SC 62A

Common aspects of electrical equipment used in medical practice

 
export to xls file

SC 62A Working Documents since 2020-02-28

Reference, Title
Downloads

Circulation

Date

Closing

Date

CENELEC

Voting /

Comment

Of interest to

Committees

62A/1439/RQ

Result of Questionnaire (62A/1425/Q): National Committee feedback needed on proposed Interpretation Sheet for clauses 4.3 and 4.7 in IEC 60601-1(Follow up to 62A/1403/DISH)

2021-02-26 N/A
62A/1434/FDIS

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

2021-02-12 2021-03-26 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/1435/RVD

Result of Voting on 62A/1428/FDIS - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts

2021-02-12 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/1436/RR

Review of IEC TR 80001-2-8 ED1: 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 TR 80001-2-2

2021-02-12 U
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 108
62A/1437/RR

Review report of IEC TR 80001-2-2 ED1: Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

2021-02-12 U
62A/1438/DC

Document for Comments: Revision to start: IEC 62366-2:2016, Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

2021-02-12 2021-04-09 N/A
62A/1432/INF

Result of 62A/1426/DC on IEC 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 TR 80001-2-2 -  Comments on proposed revision

2021-01-15 N/A
62A/1433/INF

Result of 62A/1427/DC on IEC 80001-2-2, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls – Comments on proposed revision

2021-01-15 N/A
62A/1422(F)/CDV

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

2021-01-08 2021-03-26 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1424/CDV

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

2021-01-08 2021-04-02 Y
TC 56
SC 62B
SC 62C
SC 62D
62A/1431/DC

IEC 62/374/DC describing proposal for a new subcommittee in TC62 :Feedback from 62A P-members will be helpful for discussion at April plenary meeting

2021-01-08 2021-02-19 N/A Report of Comments
62A/1422/CDV

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

2021-01-01 2021-03-26 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1423A/INF

Updated Information regarding the revision of IEC 62304, Health software – Software life cycle processes -  IMPORTANT – Virtual Sessions to be held on 8 and 9 December 2020

2020-12-18 N/A
62A/1428/FDIS

ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts

2020-12-18 2021-01-29 E Voting Result
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/1430/DA

Draft agenda for the meeting to be held virtually,from 2021-04-15 (starting time: 11:00 UTC) to (approximate finishing time: 14:00 UTC) - (11:00 UTC corresponds to 13:00 Central European time, 07:00 U.S. Eastern time and 20:00Japan time

2020-12-18 N/A
62A/1429/NP

PNW TS 62A-1429 ED1: Safe, effective, and secure health software and health IT systems - Assurance cases
Application guidance — Guidance for the use of assurance cases – safety & security

2020-12-04 2021-02-26 U Voting Result
62A/1398A/RVC

Revised Result of Voting on 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

2020-11-27 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/1419/CDV

IEC 81001-5-1 ED1: Health Software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle

2020-11-27 2021-02-19 Y Voting Result
TC 62
SC 62B
SC 62C
SC 62D
62A/1426/DC

Document for comments: IEC TR 80001-2-8:2016Application 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 TR 80001-2-2

2020-11-27 2021-01-08 N/A Report of Comments
62A/1427/DC

Document for Comments - IEC TR 80001-2-2:2012Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

2020-11-27 2021-01-08 N/A Report of Comments
62A/1425/Q

National Committee feedback needed on proposed Interpretation Sheet for clauses 4.3 and 4.7 in IEC 60601-1 - (Follow up to 62A/1403/DISH)

2020-11-20 2021-01-08 N/A Report of Comments
62A/1399A/RVC

Revised Result of Voting on 62A/1379/CDV - 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

2020-11-13 Y
TC 56
SC 62B
SC 62C
SC 62D
62A/1423/INF

Information regarding the revision of IEC 62304, Health software – Software life cycle processes -  IMPORTANT – Virtual Sessions to be held on 8 and 9 December 2020

2020-11-13 N/A
62A/1374A/RVN

Revised Result of Voting on 62A/1343/NP - PNW TS 62A-1343: Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice

2020-10-30 N
62A/1420/INF

Background information on IEC/ISO 81001-5-1 - “Security Activities in The Product Lifecycle”

2020-10-30 N/A
62A/1421/INF

Results on the Document for Comment (62A/1401/DC): National Committee feedback needed on IEC 63120 - Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

2020-10-30 N/A
62A/1417A/RVDTR

Revised Result of Voting on 62A/1402/DTR - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

2020-10-09 N
62A/1417/RVDTR

Result of Voting on 62A/1402/DTR - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

2020-08-28 N
62A/1418/RQ

Result of Questionnaire on 62A/1412/Q: National Committee feedback needed on proposed renumbering and updated title for international standard on security activities in the health software life cycle (IEC 80001-5-1 to IEC 81001-5-1)

2020-08-28 N/A
62A/1383B/RVC

Revised Result of Voting on 62A/1349/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes

2020-08-14 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1414/RVDISH

Result of Voting on 62A/1403/DISH - IEC 60601-1/AMD1/ISH1 ED3: Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2020-08-14 E
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1415/INF

Call for experts to Working Group TC 62/WG 4 Terminology

2020-08-14 N/A
62A/1416/INF

Nominations to the Software Network and Artificial Intelligence Advisory Group (AG SNAIG) of TC 62

2020-08-14 N/A
62A/1413/INF

IEC TC 62/ISO TC 210 Joint Advisory Group on Life Cycle Aspects for Medical Devices

2020-08-07 N/A
62A/1383A/RVC

Revised Result of Voting on 62A/1349/CDV - IEC 62304 Ed. 2: Health software - Software life cycle processes

2020-07-24 Y
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 106
TC 108
62A/1385A/RVC

Revised Result of Voting on 62A/1370/CDV - ISO 81001-1 ED1: Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

2020-07-10 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/1412/Q

Questionnaire - National Committee feedback needed on proposed renumbering and updated title for international standard on security activities in the health software life cycle (IEC 80001-5-1 to IEC 81001-5-1)

2020-07-10 2020-08-21 N/A Report of Comments
62A/1404/RVD

Result of Voting on 62A/1389/FDIS - IEC 60601-1/AMD2 ED3: Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1405/RVD

Result of Voting on 62A/1390/FDIS - 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

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1406/RVD

Result of Voting on 62A/1391/FDIS - 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

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1407/RVD

Result of Voting on 62A/1392/FDIS - 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

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1408/RVD

Result of Voting on 62A/1393/FDIS - IEC 60601-1-9/AMD2 ED1: Amendment 2 - Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

2020-06-26 Y
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1409/RVD

Result of Voting on 62A/1394/FDIS - 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

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1410/RVD

Result of Voting on 62A/1395/FDIS - 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

2020-06-26 Y
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
TC 106
TC 108
62A/1411/RVD

Result of Voting on 62A/1396/FDIS - IEC 60601-1-12/AMD1 ED1: Amendment 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

2020-06-26 Y
ACEA
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/1402/DTR

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

2020-06-19 2020-08-14 N Voting Result
62A/1403/DISH

IEC 60601-1/AMD1/ISH1 ED3: Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2020-06-19 2020-07-31 E Voting Result
TC 62
SC 62B
SC 62C
SC 62D
TC 66
TC 76
62A/1400A/CC

Revised Compilation of Comments on 62A/1384/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

2020-06-12 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1387A/CC

Revised Compilation of Comments on 62A/1380/CD - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

2020-05-15 N
62A/1391(F)/FDIS

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

2020-05-15 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/1393(F)/FDIS

IEC 60601-1-9/AMD2 ED1: Amendment 2 - Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

2020-05-15 Y Voting Result
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1395(F)/FDIS

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

2020-05-15 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/1399/RVC

Result of Voting on 62A/1379/CDV - 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

2020-05-15 Y
TC 56
SC 62B
SC 62C
SC 62D
62A/1400/CC

Compilation of Comments on 62A/1384/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

2020-05-15 Y
TC 62
SC 62B
SC 62C
SC 62D
62A/1401/DC

Document for comments: National Committee feedback needed on IEC 63120 - Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

2020-05-15 2020-06-26 N/A Report of Comments
62A/1394(F)/FDIS

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

2020-05-08 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/1396(F)/FDIS

IEC 60601-1-12/AMD1 ED1: Amendment 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

2020-05-08 Y Voting Result
ACEA
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/1397/RVD

Result of Voting on 62A/1386/FDIS - IEC 62366-1/AMD1 ED1: Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices

2020-05-08 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/1398/RVC

Result of Voting on 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

2020-05-01 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/1164D/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))

2020-04-24 N/A
62A/1166E/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)

2020-04-24 N/A
62A/1168C/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)

2020-04-24 N/A
62A/1170E/INF

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)

2020-04-24 N/A
62A/1172D/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)

2020-04-24 N/A
62A/1174D/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)

2020-04-24 N/A
62A/1389/FDIS

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

2020-04-24 2020-06-05 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/1390/FDIS

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

2020-04-24 2020-06-05 Y Voting Result
SC 22E
TC 62
SC 62B
SC 62C
SC 62D
TC 65
TC 66
TC 76
TC 77
CIS/B
62A/1391/FDIS

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

2020-04-24 2020-06-05 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/1392/FDIS

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

2020-04-24 2020-06-05 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/1393/FDIS

IEC 60601-1-9/AMD2 ED1: Amendment 2 - Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

2020-04-24 2020-06-05 Y Voting Result
ACEA
SC 22E
TC 65
TC 66
TC 76
TC 77
TC 85
TC 106
TC 108
TC 111
CIS/B
62A/1394/FDIS

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

2020-04-24 2020-06-05 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/1395/FDIS

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

2020-04-24 2020-06-05 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/1396/FDIS

IEC 60601-1-12/AMD1 ED1: Amendment 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

2020-04-24 2020-06-05 Y Voting Result
ACEA
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/1388/INF

ISO/TC 210 New Work Item Proposal - For Information. Proposal for a new Standard, Active medical device – Good engineering maintenance management

2020-04-03 N/A
62A/1387/CC

Compilation of Comments on 62A/1380/CD - IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

2020-03-13 N
62A/1386/FDIS

IEC 62366-1/AMD1 ED1: Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices

2020-02-28 2020-04-10 Y Voting Result
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