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 2013-08-23

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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
2014-08-152014-10-17no
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
2014-08-012014-09-12
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
2014-07-042014-09-05no
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
2014-06-202014-09-05no
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
62A/900/CDV

[Withdrawn]

Titre français non disponible
2013-12-20yes
TC 66
TC 76
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
2013-12-202014-03-21noReport of Comments
TC 66
TC 76
62A/920/RQ

[Report of questionnaire 62A/902/Q: Proposal to advance the Working Draft of IEC 60601-1-11 Ed. 2.0: 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 to the Enquiry (CDV) Stage]

Titre français non disponible
2013-12-20
62A/921/RR

[Review report of IEC 60601-1-11 Ed.1.0: 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
2013-12-20yes
62A/847A/RVN

[Revised 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
2013-12-13no
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
2013-12-132014-03-14noReport of Comments
TC 66
TC 76
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
2013-12-132014-02-14noVoting Result
TC 66
TC 76
62A/897A/RVD

Rapport de vote sur le 62A/889/FDIS - Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices
2013-12-06yes
62A/901A/RVN

[Revised result of voting on 62A/901/NP: Medical electrical equipment - Part 4-x: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy]

Titre français non disponible
2013-11-29?
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
2013-11-292014-01-31yesVoting Result
TC 66
TC 76
62A/855A/CC

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

Titre français non disponible
2013-11-22?
62A/913/CD

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

Titre français non disponible
2013-11-222014-02-28?Report of Comments
TC 66
TC 76
62A/914/INF

[Supplemental Informative Document to Accompany ISO-IEC New Work Proposal to Develop IEC 80001-2-X, Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2 (62A/915/NP)]

Titre français non disponible
2013-11-22
62A/915/NP

[IEC 80001-2-x, 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
2013-11-222014-02-28?Voting Result
62A/896A/RVD

Rapport de vote révisé sur le 62A/888/FDIS - Amendement 1 à l'IEC 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
2013-11-15yes
62A/912/RVC

[Result of voting on 62A/981/DTR - ISO/TR 80001-2-6: Application of risk management for IT-networks incorporating medical device - Part 2-6: Application guidance - Guidance for responsibility agreements]

Titre français non disponible
2013-11-15no
62A/910/CC

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

Titre français non disponible
2013-11-01yes
62A/911/RR

[Review report of IEC/TR 62354 Ed.1.0: General testing procedures for medical electrical equipment]

Titre français non disponible
2013-11-01no
62A/903/INF

[Result of document for comment 62A/893/DC: Periodic review of documents under the jurisdiction of Subcommittee 62A ]

Titre français non disponible
2013-10-25
62A/904/RR

[Review report of IEC/TR 60513 Ed.2.0: Fundamental aspects of safety standards for medical electrical equipment]

Titre français non disponible
2013-10-25
62A/905/RR

[Review report of IEC/TR 60878 Ed.2.0: Graphical symbols for electrical equipment in medical practice]

Titre français non disponible
2013-10-25no
62A/906/RR

[Review report of IEC/TR 60930 Ed.2.0: Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems]

Titre français non disponible
2013-10-25
62A/907/RR

[Review report of IEC/TR 61258: Guidelines for the development and use of medical electrical equipment educational materials]

Titre français non disponible
2013-10-25
62A/908/RR

[Review report of IEC 80001-1 Ed.1.0: Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities]

Titre français non disponible
2013-10-25
62A/909/RR

[Review report of IEC/TR 80002-1 Ed.1.0: Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software]

Titre français non disponible
2013-10-25
62A/902/Q

[Proposal to advance the Working Draft of IEC 60601-1-11 Ed. 2.0 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 to the Enquiry (CDV) Stage]

Titre français non disponible
2013-10-182013-11-29Report of Comments
62A/887A/RVC

[Revised result of voting on 62A/850/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
2013-10-11yes
62A/899/CC

[Compilation of comments on 62A/884A/CD - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices]

Titre français non disponible
2013-10-11yes
62A/901/RVN

[Result of voting on 62A/901/NP: Medical electrical equipment - Part 4-x: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy]

Titre français non disponible
2013-10-11?
62A/896/RVD

Rapport de vote sur le 62A/888/FDIS - Amendement 1 à l'IEC 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
2013-09-20yes
62A/897/RVD

Rapport de vote sur le 62A/889
2013-09-20yes
62A/898/RVD

Rapport de vote sur le 62A/890
2013-09-20yes