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 2012-04-06

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62A/868A/INF

[Revised IEC/SC 62A Liaison reports - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 8.1)]

Titre français non disponible
2013-04-05
62A/850/CDV

CEI 60601-1-12: 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
2013-03-222013-06-28yes
TC 66
TC 76
62A/874/FDIS

Amendement 1 à la CEI 60601-1-9: Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable
2013-03-222013-05-24yes
TC 66
TC 76
62A/857B/RVC

[Revised result of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2013-03-22no
62A/873/RVN

[Result of voting on 62A/843/NP - ISO/TR 80001-2-6: Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements]

Titre français non disponible
2013-03-15?
62A/870/INF

[Secretariat's view of the programme of work of the subcommittee]

Titre français non disponible
2013-03-08
62A/871/PW

[Programme of work of the Subcommittee as recorded by the IEC Central Office in its database]

Titre français non disponible
2013-03-08
62A/872/CC

[Compilation of comments on 62A/844/CD - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible
2013-03-08yes
62A/849A/DA

[Revised draft agenda for the meeting to be held in Shanghai, China on 2013-04-17 (starting time: 09:00) to (approximate finishing time: 12:00) ]

Titre français non disponible
2013-03-08
62A/861/INF

[IEC/SC 62A Secretariat Plan for Updating the IEC 60601 Collateral Standards]

Titre français non disponible
2013-02-22
62A/862/INF

[Subcommittee 62A Liaison Liste (as for 2013-02-18)]

Titre français non disponible
2013-02-22
62A/864/INF

[Proposed Procedure for ensuring coherence of the general and collateral standards in support of having undated references within IEC SC 62D particular standards - For the April 2013 Subcommittee meeting in Shangai, China (Agenda item 9.1) ]

Titre français non disponible
2013-02-22
62A/865/INF

[Recommendations by the Ad Hoc Group on Symbols for consideration by ISO/TC 210 and IEC/SC 62A - For the April 2013 Subcommittee meeting in Shangai, China (Agenda item 7.1) ]

Titre français non disponible
2013-02-22
62A/866/INF

[Maintenance Cycle - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 6.3)]

Titre français non disponible
2013-02-22
62A/867/INF

[Chairman's Proposal to establish a formal liaison with IEC/TC 108 - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 8.3)]

Titre français non disponible
2013-02-22
62A/868/INF

[IEC/SC 62A Liaison reports - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 8.1)]

Titre français non disponible
2013-02-22
62A/869/INF

[Report of the Secretariat: Covering activities of the Secretariat since the Nuremburg meeting (2011-09-21) - Report as of 22 February 2013 - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 5.1) ]

Titre français non disponible
2013-02-22
62A/808A/CC

[Revised compilation of comments on 62A/798/CD - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment]

Titre français non disponible
2013-02-22yes
62A/860/INF

[Reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A - For the April 2013 Subcommittee meeting in Shanghai, China ]

Titre français non disponible
2013-02-15
62A/858/ISH

Feuille d'interprétation pour la publication CEI 60601-1:2005 et CEI 60601-1 (Troisième édition - 2005 et XXX - 2012), - Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
2013-02-012013-04-05?
TC 66
TC 76
62A/859/DTR

[ISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software]

Titre français non disponible
2013-02-012013-04-05no
TC 66
TC 76
62A/857A/RVC

[Revised result of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2013-02-01no
62A/855/CC

[Compilation of comments on 62A/839/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety]

Titre français non disponible
2013-01-25?
62A/856/NP

[ISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1]

Titre français non disponible
2013-01-252013-04-26?
62A/857/RVC

[Result of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2013-01-25no
62A/851/RVC

[Result of voting on 62A/822/CDV - Amendment 1 to IEC 60601-1-9: 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
2013-01-18yes
62A/852/RVC

[Result of voting on 62A/827/CDV - Amendment 1 to IEC 60601-1-10: 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
2013-01-18yes
62A/853/RVC

[Result of voting on 62A/826/CDV - Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices ]

Titre français non disponible
2013-01-18yes
62A/854/CC

[Compilation of ocmments on 62A/838/CD - IEC 62304: Medical device software - Software life cycle processes]

Titre français non disponible
2013-01-18yes
62A/819A/RVC

[Revised result of voting on 62A/796/CDV - IEC 60601-1-12: 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
2013-01-11yes
62A/849/DA

[Draft agenda for the meeting to be held in Shanghai, China on 2013-04-17 (starting time: 09:00) to (approximate finishing time: 12:00) ]

Titre français non disponible
2012-12-21
62A/845/INF

2012-12-07
62A/846/INF

[Results of document for comment 62A/834A/DC - Periodic review of documents under the jurisdiction of Subcommittee 62A: IEC 60601-1-4, Ed. 1.0 (1996-05-31) / IEC 60601-1-4-am1 Ed. 1.0 (1999-10-29), Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems ]

Titre français non disponible
2012-12-07
62A/847/RVN

[Result of voting on 62A/816/NP - IEC/TR 80001-2-5: Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance Guidance on distributed alarm systems]

Titre français non disponible
2012-12-07?
62A/848/INF

[Result of document for comments 62A/836/DC: Proposal for an Interpretation Sheet for IEC 60601-1: 2005+A1: 2012]

Titre français non disponible
2012-12-07
62A/844/CD

[IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible
2012-11-232013-03-01yesReport of Comments
TC 66
TC 76
62A/843/NP

[ISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x Guidance for responsibility agreements]

Titre français non disponible
2012-11-092013-02-15?Voting Result
62A/842/RVC

[Result of voting on 62A/814/CDV - Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability]

Titre français non disponible
2012-11-02yes
62A/838/CD

[IEC 62304: Medical device software - Software life cycle processes]

Titre français non disponible
2012-10-262013-01-11yesReport of Comments
TC 66
TC 76
62A/839/CD

[IEC 82304-1: Health Software - Part 1: General requirements for product safety]

Titre français non disponible
2012-10-262013-01-11?Report of Comments
TC 66
TC 76
62A/840/DTR

[ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2012-10-262013-01-11noVoting Result
TC 66
TC 76
62A/841/RVC

[Result of voting on 62A/831/DTR - IEC/TR 62348: Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of the IEC 60601-1:2005 to the previous edition]

Titre français non disponible
2012-10-26no
62A/751B/RVN

[Revised result of voting on 62A/732/NP: New Work Item proposal on Healthcare Software Systems - Part 1: General requirements]

Titre français non disponible
2012-10-26?
62A/837/RVD

Rapport de vote sur le 62A/824/FDIS - Amendement 1 à la CEI 60601-1-8 : 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
2012-10-19yes
62A/833A/CC

[Compilation of comments on 62A/809/CD - ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2012-10-19no
62A/835/RVC

[Result of voting on 62A/818/DTR - IEC/TR 80001-2-4: Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for Healthcare Delivery Organizations]

Titre français non disponible
2012-10-12?
62A/836/DC

[Proposal for an Interpretation Sheet for IEC 60601-: 2005+A1: 2012 ]

Titre français non disponible
2012-10-122012-11-23Report of Comments
62A/822/CDV

Amendement 1 à la CEI 60601-1-9: Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable
2012-09-282013-01-11yesVoting Result
TC 66
TC 76
62A/826/CDV

Amendement 1 à la CEI 62366 : Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
2012-09-282013-01-11yesVoting Result
TC 66
TC 76
62A/827/CDV

Amendement 1 à la CEI 60601-1-10: 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
2012-09-282013-01-11yesVoting Result
TC 66
TC 76
62A/834A/DC

[Revised periodic review of documents under the jurisdiction of Subcommittee 62A. (The title in table 1 has been corrected)]

Titre français non disponible
2012-09-282012-11-09Report of Comments
62A/833/CC

[Compilation of comments on 62A/809/CD - ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2012-09-14no
62A/834/DC

[Periodic review of documents under the jurisdiction of Subcommittee 62A]

Titre français non disponible
2012-09-14
62A/832/RVC

[Result of voting on 62A/801A/CDV - IEC 60601-1-2: 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
2012-08-31yes
62A/829/RQ

[Result of questionnaire 62A/815/Q: Proposal to repurpose IEC/TR 62348 to provide an Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005]

Titre français non disponible
2012-08-17
62A/830/RR

[Review report of IEC/TR 62348: Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended]

Titre français non disponible
2012-08-17no
62A/831/DTR

[IEC/TR 62348: Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of the IEC 60601-1:2005 to the previous edition]

Titre français non disponible
2012-08-172012-10-19noVoting Result
TC 66
TC 76
62A/828/INF

[Results of document for comments 62A/813/DC - ISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software]

Titre français non disponible
2012-08-03
62A/824/FDIS

Amendement 1 à la CEI 60601-1-8 : 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
2012-07-272012-09-28yesVoting Result
TC 66
TC 76
62A/825/RR

[Review report of IEC 62366: Medical devices - Application of usability engineering to medical devices]

Titre français non disponible
2012-07-27yes
62A/810A/INF

[Amended results of 62A/799/DC: Proposal to initiate a fast-track amendment to IEC 62366:2007, Medical devices - Application of usability engineering ]

Titre français non disponible
2012-07-27
62A/821/RR

[Review Report of IEC 60601-1-9: 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
2012-07-20yes
62A/823/RR

[Review report of IEC - 60601-1-10: 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
2012-07-20yes
62A/820/RVD

Rapport de vote sur le 62A/805/FDIS - Amendement 1 - CEI 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
2012-07-06yes
62A/819/RVC

[Result of voting on 62A/796/CDV - IEC 60601-1-12: 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
2012-06-22yes
62A/818/DTR

[IEC/TR 80001-2-4: Application of risk management forIT-networks incorporating medical devices - Part 2-4: General implementation guidance for Healthcare Delivery Organizations]

Titre français non disponible
2012-06-082012-08-10?Voting Result
TC 66
TC 76
62A/788A/RVN

[Amended results of voting on 62A/760/NP: Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for Healthcare Delivery Organizations]

Titre français non disponible
2012-06-08?
62A/817/INF

[Results of 62/246/Q: Questionnaire on the proposal of the Secretariats of IEC/TC 62 and its subcommittees to initiate early maintenance on several Collateral Standards in the IEC 60601 Series]

Titre français non disponible
2012-06-01
62A/811/INF

[Implementation of EN 62304, Medical device software - software lifecycle processes. Request for questions on CE-conformity matters]

Titre français non disponible
2012-05-25
62A/812/RVN

[ISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software]

Titre français non disponible
2012-05-25no
62A/813/DC

[Working Draft: ISO/TR 17791 Ed. 1.0: Health informatics - Guidance on standards for enabling safety in health software ]

Titre français non disponible
2012-05-252012-07-27Report of Comments
62A/814/CDV

Amendement 1 - CEI 60601-1-6: Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation
2012-05-252012-10-26yesVoting Result
TC 66
TC 76
62A/815/Q

[Proposal to repurpose IEC/TR 62348 to provide an Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 ]

Titre français non disponible
2012-05-252012-07-27Report of Comments
62A/816/NP

[Application of risk management for IT-networks incorporating medical devices - Part 2-x: Guidance on distributed alarm systems]

Titre français non disponible
2012-05-252012-09-07?Voting Result
62A/810/INF

[Results of 62A/799/DC: Proposal to initiate a fast-track amendment to IEC 62366:2007, Medical devices - Application of usability engineering ]

Titre français non disponible
2012-05-18
62A/808/CC

[Compilation of comments on 62A/798/CD - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment]

Titre français non disponible
2012-05-11yes
62A/809/CD

[ISO/TR 24971: Guidance on the application of ISO 14971]

Titre français non disponible
2012-05-112012-08-17noReport of Comments
TC 66
TC 76
62A/806/CC

[Compilation of comments on 62A/794/CD - Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirement for basic safety and essential performance -Collateral standard: Usability]

Titre français non disponible
2012-05-04yes
62A/807/RVC

[Result of voting on 62A/783/DTR - IEC/TR 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]

Titre français non disponible
2012-05-04no
62A/805/FDIS

Amendement 1 - CEI 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
2012-04-272012-06-29yesVoting Result
TC 66
TC 76
62A/803/RVC

[Result of voting on 62A/782/DTR - IEC/TR 80001-2-1 Ed1:Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples]

Titre français non disponible
2012-04-13no
62A/804/RVC

[Result of voting on 62A/804/DTR - IEC/TR 80001-2-3 Ed1: Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks]

Titre français non disponible
2012-04-13no