SC 62A

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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))

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)

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)

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)

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

Revised Compilation of Comments on 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

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

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

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