-13 | Y |
TC 56
SC 62B
SC 62C
SC 62D
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62A/1423/INF
[Information regarding the revision of IEC 62304, Health software – Software life cycle processes - IMPORTANT – Virtual Sessions to be held on 8 and 9 December 2020]
Titre français non disponible
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2020-11-13 | N/A | ||||
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62A/1374A/RVN
[Revised 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
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2020-10-30 | N | ||||
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62A/1420/INF
[Background information on IEC/ISO 81001-5-1 - “Security Activities in The Product Lifecycle”]
Titre français non disponible
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2020-10-30 | N/A | ||||
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62A/1421/INF
[Results on the Document for Comment (62A/1401/DC): 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
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2020-10-30 | N/A | ||||
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62A/1417A/RVDTR
[Revised 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
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2020-10-09 | N | ||||
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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
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2020-08-28 | N | ||||
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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
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2020-08-28 | N/A | ||||
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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
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2020-08-14 | Y |
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
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|||
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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
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2020-08-14 | E |
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
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|||
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62A/1415/INF
[Call for experts to Working Group TC 62/WG 4 Terminology]
Titre français non disponible
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2020-08-14 | N/A | ||||
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62A/1416/INF
[Nominations to the Software Network and Artificial Intelligence Advisory Group (AG SNAIG) of TC 62]
Titre français non disponible
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2020-08-14 | N/A | ||||
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62A/1413/INF
[IEC TC 62/ISO TC 210 Joint Advisory Group on Life Cycle Aspects for Medical Devices]
Titre français non disponible
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2020-08-07 | N/A | ||||
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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
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2020-07-24 | Y |
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
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|||
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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
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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
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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
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2020-07-10 | 2020-08-21 | N/A | Report of Comments | ||
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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
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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
|
|||
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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
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2020-06-26 | Y |
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
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|||
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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
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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
|
|||
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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
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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
|
|||
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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
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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
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|||
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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
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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
|
|||
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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
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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
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|||
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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
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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
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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
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2020-06-19 | 2020-08-14 | N | Voting Result | ||
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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
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2020-06-19 | 2020-07-31 | E | Voting Result |
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
|
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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
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2020-06-12 | Y |
TC 62
SC 62B
SC 62C
SC 62D
|
|||
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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 | Voting Result |
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
|
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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 | Voting Result |
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
|
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|
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 | Voting Result |
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
|
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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 | 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(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
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2020-05-08 | 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/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
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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
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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
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2020-04-24 | N/A | ||||
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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
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2020-04-24 | N/A | ||||
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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
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2020-04-24 | N/A | ||||
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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
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2020-04-24 | N/A | ||||
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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
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2020-04-24 | N/A | ||||
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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
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2020-04-24 | N/A | ||||
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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
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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
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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
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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
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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
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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
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|
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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
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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
|
|
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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
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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
|
|
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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
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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
|
|
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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
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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
|
|
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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
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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
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108 kB
2345 kB