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 2013-12-29

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62A/948A/RVC

[Revised result of voting on 62A/925/CDV - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes]

Titre français non disponible
2014-12-19yes
62A/979/DC

[Health Software Ad hoc Group Draft Report - September 2014 Health Software and Health IT Safety Standards - FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report ]

Titre français non disponible
2014-12-192015-02-20
62A/980/RM

[Unconfirmed minutes of the meeting held in New Orleans, Louisiana, USA on 24 November 2014]

Titre français non disponible
2014-12-19
62A/981/INF

[Maintenance Cycle - As approved by IEC/SC 62A in New Orleans (see 62A/980/RM) ]

Titre français non disponible
2014-12-19
62A/978/RVD

Rapport de vote sur le 62A/959/FDIS - IEC 60601-1-11: 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
2014-12-12yes
62A/977/FDIS

IEC 62366-1: Dispositifs médicaux: Partie 1: Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
2014-11-282015-01-30yes
TC 66
TC 76
62A/968B/INF

[Revised IEC/SC 62A Liaison reports (Agenda item 9.1)]

Titre français non disponible
2014-11-14
62A/976/INF

[Results of document for comment 62A/962/DC - Periodic review of documents under the jurisdiction of Subcommittee 62A ]

Titre français non disponible
2014-11-14
62A/960A/INF

[Revised result of the Call for Experts for IEC/SC 62A-ISO/TC 215 JWG 7: Project IEC 62304 Ed. 2.0]

Titre français non disponible
2014-11-07
62A/974/DC

[Request for comments from ISO/TC 215 on a New Work Item Proposal for a Technical Specification on "Framework of Event Data & Reporting Definitions for the Safety of Health Software" ]

Titre français non disponible
2014-11-072015-02-06
62A/975/NP

[Application of risk management for IT networks incorporating medical devices - Part 2-x: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities]

Titre français non disponible
2014-11-072015-02-13?
62A/973/RVC

[Result of voting on 62A/951/DTR - IEC TR 60601-4-3: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unclear or unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements]

Titre français non disponible
2014-10-31no
62A/949A/DA

[Revised draft agenda for the meeting to be held in New Orleans, Louisiana, USA on 2014-11-24 (starting time: 09:00) to (approximate finishing time: 12:00) ]

Titre français non disponible
2014-10-24
62A/967A/INF

[Updated reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A (Agenda item 5.2) ]

Titre français non disponible
2014-10-24
62A/968A/INF

[Updated IEC/SC 62A Liaison reports (Agenda item 9.1)]

Titre français non disponible
2014-10-24
62A/969/INF

[Secretariat's view of the programme of work of the subcommittee (Agenda item 8.1)]

Titre français non disponible
2014-10-24
62A/970/PW

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

Titre français non disponible
2014-10-24
62A/971/CD

[IEC TR 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems]

Titre français non disponible
2014-10-242015-01-09?
TC 66
TC 76
TC 108
62A/972/DTR

IEC TR 60878: Symboles graphiques des équipements électriques en pratique médicale
2014-10-242015-01-09no
TC 66
TC 76
TC 108
62A/939A/CC

[Revised compilation of comments on 62A/926/CD - IEC TR 60878: Graphical symbols for electrical equipment in medical practice]

Titre français non disponible
2014-10-17no
62A/966/INF

[Report of the Secretariat (Agenda item 5.1)]

Titre français non disponible
2014-10-10
62A/967/INF

[Reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A (Agenda item 5.2) ]

Titre français non disponible
2014-10-10
62A/968/INF

[IEC/SC 62A Liaison reports (Agenda item 9.1)]

Titre français non disponible
2014-10-10
62A/963/INF

[Confirmation of working group conveners (Agenda Item 5.1.1) ]

Titre français non disponible
2014-10-03
62A/964/INF

[Subcommittee 62A Liaison List ]

Titre français non disponible
2014-10-03
62A/965/INF

[Maintenance Cycle (Agenda item 7.1)]

Titre français non disponible
2014-10-03
62A/959/FDIS

IEC 60601-1-11: 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
2014-09-262014-11-28yesVoting Result
TC 66
TC 76
62A/960/INF

[Result of the Call for Experts for IEC/SC 62A-ISO/TC 215 JWG 7: Project IEC 62304 Ed. 2.0]

Titre français non disponible
2014-09-26
62A/961/INF

[Health Software Ad hoc group Draft Report - September 2014 Health Software and Health IT Safety Standards FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report ]

Titre français non disponible
2014-09-26
62A/962/DC

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

Titre français non disponible
2014-09-262014-11-07Report of Comments
62A/955/RVC

[Result of voting on 62A/943/DTR - 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
2014-09-19no
62A/956/RVC

[Result of voting on 62A/945/DTR - ISO TR 80001-2-7: Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1]

Titre français non disponible
2014-09-19no
62A/957/INF

[Report of comments and comments on 62A/950/DC: Appointment of an IEC Co-convener for IEC/SC 62A-ISO/TC 210 JWG 4, Medical devices - General requirements for safety and essential performance - Usability ]

Titre français non disponible
2014-09-19
62A/958/DC

[ISO/DIS 27799: Health informatics - Information security management in health using ISO/IEC 27002 ]

Titre français non disponible
2014-09-192015-02-06
62A/954/RQ

[Result of questionnaire 62A/944/Q: Proposal to modify the scope of IEC/SC 62A ISO/TC 215 Joint Working Group (JWG) 7, Application of risk management to information technology (IT) networks incorporating medical devices]

Titre français non disponible
2014-09-05
62A/953/RVD

Rapport de vote sur le 62A/942/FDIS - IEC 62353: Appareils électromédicaux - Essai récurrent et essai après réparation d'un appareil électromédical
2014-08-22yes
62A/951/DTR

[IEC TR 60601-4-3: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unclear or unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements]

Titre français non disponible
2014-08-152014-10-17noVoting Result
TC 66
TC 76
TC 108
62A/952/CC

[Compilation of comments on 62A/940/CD - IEC TR 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 80001-2-2]

Titre français non disponible
2014-08-15?
62A/950/DC

[Co-convenership of IEC/SC 62A-ISO/TC 210 JWG 4, Medical devices - General requirements for safety and essential performance - Usability ]

Titre français non disponible
2014-08-012014-09-12Report of Comments
62A/948/RVC

[Result of voting on 62A/925/CDV - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes]

Titre français non disponible
2014-07-25yes
62A/949/DA

[Draft agenda for the meeting to be held in New Orleans, Louisiana, USA on 2014-11-24 (starting time: 09:00) to (approximate finishing time: 12:00) ]

Titre français non disponible
2014-07-25
62A/947/RVC

[Result of voting on 62A/936/DTR - IEC TR 62354: General testing procedures for medical electrical equipment]

Titre français non disponible
2014-07-11no
62A/933A/RVC

[Revised result of voting on 62A/900A/CDV - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible
2014-07-04yes
62A/945/DTR

[ISO TR 80001-2-7: Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1]

Titre français non disponible
2014-07-042014-09-05noVoting Result
TC 66
TC 76
TC 108
62A/946/AC

[IEC/SC 62A-ISO/TC 215 JWG 7: IEC 62304 Ed. 2.0 - Call for experts]

Titre français non disponible
2014-07-04
62A/934A/CC

[Revised compilation of comments on 62A/923/CD - ISO TR 80001-2-7: Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1]

Titre français non disponible
2014-06-27no
62A/935A/CC

[Revised compilation of comments on 62A/919/CD - IEC TR 60601-4-3: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unclear or unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements]

Titre français non disponible
2014-06-27no
62A/944/Q

[Proposal to modify the scope of IEC/SC 62A - ISO/TC 215 Joint Working Group (JWG) 7, Application of risk management to information technology (IT) networks incorporating medical devices ]

Titre français non disponible
2014-06-272014-08-15Report of Comments
62A/941A/RVC

[Result of voting on 62A/922A/CDV - IEC 60601-1-11: 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
2014-06-20yes
62A/943/DTR

[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
2014-06-202014-09-05noVoting Result
TC 66
TC 108
62A/942/FDIS

[IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment ]

Titre français non disponible
2014-06-132014-08-15yesVoting Result
TC 66
TC 76
62A/929A/RVN

[Revised result of voting on 62A/915/NP: Application of risk management for IT-networks incorporating medical devices Part 2-x: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2]

Titre français non disponible
2014-06-06?
62A/938/RVD

Rapport de vote sur le 62A/932/FDIS - IEC 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
2014-06-06yes
62A/939/CC

[Compilation of comments on 62A/926/CD - IEC TR 60878: Graphical symbols for electrical equipment in medical practice]

Titre français non disponible
2014-06-06no
62A/940/CD

[IEC TR 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 80001-2-2]

Titre français non disponible
2014-06-062014-08-08?Report of Comments
TC 66
TC 76
TC 108
62A/941/RVC

[Result of voting on 62A/922A/CDV - IEC 60601-1-11: 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
2014-06-06yes
62A/931A/CC

[Revised compilation of comments on 62A/917/CD - 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
2014-05-30no
62A/925F/CDV

Amendement 1 à l'IEC 62304: Logiciels d'appareils médicaux - Processus du cycle de vie du logiciel
2014-05-16yes
TC 66
TC 76
TC 108
62A/937/INF

[Health Software Ad hoc group Interim Report - May 2014 Health Software Safety Standards / Future State Architecture/Framework - Discussion draft ]

Titre français non disponible
2014-05-16
TC 66
TC 76
62A/936/DTR

[IEC TR 62354: General testing procedures for medical electrical equipment]

Titre français non disponible
2014-05-022014-07-04noVoting Result
TC 66
TC 76
62A/925/CDV

Amendement 1 à l'IEC 62304: Logiciels d'appareils médicaux - Processus du cycle de vie du logiciel
2014-04-182014-07-18yesVoting Result
TC 66
TC 76
TC 108
62A/935/CC

[Compilation of comments on 62A/919/CD - IEC TR 60601-4-3: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unclear or unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements]

Titre français non disponible
2014-04-04no
62A/930A/CC

[Revised compilation of comments on 62A/913/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety]

Titre français non disponible
2014-03-28?
62A/932/FDIS

IEC 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
2014-03-282014-05-30yesVoting Result
TC 66
TC 76
62A/933/RVC

[Result of voting on 62A/900A/CDV - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible
2014-03-28yes
62A/934/CC

[Compilation of comments on 62A/923/CD - ISO TR 80001-2-7: Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1]

Titre français non disponible
2014-03-28no
62A/931/CC

[Compilation of comments on 62A/917/CD - 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
2014-03-21no
62A/929/RVN

[Result of voting on 62A/915/NP: Application of risk management for IT-networks incorporating medical devices Part 2-x: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2]

Titre français non disponible
2014-03-14?
62A/930/CC

[Compilation of comments on 62A/913/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety]

Titre français non disponible
2014-03-14?
62A/922A/CDV

[IEC 60601-1-11: 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
2014-03-072014-05-30yesVoting Result
TC 66
TC 76
62A/928/RVC

[Result of voting on 62A/918/DTR - IEC/TR 80002-3: Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)]

Titre français non disponible
2014-03-07no
62A/922/CDV

[Withdrawn]

Titre français non disponible
2014-02-28yes
TC 66
TC 76
62A/927/RVC

[Result of voting on 62A/859/DTR - ISO/DTR 17791: Guidance on Standards for Enabling Safety in Health Software]

Titre français non disponible
2014-02-28no
62A/910A/CC

[Revised compilation of comments on 62A/886/CD - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes]

Titre français non disponible
2014-02-21yes
62A/926/CD

[IEC/TR 60878: Graphical symbols for electrical equipment in medical practice]

Titre français non disponible
2014-02-212014-05-23noReport of Comments
TC 66
TC 76
62A/924/RVD

Rapport de vote sur le 62A/916/FDIS: IEC 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
2014-02-07yes
62A/894A/RVC

[Revised result of voting on 62A/863/CDV - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment]

Titre français non disponible
2014-01-24yes
62A/923/CD

[Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1]

Titre français non disponible
2014-01-172014-03-21noReport of Comments
TC 66
TC 76
62A/900A/CDV

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

Titre français non disponible
2014-01-102014-03-21yesVoting Result
TC 66
TC 76