International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62A

Common aspects of electrical equipment used in medical practice

 
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SC 62A Working Documents since 2015-04-30

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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
2016-04-01
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.
2016-03-25
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
2016-03-25
62A/1075/INF

Report of comments and comments on 62A/1072/DC: Convenership of IEC/SC 62A/WG 20, Environmental protection
2016-03-11
62A/1076/INF

Unconfirmed report of the thirty-second meeting of IEC/SC 62A/AG 33 held on 22-24 February 2016
2016-03-11
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
2016-03-112016-06-03
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
2016-03-112016-06-03
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
2016-03-112016-06-03
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
2016-03-112016-06-03
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
2016-03-11
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
2016-03-112016-06-03
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
2016-03-112016-06-03
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
2016-03-11
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
2016-03-04no
62A/1074/INF

Sudden Death of IEC/SC 62D Secretary - Mr. Michael W. Schmidt
2016-03-04
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
2016-02-19no
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
2016-02-19no
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
2016-01-29no
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
2016-01-22?
62A/1071/INF

Report of IEC/SC 62A-ISO/TC 215 Joint Working Group 7 - November 2015
2016-01-22
62A/1072/DC

Convenership of IEC/SC 62A/WG 20, Environmental protection
2016-01-222016-03-04Report 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
2016-01-15no
62A/1069/RM

Unconfirmed report of the meeting held in Kobe, Japan on 10-11 November 2015
2015-11-27
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
2015-11-202016-01-22noVoting Result
TC 65
TC 66
TC 76
TC 77
TC 108
62A/1045A/INF

Revised IEC/SC 62A liaison reports for the November 2015 Subcommittee meeting in Kobe, Japan (Agenda item 8.1)
2015-11-13
62A/1053A/CC

Revised compilation of comments on 62A/1029/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
2015-11-13?
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
2015-11-132016-01-15?Report of Comments
TC 65
TC 66
TC 76
TC 108
62A/1066/RVC

Result of voting on 62A/1013/CDV - IEC 82304-1: Health Software - Part 1: General requirements for product safety
2015-11-13yes
62A/1067/DC

Systematic Review of ISO 14971:2007, Medical devices - Application of risk management to medical devices
2015-11-132016-03-11Report of Comments
62A/1038A/CC

Revised compilation of comments on 62A/1011/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
2015-11-06no
62A/1063/CC

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
2015-10-30?
62A/1064/INF

Liaison report - Report from CLC/TC 62 to IEC/TC 62 and Subcommittees
2015-10-30
62A/1020A/DA

Revised draft agenda for the meeting to be held in Kobe, Japan on 2015-11-10 (starting time: 13:00 to approximate finishing time: 17:00) and 2015-11-11 (Starting time: 09:00 to approximate finishing time: 12:00)
2015-10-09
62A/1051/PW

Programme of work of the subcommittee as recorded by IEC Central Office in its database
2015-10-09
62A/1052/INF

Secretariat s view of the programme of work of the subcommittee (Agenda item 7.1)
2015-10-09
62A/1053/CC

Compilation of comments on 62A/1029/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
2015-10-09?
62A/1054/RQ

Results of Questionnaire 62A/1030/Q: IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance
2015-10-09
62A/1055/RQ

Results of Questionnaire on 62A/1031/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
2015-10-09
62A/1056/RQ

Results of Questionnaire 62A/1032/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
2015-10-09
62A/1057/RQ

Results of Questionnaire 62A/1033/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 systems
2015-10-09
62A/1058/RQ

Results of Questionnaire 62A/1034/Q: 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
2015-10-09
62A/1059/RQ

Results of Questionnaire 62A/1035/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
2015-10-09
62A/1060/RQ

Results of Questionnaire 62A/1036/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
2015-10-09
62A/1061/RQ

Results of Questionnaire 62A/1037/Q: 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
2015-10-09
62A/1062/INF

Review of Active Participation of P-members in the Work of SC 62A
2015-10-09
62A/1047/INF

Draft resolution proposed by the German National Committee of the IEC for consideration of the Kobe meeting of IEC/SC 62A
2015-09-25
62A/1048/INF

Confirmation of working group conveners (Agenda item 5.2)
2015-09-25
62A/1049/INF

Maintenance Cycle (Agenda item 6.9)
2015-09-25
62A/1050/INF

Report of the Secretariat - Covering activities of the Secretariat since the New Orleans meeting (2014-11-24) - Report as of 24 September 2015 (Agenda item 5.1)
2015-09-25
62A/1041A/INF

Revised report of comments and 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
2015-09-18
62A/1044/INF

Reports form the workings groups, maintenance teams and joint working groups of IEC/SC 62A for the November 2015 Subcommittee meeting in Kobe, Japan (Agenda item 5.3)
2015-09-18
62A/1045/INF

IEC/SC 62A liaison reports for the November 2015 Subcommittee meeting in Kobe, Japan (Agenda item 8.1)
2015-09-18
62A/1046/INF

Subcommittee 62A Liaison List
2015-09-18
62A/1042A/CC

Revised compilation of comments on 62A/1016/CD - ISO TR 80002-2: Medical device software - Part 2: Validation of software for regulated processes
2015-09-04no
62A/1043/RVC

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
2015-09-04no
62A/1042/CC

Compilation of comments on 62A/1016/CD - ISO TR 80002-2: Medical device software - Part 2: Validation of software for regulated processes
2015-08-28no
62A/999A/RVN

Revised result of voting on 62A/999/RVN: 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
2015-08-21?
62A/1038/CC

Compilation of comments on 62A/1011/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
2015-08-21no
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
2015-08-212015-10-23?Report of Comments
TC 65
TC 66
TC 76
TC 108
62A/1040/RVC

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
2015-08-21no
62A/1041/INF

This document has been cancelled and replaced by 62A/1041A/INF
2015-08-21
62A/1013/CDV

IEC 82304-1: Health Software - Part 1: General requirements for product safety
2015-07-312015-11-06yesVoting Result
TC 66
TC 76
62A/1020/DA

Draft agenda for the meeting to be held in Kobe, Japan on 2015-11-10 (starting time: 13:00 to approximate finishing time: 17:00) and 2015-11-11 (Starting time: 09:00 to approximate finishing time: 12:00)
2015-07-24
62A/1021/INF

Results of 62A/991/DC - Review of IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1022/INF

Results of 62A/992/DC - Review of 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1023/INF

Results of 62A/993/DC - Review of IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1024/INF

Results of 62A/994/DC - Review of 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 systems and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1025/INF

Results of 62A/995/DC - Review of 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1026/INF

Results of 62A/996/DC - Review of 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1027/INF

Results of 62A/997/DC - Review 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1028/INF

Results of 62A/998/DC - Review of 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1029/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
2015-07-242015-09-25?Report of Comments
TC 65
TC 66
TC 76
TC 108
62A/1030/Q

Questionnaire: IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1031/Q

Questionnaire: 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1032/Q

Questionnaire: IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1033/Q

Questionnaire: 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 systems - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1034/Q

Questionnaire: 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1035/Q

Questionnaire: 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1036/Q

Questionnaire: 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1037/Q

Questionnaire: 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02Report of Comments
62A/1019/INF

Publication of 30+ ENs in the field of medical electrical equipment in May 2015
2015-07-17
62A/952A/CC

Revised 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
2015-06-26no
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
2015-06-262015-08-28noVoting Result
TC 65
TC 66
TC 76
TC 108
62A/1016/CD

ISO TR 80001-2: Medical device software - Part 2: Validation of software for regulated processes
2015-06-192015-08-21noReport of Comments
TC 65
TC 66
TC 76
TC 108
62A/1017/INF

ISO Preliminary Work Item to revise ISO/TR 11633-1
2015-06-19
62A/1015/DTR

IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
2015-06-122015-08-14noVoting Result
TC 66
TC 76
TC 108
62A/1006A/CC

Revised compilation of comments on 62A/986/CD - IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
2015-05-29no
62A/1014/RVD

Report of voting on 62A/1007/FDIS - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2015-05-29yes
62A/930B/CC

Revised compilation of comments on 62A/913/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety
2015-05-22yes
62A/1012/INF

Report of IEC/SC 62A-ISO/TC 215 Joint Working Group 7 May 2015
2015-05-15
62A/987A/CC

Revised compilation of comments on 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
2015-05-08no
62A/1000A/INF

Amended report of comments and comments on 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
2015-05-08
62A/1009/INF

Final report - Health Software Ad hoc Group Report - April 2015 - Health Software and Health IT Safety Standards - FUTURE STATE Architecture/Framework and Roadmap and Related actions taken at the April 2015 meeting of ISO/TC 215
2015-05-08
62A/1010/DC

Draft revision of ISO/IEC Guide 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
2015-05-082015-08-14Report of Comments
62A/1011/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
2015-05-082015-08-14noReport of Comments
TC 66
TC 76
TC 77
TC 108