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 2018-11-15

Reference, Title
Downloads

Circulation

Date

Closing

Date

CENELEC

Voting /

Comment

Of interest to

Committees

62A/1359/CDV

IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

2019-11-01 2020-01-24 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1371/DL

List of decisions taken at the meeting of SC 62A, held in Shanghai, China on 22 October 2019

2019-11-01 N/A
62A/1349/CDV

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

2019-10-04 2019-12-27 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1342A/DA

Revised draft agenda for the meeting to be held in Shanghai, China on 2019-10-22 (starting time: 14:00 to approximate finishing time: 17:00)

2019-09-20 N/A
62A/1361/INF

Report of the Secretariat (Agenda item 5.1)

2019-09-20 N/A
62A/1362/INF

Confirmation of working group conveners (Agenda Item 5.2)

2019-09-20 N/A
62A/1363/INF

Reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A for the October 2019 Subcommittee in Shanghai, China (Agenda item 5.3)

2019-09-20 N/A
62A/1364/INF

Status report on the development/finalization of the Amendment projects (Agenda item 6.1)

2019-09-20 N/A
62A/1365/INF

Report of voting on the CDV/DIS stage for the Amendment projects (Agenda item 6.2)

2019-09-20 N/A
62A/1366/INF

Secretariat’s view of the programme of work of the subcommittee (Agenda item 7.1)

2019-09-20 N/A
62A/1367/INF

Maintenance Cycle (Agenda item 7.2)

2019-09-20 N/A
62A/1368/INF

IEC/SC 62A Liaison Reports for the October meeting 2019 of the Subcommittee in Shanghai, China (Agenda item 8.1)

2019-09-20 N/A
62A/1369/INF

Subcommittee 62A Liaison List (Agenda item 8.2)

2019-09-20 N/A
62A/1353/RVC

Result of Voting on 62A/1324/CDV - IEC 60601-1-6/AMD2 ED3: Amendment 2 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1354/RVC

Result of Voting on 62A/1325/CDV - IEC 60601-1-8/AMD2 ED2: Amendment 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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1355/RVC

Result of Voting on 62A/1326/CDV - IEC 60601-1-9/AMD2 ED1: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

2019-09-13 Y
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1356/RVC

Result of Voting on 62A/1327/CDV - IEC 60601-1-10/AMD2 ED1: Amendment 2 – 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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1357/RVC

Result of Voting on 62A/1328/CDV - IEC 60601-1-11/AMD1 ED2: Amendment 1 – 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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1358/RVC

Result of Voting on 62A/1329/CDV - IEC 60601-1-12/AMD1 ED1: 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

2019-09-13 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1360/CD

IEC 80001-5-1 ED1: Safety, security and effectiveness in the implementation and use of connected medical devices or connected health software - Part 5-1: Security - Activities in the product lifecycle

2019-09-13 2019-11-08 Y Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
62A/1352/INF

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

2019-09-06 N/A
62A/1315B/CC

Compilation of Comments on 62A/1302/CD - IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

2019-08-30 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1317A/CC

Compilation of Comments on 62A/1308/CD - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

2019-08-30 E
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1350/RVC

Result of Voting on 62A/1320/CDV - IEC 60601-1/AMD2 ED3: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2019-08-30 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1351/RVC

Result of Voting on 62A/1321/CDV - IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

2019-08-30 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1315A/CC

Compilation of Comments on 62A/1302/CD - IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

2019-08-16 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1348/Q

Questionnaire: National Committee feedback needed regarding proposed CEN lead on 62A/1343/NP Health software – Part 2: Health and wellness apps – Quality criteria across the life cycle – Code of practice

2019-08-09 2019-09-20 N/A Report of Comments
62A/1309A/RVC

Result of Voting on 62A/1288/CDV - IEC 62366-1/AMD1 ED1: Medical devices - Part 1: Application of usability engineering to medical devices

2019-07-19 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1346/Q

National Committee feedback needed regarding possible new work - Of Interest to IEC/SC 62A - Safety of intended performances

2019-07-19 2019-08-30 N/A Report of Comments
62A/1347/INF

Information about the attached Document (62/333/DC) for comments on architecture aspects of safety standards for medical electrical equipment, medical electrical systems, and software used in healthcare

2019-07-19 N/A
62A/1345/RVDTR

Result of Voting on 62A/1331/DTR - ISO TR 24971 ED2: Medical devices -- Guidance on the application of ISO 14971

2019-07-12 E
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1319A/CC

Compilation of Comments on 62A/1310/CD - IEC 62304 Ed. 2: Health software - Software life cycle processes

2019-07-05 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1343/NP

PNW TS 62A-1343: Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice

2019-07-05 2019-09-27 N Voting Result
62A/1344/RVD

Result of Voting on 62A/1330/FDIS - ISO 14971 ED3: Medical devices - Application of risk management to medical devices

2019-07-05 E
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1342/DA

Draft agenda for the meeting to be held in Shanghai, China on 2019-10-22 (starting time: 14:00 to approximate finishing time: 17:00)

2019-06-21 N/A
62A/1341/CD

IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

2019-06-07 2019-09-27 N Report of Comments
62A/1164C/INF

Design Specification for Amendment 2 to IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Revision 3))

2019-05-24 N/A
62A/1166D/INF

Design Specification for Amendment 1 to IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests (Revision 4)

2019-05-24 N/A
62A/1168B/INF

Design Specification for Amendment 2 to IEC 60601-1-6:2010 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (Revision 2)

2019-05-24 N/A
62A/1170D/INF

Updated design Specification for Amendment 2 to IEC 60601-1-8:2006 - 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 (Revision 4)

2019-05-24 N/A
62A/1172C/INF

Design Specification for Amendment 2 to IEC 60601-1-10:2007 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 (Revision 3)

2019-05-24 N/A
62A/1174C/INF

Design Specification for Amendment 1 to IEC 60601-1-11:2015 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 (Revision 3)

2019-05-24 N/A
62A/1320/CDV

IEC 60601-1/AMD2 ED3: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1321/CDV

IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1324/CDV

IEC 60601-1-6/AMD2 ED3: Amendment 2 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1325/CDV

IEC 60601-1-8/AMD2 ED2: Amendment 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

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1326/CDV

IEC 60601-1-9/AMD2 ED1: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1327/CDV

IEC 60601-1-10/AMD2 ED1: Amendment 2 – 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

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1328/CDV

IEC 60601-1-11/AMD1 ED2: Amendment 1 – 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

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1329/CDV

IEC 60601-1-12/AMD1 ED1: 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

2019-05-24 2019-08-16 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1333/INF

Informative document- Working draft of IEC 60601-1 Ed.3.2: Medical electrical equipment – Part 1: General requirements for safety and essential performance - Companion document to 62A/1320/CDV

2019-05-24 N/A
62A/1334/INF

Informative document - Working draft of IEC 60601-2 Ed.4.1: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests - Companion document to 62A/1321/CDV

2019-05-24 N/A
62A/1335/INF

Informative document - Working draft of IEC 60601-1-6 Ed.3.2: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability - Companion document to 62A/1324/CDV

2019-05-24 N/A
62A/1336/INF

Informative document - Working draft of IEC 60601-1-8 Ed.2.2: 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 - Companion document 62A/1325/CDV

2019-05-24 N/A
62A/1337/INF

Informative document - Working Draft of IEC 60601-1-9 Ed.1.2: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design - Companion document to 62A/1326/CDV

2019-05-24 N/A
62A/1338/INF

Informative document - Working Draft of IEC 60601-1-10 Ed.1.2. 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 - Companion document to 62A/1327/CDV

2019-05-24 N/A
62A/1339/INF

Informative document - Working Draft of IEC 60601-1-11 Ed.2.1: 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 - Companion document to 62A/1328/CDV

2019-05-24 N/A
62A/1340/INF

Informative document - working Draft of IEC 60601-1-12 Ed.1.1: 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 - Companion document to 62A/1329/CDV

2019-05-24 N/A
62A/1332/CD

IEC 63120 ED1: Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

2019-05-17 2019-08-09 Y Report of Comments
TC 56
SC 62B
SC 62C
SC 62D
62A/1330/FDIS

ISO 14971 ED3: Medical devices - Application of risk management to medical devices

2019-05-10 2019-06-21 E Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1331/DTR

ISO TR 24971 ED2: Medical devices -- Guidance on the application of ISO 14971

2019-05-10 2019-07-05 E Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1297A/CC

Compilation of Comments on 62A/1284/CD - ISO TR 24971 ED2: Medical devices -- Guidance on the application of ISO 14971

2019-04-26 E
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1311A/CC

Compilation of Comments on 62A/1298/CD - IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

2019-04-05 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1322/RR

Review report of IEC 60601-1-9 ED1: Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

2019-04-05 Y
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1323/RR

Review report of IEC 60601-1-12 ED1: 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

2019-04-05 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1279A/CC

Compilation of Comments on 62A/1268/CD - IEC 60601-1-10/AMD2 ED1: Amendment 2 – 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

2019-03-29 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1314A/CC

Compilation of Comments on 62A/1303/CD - IEC 60601-1-8/AMD2 ED2: Amendment 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

2019-03-29 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1318/INF

Results of the National Committee Enquiry in roposal from the Ad Hoc Group 62368-60601 on integration of the requirements of IEC 62368-1:2018 as an alternative approach to demonstrating MEANS OF OPERATOR PROTECTION - "Application of this standard on the incorporation of equipment complying with IEC 62368-1:2018 into ME EQUIPMENT and ME SYSTEMS"

2019-03-22 N/A
62A/1319/CC

Compilation of Comments on 62A/1310/CD - IEC 62304 Ed. 2: Health software - Software life cycle processes

2019-03-22 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1317/CC

Compilation of Comments on 62A/1308/CD - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

2019-03-15 E
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1290A/RVN

Result of Voting on 62A/1277/NP - PNW 62A-1277: Application of risk management for IT-networks incorporating medical device – Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 5-1: Activities in the product lifecycle

2019-03-01 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1316/RQ

Result of Questionnaire on 62A/1306/Q: Nomination of convenor of IEC/SC 62A/MT 28, Electrical hazards

2019-03-01 N/A
62A/1296A/RVC

Result of Voting on 62A/1282/CDV - ISO 14971 ED3: Medical devices - Application of risk management to medical devices

2019-02-22 E
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1315/CC

Compilation of Comments on 62A/1302/CD - IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

2019-02-22 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1224A/CC

Compilation of Comments on 62A/1204/CD - IEC 60601-1-6/AMD2 ED3: Amendment 2 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

2019-02-15 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1262A/CC

Compilation of Comments on 62A/1239/CD - IEC 60601-1-11/AMD1 ED2: Amendment 1 – 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

2019-02-15 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1314/CC

Compilation of Comments on 62A/1303/CD - IEC 60601-1-8/AMD2 ED2: Amendment 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

2019-02-08 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1313/INF

Result of ISO/IEC Guide 63 vote– Of Interest to IEC/SC 62A - Guide to the development and inclusion of aspects of safety in International Standards for medical devices

2019-02-01 N/A
62A/1305A/RQ

Revised result of Questionnaire on 62A/1300/Q: Questionnaire on NC feedback needed regarding risk management process in the revision of IEC 62304, Health software – Software life cycle processes

2019-01-25 N/A
62A/1311/CC

Compilation of Comments on 62A/1298/CD - IEC 60601-1-2/AMD1 ED4: Amendment 1 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

2019-01-25 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1312/INF

ISO/TC 210 Draft Standard – Of Interest to IEC/SC 62A - ISO 20417: Medical devices – Requirements for general information to be provided by the manufacturer

2019-01-25 N/A
62A/1310/CD

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

2019-01-18 2019-03-15 Y Report of Comments
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1276A/RVC

Result of Voting on 62A/1235/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes

2019-01-11 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1292A/CC

Compilation of Comments on 62A/1283/CD - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

2019-01-11 E
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1305/RQ

Result of Questionnaire on 62A/1300/Q: Questionnaire on NC feedback needed regarding risk management process in the revision of IEC 62304, Health software – Software life cycle processes

2019-01-11 N/A
62A/1306/Q

Nomination of convenor of IEC/SC 62A/MT 28, Electrical hazards

2019-01-11 2019-02-22 N/A Report of Comments
62A/1307/INF

National Committees of SC 62A input needed on IEC 62B/1116/CDV – IEC 63077 Ed. 1: Good refurbishment practices for medical imaging

2019-01-11 N/A
62A/1308/CD

ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

2019-01-11 2019-03-08 E Report of Comments
SC 22E
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
CIS/B
62A/1309/RVC

Result of Voting on 62A/1288/CDV - IEC 62366-1/AMD1 ED1: Medical devices - Part 1: Application of usability engineering to medical devices

2019-01-11 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1170C/INF

Updated design Specification for Amendment 2 to IEC 60601-1-8:2006 - 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

2018-12-14 N/A
62A/1303/CD

IEC 60601-1-8/AMD2 ED2: Amendment 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

2018-12-07 2019-02-01 Y Report of Comments
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1304/INF

Informative document - Working Draft of IEC 60601-1-8 Ed. 2.2 - 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 - Companion document to 62A/1303/CD

2018-12-07 N/A
62A/1264A/CC

Compilation of Comments on 62A/1241/CD - IEC 60601-1-8/AMD2 ED2: Amendment 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

2018-11-30 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1302/CD

IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

2018-11-23 2019-02-15 Y Report of Comments
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1267A/CC

Compilation of Comments on 62A/1244/CD - IEC 80001-1 ED2: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

2018-11-16 Y
SC 23E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 85
TC 96
TC 106
TC 108
TC 111
62A/1301/DC

Document for comments: Proposal from the Ad Hoc Group 62368-60601 on integration of the requirements of IEC 62368-1:2018 as an alternative approach to demonstrating MEANS OF OPERATOR PROTECTION - "APPLICATION OF THIS STANDARD ON THE INCORPORATION OF EQUIPMENT COMPLYING WITH IEC 62368-1:2018 INTO ME EQUIPMENT AND ME SYSTEMS"

2018-11-16 2019-02-08 N/A Report of Comments