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 2015-12-04

Référence, Titre
Downloads

Date de

Circulation

Date de

Fermeture

CENELEC

Votes /

Commentaires

Comit?s

Authoris?s

62A/1162/DC

[Proposal to initiate an amendment to Medical devices – Application of usability engineering to medical devices]

Titre français non disponible

2016-11-25 2017-01-20 N/A
62A/1154/AC

[MT 23: Electromagnetic compatibility - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1155/AC

[MT 28: Electrical hazards - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1156/AC

[MT 29: Mechanical hazards - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1157/AC

[MT 30: Overheating, fire protection and additional hazards - Call for Experts and nominations for the Convener]

Titre français non disponible

2016-11-04 2016-12-16 N/A
62A/1158/AC

[JWG 2 with ISO/TC 121/SC 3: Joint working group on alarms - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1159/AC

[JWG 4 with ISO/TC 210: Joint working group on Medical devices - General requirements for safety and essential performance - Usability - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1160/AC

[JWG 5 with ISO/TC 121/SC 3: Joint working group on Physiologic Closed-Loop Controllers - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1161/AC

[JWG 6 with ISO/TC 121/SC 3: Joint working group on medical electrical equipment and systems for use in home care applications - Call for Experts]

Titre français non disponible

2016-11-04 N/A
62A/1136B/INF

[Revised IEC/SC 62A Liaison Reports for the October 2016 Subcommittee Meeting in Frankfurt, Germany (Agenda item 9.1)]

Titre français non disponible

2016-10-28 N/A
62A/1151/RVD

Rapport de vote sur le 62A/1140/FDIS - IEC 82304-1: Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits

2016-10-28 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1152/RR

[Review report of IEC TR 60601-4-3 Ed.1.0: Medical electrical equipment - Part 4-3: Guidance and interpretation Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements]

Titre français non disponible

2016-10-28 N
62A/1153/INF

[Result of the Call for Experts To work on a new project within IEC/SC 62A - ISO/TC 215 Joint Working Group (JWG) 7 to revise IEC 80001-1:2010 - 62A/1141/AC]

Titre français non disponible

2016-10-28 N/A
62A/1087A/INF

[Final Results of the National Committee Enquiry on 62A/1067/DC: Systematic Review of ISO 14971:2007, Medical devices - Application of risk management to medical devices ]

Titre français non disponible

2016-10-21 N/A
62A/1149/INF

[Results of voting on the Proposed 'Short List' of issues to be addressed in the next round of amendments to IEC 60601-1:2005 and the collateral standards under the jurisdiction of IEC/SC 62A]

Titre français non disponible

2016-10-21 N/A
62A/1150/RM

[Unconfirmed report of the meeting held in Frankfurt, Germany on 10 October 2016]

Titre français non disponible

2016-10-21 N/A
62A/1147/INF

[Result of the Enquiry on 62A/1120/DC: Proposal from IEC/SC 62A-ISO/TC 215 Joint Working Group 7 to update the Joint Working Group Title]

Titre français non disponible

2016-10-07 N/A
62A/1148/INF

[Results of the Enquiry on 62A/1113/DC: Preliminary concept from the Convener of IEC/SC 62A/MT 20 for a potential future new standard outside of the IEC 60601 series supporting environmental conscious design, maintenance and reuse of medical electrical equipment and systems and parts thereof including a substance related risk concept]

Titre français non disponible

2016-10-07 N/A
62A/1145/RQ

[Results of Questionnaire 62A/1123/Q: Proposal from the Japanese National Committee to add two issues to the 'short list' for IEC 60601-1 Ed. 3.1]

Titre français non disponible

2016-09-16 N/A
62A/1146/CC

[Compilation of comments on 62A/1101/CD - IEC 62304: Health software - Software life cycle processes ]

Titre français non disponible

2016-09-16 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1098A/DA

[Revised Draft agenda for the meeting to be held in Frankfurt, Germany on 2016-10-10 (starting time: 09:00 to approximate finishing time: 17:00) ]

Titre français non disponible

2016-09-09 N/A
62A/1132A/INF

[Revised report of the Secretariat - Covering activities of the Secretariat since the Kobe meeting (2015-11-10 and 2015-11-11) - Report as of 19 August 2016 (Agenda item 5.1) ]

Titre français non disponible

2016-09-09 N/A
62A/1134A/INF

[Revised Maintenance Cycle (Agenda Item 7.1) ]

Titre français non disponible

2016-09-09 N/A
62A/1135A/INF

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

Titre français non disponible

2016-09-09 N/A
62A/1136A/INF

[This document has been cancelled and replaced by 62A/1136B/INF.]

Titre français non disponible

2016-09-09 N/A
62A/1143/PW

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

Titre français non disponible

2016-09-09 N/A
62A/1144/RVN

[Result of voting on 62A/1096/NP: ISO 81001-1 Ed.1.0: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2016-09-09 U
62A/1140/FDIS

IEC 82304-1: Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits

2016-09-02 2016-10-14 Y Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1141/AC

[JWG 7 with ISO/TC 215 - Call for Experts]

Titre français non disponible

2016-09-02 N/A
62A/1142/INF

[Review of Active Participation of P-members in the Work of SC 62A]

Titre français non disponible

2016-09-02 N/A
62A/1138/RQ

[Result of Questionnaire 62A/1095/Q: Proposal to modify the title and scope of IEC 80001-1:2010 Application of risk management for it-networksincorporating medical devices - Part 1: Roles, responsibilities and activities ]

Titre français non disponible

2016-08-26 N/A
62A/1139/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

2016-08-26 Y
62A/1114A/INF

[Revised results of questionnaire 62A/1077/Q - IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance - Proposed 'Short List' of issues to be addressed in Amendment 2 - Items for ballot at the Frankfurt Meeting of IEC/SC 62A - Sorted by IEC 60601-1 Clause Number ]

Titre français non disponible

2016-08-19 N/A
62A/1131/INF

[Confirmation of working group conveners (Agenda Item 5.2) ]

Titre français non disponible

2016-08-19 N/A
62A/1132/INF

[This document has been cancelled and replaced by 62A/1132A/INF]

Titre français non disponible

2016-08-19 N/A
62A/1133/INF

[Reports form the Working Groups, Maintenance Teams and Joint Working Groups of IEC/SC 62A for the October 2016 Subcommittee meeting in Frankfurt, Germany (Agenda item 5.3)]

Titre français non disponible

2016-08-19 N/A
62A/1134/INF

[This document has been cancelled and replaced by 62A/1134A/NF]

Titre français non disponible

2016-08-19 N/A
62A/1135/INF

[This document has been cancelled and replaced by 62A/1135A/INF]

Titre français non disponible

2016-08-19 N/A
62A/1136/INF

[This document has been cancelled and replaced by 62A/1136A/INF]

Titre français non disponible

2016-08-19 N/A
62A/1137/INF

[Subcommittee 62A Liaison List (as of 2016-08-15) (Agenda item 9.2) ]

Titre français non disponible

2016-08-19 N/A
62A/1129/RVC

[Result of voting on 62A/1099/DTR - IEC TR 60601-4-1: Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy]

Titre français non disponible

2016-08-12 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1130/INF

[WHO Global Model Regulatory Framework for medical devices 6 including IVDS - Revised draft for comments - 21 July 2016 ]

Titre français non disponible

2016-08-12 N/A
62A/1125/RVC

[Result of voting on 62A/1093/DTR - ISO TR 80002-2, Medical device software - Part 2: Validation of software for medical device quality systems]

Titre français non disponible

2016-08-05 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1126/INF

[Communication from the German National Committee concerning certain items on the 'short lists' of issues to be consider in Frankfurt for inclusion in the 2019 amendments ]

Titre français non disponible

2016-08-05 N/A
62A/1127/CC

[Compilation of comments on 62A/1090/CD - IEC TR 60601-4-4: Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements]

Titre français non disponible

2016-08-05 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1128/RVC

[Result of voting on 62A/1097/DTR - IEC TR 80001-2-9 Ed.1: Application of risk management for IT networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities]

Titre français non disponible

2016-08-05 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1108A/INF

[Amended results of the National Committee Enquiry on 62A/1088/DC - Periodic review of documents under the jurisdiction of Subcommittee 62A]

Titre français non disponible

2016-07-29 N/A
62A/1113/DC

[Preliminary concept from the Convener of IEC/SC 62A/MT 20 for a potential future new standard outside of the IEC 60601 series supporting environmental conscious design, maintenance and reuse of medical electrical equipment and systems and parts thereof including a substance related risk concept ]

Titre français non disponible

2016-07-29 2016-09-30 N/A Report of Comments
62A/1114/INF

[This document has been cancelled and replaced by 62A/1114A/INF]

Titre français non disponible

2016-07-29 N/A
62A/1115/INF

[Results of questionnaire 62A/1078/Q - IEC 60601-1-2 Ed. 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - Proposed 'Short List' items of issues to be addressed in Amendment - 'Short List' Items for ballot at the Frankfurt Meeting of IEC/SC 62A - Sorted by IEC 60601-1-2 Clause Number ]

Titre français non disponible

2016-07-29 N/A
62A/1116/INF

[Results of questionnaire 62A/1079/Q - IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - Proposed 'Short List' of issues to be addressed in Amendment 2 - 'Short List' Items for ballot at the Frankfurt Meeting of IEC/SC 62A - Sorted by IEC 60601-1-6 Clause Number]

Titre français non disponible

2016-07-29 N/A
62A/1117/INF

[Results of questionnaire 62A/1080/Q - IEC 60601-1-8, Ed. 2.1, 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 system - Proposed 'Short List' of issues to be addressed in Amendment 2 - 'Short List' Items for ballot at the Frankfurt Meeting of IEC/SC 62A - Sorted by IEC 60601-1-8 Clause Number]

Titre français non disponible

2016-07-29 N/A
62A/1118/INF

[Results of questionnaire 62A/1082/Q - IEC 60601-1-10, Ed. 1.1, 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 - Proposed 'Short List' of issues to be addressed in Amendment 2 - 'Short List' Items for ballot at the Frankfurt Meeting of IEC/SC 62A - Sorted by IEC 60601-1-10 Clause Number]

Titre français non disponible

2016-07-29 N/A
62A/1119/INF

[Results of questionnaire 62A/1083/Q - 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 - Proposed 'Short List' of issues to be addressed in Amendment 1 - 'Short List' Items for ballot at the Frankfurt Meeting of IEC/SC 62A - Sorted by IEC 60601-1-11 Clause Number]

Titre français non disponible

2016-07-29 N/A
62A/1120/DC

[Proposal from IEC/SC 62A-ISO/TC 215 Joint Working Group 7 to update the Joint Working Group Title - Background and Rationale ]

Titre français non disponible

2016-07-29 2016-09-09 N/A Report of Comments
62A/1121/RQ

[Results of questionnaire 62A/1094/Q - Proposed withdrawal of IEC 62366 Ed. 1.1, Medical devices - Application of usability engineering to medical devices]

Titre français non disponible

2016-07-29 N/A
62A/1122/RR

[Review report on IEC TR 80002-3 Ed.1: Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)]

Titre français non disponible

2016-07-29 N/A
62A/1123/Q

[Questionnaire: Proposal from the Japanese National Committee to add two issues to the 'short list' for IEC 60601-1 Ed. 3.1]

Titre français non disponible

2016-07-29 2016-09-09 N/A Report of Comments
62A/1124/INF

[Invitation to participate in the work of ISO/TC 173/WG 11, Assistive products for tissue integrity when lying down ]

Titre français non disponible

2016-07-29 N/A
62A/1109/RR

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

Titre français non disponible

2016-06-24 N/A
62A/1110/RR

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

Titre français non disponible

2016-06-24 N/A
62A/1111/RR

[Review report on IEC TR 62296: Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements]

Titre français non disponible

2016-06-24 N/A
62A/1112/RR

[Review report on 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

2016-06-24 N/A
62A/1102/RQ

[Results of questionnaire 62A/1077/Q: IEC 60601-1 Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance - Proposed 'Short List' of issues to be addressed in Amendment 2]

Titre français non disponible

2016-06-17 N/A
62A/1103/RQ

[Results of questionnaire 62A/1078/Q: IEC 60601-1-2 Ed. 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests Proposed 'Short List' of issues to be addressed in Amendment 1 ]

Titre français non disponible

2016-06-17 N/A
62A/1104/RQ

[Results of questionnaire 62A/1079/Q: IEC 60601-1-6 Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability Proposed 'Short List' of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-06-17 N/A
62A/1105/RQ

[Results of questionnaire 62A/1080/Q: IEC 60601-1-8, Ed. 2.1, 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 system Proposed 'Short List' of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-06-17 N/A
62A/1106/RQ

[Results of questionnaire 62A/1082/Q: IEC 60601-1-10, Ed. 1.1, 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 - Proposed 'Short List' of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-06-17 N/A
62A/1107/RQ

[Results of questionnaire 62A/1083/Q: 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 -Proposed 'Short List' of issues to be addressed in Amendment 1 ]

Titre français non disponible

2016-06-17 N/A
62A/1108/INF

[Results of the National Committee Enquiry on 62A/1088/DC -Periodic review of documents under the jurisdiction of Subcommittee 62A]

Titre français non disponible

2016-06-17 N/A
62A/1099/DTR

[IEC TR 60601-4-1: Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy]

Titre français non disponible

2016-06-10 2016-08-05 N Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1100/RR

[Review report of IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2016-06-10 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1101/CD

[IEC 62304 Ed. 2: Health software - Software life cycle processes]

Titre français non disponible

2016-06-10 2016-09-02 Y Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1063A/CC

[Revised compilation of comments on 62A/1039/CD - IEC TR 80001-2-9: Application of risk management for IT networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities]

Titre français non disponible

2016-06-03 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1070A/CC

[Revised compilation of comments on 62A/1065/CD - IEC TR 60601-4-1: Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy ]

Titre français non disponible

2016-06-03 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1097/DTR

[IEC TR 80001-2-9 Ed.1: Application of risk management for IT networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities]

Titre français non disponible

2016-06-03 2016-07-29 N Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1098/DA

[Draft agenda for the meeting to be held in Frankfurt, Germany on 2016-10-10 (starting time: 09:00 to approximate finishing time: 17:00) ]

Titre français non disponible

2016-06-03 N/A
62A/1042C/CC

[Revised compilation of comments on 62A/1016/CD - ISO TR 80002-2: Medical device software - Part 2: Validation of software for regulated processes ]

Titre français non disponible

2016-05-27 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1066A/RVC

[Revised result of voting on 62A/1013/CDV - IEC 82304-1: Health Software - Part 1: General requirements for product safety]

Titre français non disponible

2016-05-27 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1093/DTR

[ISO TR 80002-2, Medical device software - Part 2: Validation of software for medical device quality systems]

Titre français non disponible

2016-05-27 2016-07-22 N Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1094/Q

[Proposed withdrawal of IEC 62366 Ed. 1.1, Medical devices - Application of usability engineering to medical devices ]

Titre français non disponible

2016-05-27 2016-07-08 N/A Report of Comments
62A/1095/Q

[Proposal to modify the title and scope of IEC 80001-1:2010 - Application of risk management for it-networks incorporating medical devices - Part 1: Roles, responsibilities and activities ]

Titre français non disponible

2016-05-27 2016-08-19 N/A Report of Comments
62A/1096/NP

[Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms]

Titre français non disponible

2016-05-27 2016-08-19 U Voting Result
62A/1091/INF

[Communication from the Secretary of ISO/TC 210 regarding ISO 14971, Medical devices - Application of risk management to medical devices. Removal from the list of ISO standards designated as management system standards ]

Titre français non disponible

2016-05-20 N/A
62A/1092/INF

[Report of IEC/SC 62A-ISO/TC 215 Joint Working Group 7 May 2016 ]

Titre français non disponible

2016-05-20 N/A
62A/1008A/RQ

[Revised result of Questionnaire 62A/1005/Q: Proposal to publish guidance for writers of particular standards on creating alarm system related requirements as a technical report]

Titre français non disponible

2016-05-06 N/A
62A/1090/CD

[IEC/TR 60601-4-4: Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements]

Titre français non disponible

2016-05-06 2016-07-29 N Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1088/DC

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

Titre français non disponible

2016-04-29 2016-06-10 N/A Report of Comments
62A/1089/INF

[Appointment of the ISO Co-convener of ISO/TC 210 - IEC/SC 62A Joint Working Group (JWG) 1: Application of risk management to medical devices ]

Titre français non disponible

2016-04-29 N/A
62A/1087/INF

[Results of the National Committee Enquiry on 62A/1067/DC: Systematic Review of ISO 14971:2007, Medical devices - Application of risk management to medical devices ]

Titre français non disponible

2016-04-01 N/A
62A/1085/INF

[Final report of comments on 62A/1010/DC: Draft revision of ISO/IEC DGuide 63: Guide to the development and inclusion of aspects of safety in International Standards for medical devices.]

Titre français non disponible

2016-03-25 N/A
62A/1086/INF

[Future of the ISO/IEC 80003 Series: Physiological quantities and their units - Committee Internal Ballot being conducted by ISO/TC 215, Health informatics]

Titre français non disponible

2016-03-25 N/A
62A/1075/INF

[Report of comments and comments on 62A/1072/DC: Convenership of IEC/SC 62A/WG 20, Environmental protection]

Titre français non disponible

2016-03-11 N/A
62A/1076/INF

[Unconfirmed report of the thirty-second meeting of IEC/SC 62A/AG 33 held on 22-24 February 2016 ]

Titre français non disponible

2016-03-11 N/A
62A/1077/Q

[Questionnaire on IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance - Proposed "Short" List of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-03-11 2016-06-03 N/A Report of Comments
62A/1078/Q

[Questionnaire on IEC 60601-1-2 Ed. 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - Proposed "Short" List of issues to be addressed in Amendment 1 ]

Titre français non disponible

2016-03-11 2016-06-03 N/A Report of Comments
62A/1079/Q

[IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - Proposed "Short" List of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-03-11 2016-06-03 N/A Report of Comments
62A/1080/Q

[Questionnaire on IEC 60601-1-8, Ed. 2.1, 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 system - Proposed "Short" List of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-03-11 2016-06-03 N/A Report of Comments
62A/1081/INF

[Report of the deliberations of the IEC/SC 62A Chairman Advisory Group on IEC 60601-1-9, Ed. 1.1, 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

2016-03-11 N/A
62A/1082/Q

[Questionnaire on IEC 60601-1-10, Ed. 1.1, 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 - Proposed "Short" List of issues to be addressed in Amendment 2 ]

Titre français non disponible

2016-03-11 2016-06-03 N/A Report of Comments
62A/1083/Q

[Questionnaire on 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 - Proposed "Short" List of issues to be addressed in Amendment 1 ]

Titre français non disponible

2016-03-11 2016-06-03 N/A Report of Comments
62A/1084/INF

[Report of the deliberations of the IEC/SC 62A Chairman Advisory Group on IEC 60601-1-12, Ed. 1.0, 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

2016-03-11 N/A
62A/1073A/RVC

[Revised result of voting on 62A/1068/DTR - 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

2016-03-04 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
SC 77A
SC 77B
TC 108
62A/1074/INF

[Sudden Death of IEC/SC 62D Secretary - Mr. Michael W. Schmidt]

Titre français non disponible

2016-03-04 N/A
62A/1040A/RVC

[Revised result of voting on 62A/1015/DTR - IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices]

Titre français non disponible

2016-02-19 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1043A/RVC

[Revised result of voting on 62A/1018/DTR - 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

2016-02-19 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1073/RVC

[Result of voting on 62A/1068/DTR - 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

2016-01-29 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
SC 77A
SC 77B
TC 108
62A/1070/CC

[Compilation of comments on 62A/1065/CD - IEC TR 60601-4-1: Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy ]

Titre français non disponible

2016-01-22 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1071/INF

[Report of IEC/SC 62A-ISO/TC 215 Joint Working Group 7 - November 2015]

Titre français non disponible

2016-01-22 N/A
62A/1072/DC

[Convenership of IEC/SC 62A/WG 20, Environmental protection]

Titre français non disponible

2016-01-22 2016-03-04 N/A Report of Comments
62A/1042B/CC

[Revised compilation of comments on 62A/1016/CD - ISO TR 80002-2: Medical device software - Part 2: Validation of software for regulated processes ]

Titre français non disponible

2016-01-15 N
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108