International Standards and Conformity Assessment
for all electrical, electronic and related technologies
SC 62A |
Aspects généraux des équipements électriques utilisés en pratique médicale |

Référence, Titre | Downloads | Date de Circulation | Date de Fermeture | CENELEC | Votes / Commentaires | Comit?s Authoris?s |
|---|---|---|---|---|---|---|
62A/859/DTR
[ISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software]
Titre français non disponible
| 2013-02-01 | 2013-04-05 | ? | 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
| 2013-02-01 | no | ||||
62A/858/ISHFeuille 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 | 2013-02-01 | 2013-04-05 | ? | TC 66 TC 76 | ||
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/857/RVC
[Result of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971]
Titre français non disponible
| 2013-01-25 | no | ||||
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
| 2013-01-25 | 2013-04-26 | ? | |||
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
| 2013-01-18 | yes | ||||
62A/854/CC
[Compilation of ocmments on 62A/838/CD - IEC 62304: Medical device software - Software life cycle processes]
Titre français non disponible
| 2013-01-18 | yes | ||||
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
| 2013-01-18 | yes | ||||
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
| 2013-01-18 | yes | ||||
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
| 2013-01-11 | yes | ||||
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/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/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/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/845/INF
| 2012-12-07 | |||||
62A/844/CD
[IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices]
Titre français non disponible
| 2012-11-23 | 2013-03-01 | yes | 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
| 2012-11-09 | 2013-02-15 | ? | |||
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
| 2012-11-02 | yes | ||||
62A/838/CD
[IEC 62304: Medical device software - Software life cycle processes]
Titre français non disponible
| 2012-10-26 | 2013-01-11 | yes | Report of Comments | 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
| 2012-10-26 | no | ||||
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/840/DTR
[ISO/TR 24971: Guidance on the application of ISO 14971]
Titre français non disponible
| 2012-10-26 | 2013-01-11 | no | Voting Result | TC 66 TC 76 | |
62A/839/CD
[IEC 82304-1: Health Software - Part 1: General requirements for product safety]
Titre français non disponible
| 2012-10-26 | 2013-01-11 | ? | Report of Comments | TC 66 TC 76 | |
62A/837/RVDRapport 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
| 2012-10-19 | yes | ||||
62A/833A/CC
[Compilation of comments on 62A/809/CD - ISO/TR 24971: Guidance on the application of ISO 14971]
Titre français non disponible
| 2012-10-19 | no | ||||
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
| 2012-10-12 | 2012-11-23 | Report of Comments | |||
62A/822/CDVAmendement 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 | 2012-09-28 | 2013-01-11 | yes | Voting 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
| 2012-09-28 | 2012-11-09 | Report of Comments | |||
62A/827/CDVAmendement 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 | 2012-09-28 | 2013-01-11 | yes | Voting Result | TC 66 TC 76 | |
62A/826/CDVAmendement 1 à la CEI 62366 : Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux | 2012-09-28 | 2013-01-11 | yes | Voting Result | TC 66 TC 76 | |
62A/833/CC
[Compilation of comments on 62A/809/CD - ISO/TR 24971: Guidance on the application of ISO 14971]
Titre français non disponible
| 2012-09-14 | no | ||||
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
| 2012-08-31 | yes | ||||
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/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
| 2012-08-17 | 2012-10-19 | no | Voting Result | TC 66 TC 76 | |
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
| 2012-08-17 | no | ||||
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/FDISAmendement 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
| 2012-07-27 | 2012-09-28 | yes | Voting Result | TC 66 TC 76 | |
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/825/RR
[Review report of IEC 62366: Medical devices - Application of usability engineering to medical devices]
Titre français non disponible
| 2012-07-27 | yes | ||||
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
| 2012-07-20 | yes | ||||
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
| 2012-07-20 | yes | ||||
62A/820/RVDRapport 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
| 2012-07-06 | yes | ||||
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
| 2012-06-22 | yes | ||||
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
| 2012-06-08 | 2012-08-10 | ? | 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/816/NP
[Application of risk management for IT-networks incorporating medical devices - Part 2-x: Guidance on distributed alarm systems]
Titre français non disponible
| 2012-05-25 | 2012-09-07 | ? | Voting Result | ||
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
| 2012-05-25 | 2012-07-27 | Report of Comments | |||
62A/814/CDVAmendement 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 | 2012-05-25 | 2012-10-26 | yes | Voting Result | TC 66 TC 76 | |
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
| 2012-05-25 | 2012-07-27 | Report of Comments | |||
62A/812/RVN
[ISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software]
Titre français non disponible
| 2012-05-25 | ? | ||||
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
[IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment]
Titre français non disponible
| 2012-05-11 | yes | ||||
62A/809/CD
[ISO/TR 24971: Guidance on the application of ISO 14971]
Titre français non disponible
| 2012-05-11 | 2012-08-17 | no | Report 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
| 2012-05-04 | yes | ||||
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
| 2012-05-04 | no | ||||
62A/805/FDISAmendement 1 - CEI 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
| 2012-04-27 | 2012-06-29 | yes | Voting 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
| 2012-04-13 | no | ||||
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
| 2012-04-13 | no | ||||
62A/802/AC
[Appointment of a new assistant secretary for SC62A]
Titre français non disponible
| 2012-03-30 | |||||
62A/751A/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
| 2012-03-30 | ? | ||||
62A/801A/CDVCEI 60601-1-2: Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Pertubation électromagnétique - Exigences et essais | 2012-03-23 | 2012-08-17 | yes | Voting Result | TC 66 TC 76 | |
62A/801/CDV
[Withdrawn and replaced by 62A/801A/CDV]
Titre français non disponible
| 2012-03-16 | 2012-08-17 | yes | TC 66 TC 76 | ||
62A/791A/RVC
[Result of voting on 62A/761/CDV: IEC 60601-1-8 A1 Ed.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 - Amendment 1 ]
Titre français non disponible
| 2012-03-16 | yes | ||||
62A/800/INF
[Report of voting on document SMB/4680/QP, New scope of TC 62, Electrical equipment in medical practice]
Titre français non disponible
| 2012-03-02 | |||||
62A/799/DC
[Proposal to initiate a fast-track amendment to IEC 62366:2007: Medical devices - Application of usability engineering to medical devices]
Titre français non disponible
| 2012-02-24 | 2012-04-27 | Report of Comments |



