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

SC 62D

Electromedical equipment

 
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Other Documents SC 62D since 2018-08-18

Reference, Title
Downloads

Circulation

Date

Closing

Date

CENELEC

Voting /

Comment

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
62B/1146/RVD

Result of Voting on 62B/1137/FDIS - IEC 60601-2-43/AMD2 ED2: Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

2019-08-16 Y
76/639/CC

Compilation of Comments on 76/627/CD - IEC TR 62471-4 ED1: Photobiological Safety of Lamps and Lamp Systems - Part 4: Measuring Methods

2019-08-16 N
76/640/DTR

IEC TR 60825-8 ED3: Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans

2019-08-16 2019-10-11 N
ACEA/266/DC

WORKING DRAFT FOR COMMENT: Guidelines for defining halogen content terminology in IEC publications

2019-07-19 2019-09-27 N/A
3/1414/RVD

Result of Voting on 3/1404/FDIS - IEC 61293 ED2: Marking of electrical equipment with ratings related to electrical supply - Safety requirements

2019-07-19 Y
47/2587/RVC

Result of Voting on 47/2524/CDV - IEC 62779-4 ED1: Semiconductor devices - Semiconductor interface for human body communication- Part 4: Semiconductor interface for capsule endoscopy using human body communication

2019-07-19 Y
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
76/634/CC

Compilation of Comments on 76/609/CD - IEC TR 60825-8 ED3: Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans

2019-07-19 N
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
62A/1319A/CC

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

2019-07-05 Y
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
111/536/FDIS

IEC 62430 ED2: Environmentally conscious design (ECD) - Principles, requirements and guidance

2019-07-05 2019-08-16 Y Voting Result
29/1019A/RVDTR

Result of Voting on 29/1015/DTR - IEC TR 62809 ED2: Summary of requirements and tests to products in the scope of IEC 60601-2-66

2019-06-14 N
62B/1137/FDIS

IEC 60601-2-43/AMD2 ED2: Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

2019-06-14 2019-07-26 Y Voting Result
65/754/DC

Profiles on IEC 62443 Standards - Document for comments

2019-06-14 2019-07-26 N/A Report of Comments
65/755/INF

Report of comments with resolutions on 65/696/DC, Security for industrial automation and control systems - Part 2-1: Security program requirements for IACS asset owners

2019-06-14 N/A
3/1404/FDIS

IEC 61293 ED2: Marking of electrical equipment with ratings related to electrical supply - Safety requirements

2019-05-31 2019-07-12 Y Voting Result
62B/1106A/RVC

Revised result of Voting on 62B/1074/CDV - IEC 60601-2-43/AMD2 ED2: Amendment 2 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

2019-05-31 Y
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
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
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
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
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
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
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
66/696/RR

Review report on IEC 61010-2-040 Ed.2 : Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

2019-05-24 Y
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
62A/1330/FDIS

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

2019-05-10 2019-06-21 E Voting Result
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
76/611A/CC

Compilation of Comments on 76/589A/CD - IEC TR 62471-4 ED1: Photobiological Safety of Lamps and Lamp Systems: Measuring Methods

2019-05-10 N
76/627/CD

IEC TR 62471-4 ED1: Photobiological Safety of Lamps and Lamp Systems - Part 4: Measuring Methods

2019-05-10 2019-08-02 N Report of Comments
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
106/491/RQ

Report on questionnaire 106/481/Q - Proposal of AHG 6 for a concept paper for a guide to the drafting of publications related to the electromagnetic fields exposure compliance assessment

2019-04-19 N/A
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
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
1/2395/DC

Maintenance of IEC 60050-113 International Electrotechnical Vocabulary – Part 113: Physics for electrotechnology

2019-03-29 2019-05-10 N/A Report of Comments
3C/2368/INF

Report of comments and votes on 3C/2362/DC: Validation of Change Request to IEC 60417 (C00495)

2019-03-29 N/A
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
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
111/515/CDV

IEC 62321-10 ED1: Determination of certain substances in electrotechnical products - Part 10: Polycyclic aromatic hydrocarbons (PAHs) in polymers and electronics by gas chromatography-mass spectrometry (GC-MS)

2019-03-22 2019-06-14 Y Voting Result
111/522/RVC

Result of Voting on 111/484/CDV - IEC 62959 ED1: Environmentally Conscious Design (ECD) - Principles, requirements and guidance

2019-03-22 Y
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
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 U
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
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
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
3C/2359/INF

Compilation of comments on 3C/2349/DC: Evaluation of Change Request to IEC 60417 and directly on IEC 60417-C00495

2019-02-01 N/A
3C/2362/DC

Validation of Change Request to IEC 60417 (C00495)

2019-02-01 2019-03-15 N/A Report of Comments
62C/737/RVDTR

Result of Voting on 62C/729/DTR - IEC TR 62926 ED1: Medical electrical system - Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy

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

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

2019-01-18 2019-03-15 Y Report of Comments
3/1392/RVC

Result of Voting on 3/1357/CDV - IEC 61293 ED2: Marking of electrical equipment with ratings related to electrical supply - Safety requirements

2019-01-11 Y
29/1015/DTR

IEC TR 62809 ED2: Summary of requirements and tests to products in the scope of IEC 60601-2-66

2019-01-11 2019-03-08 N Voting Result
47/2524/CDV

IEC 62779-4 ED1: Semiconductor devices - Semiconductor interface for human body communication- Part 4: Semiconductor interface for capsule endoscopy using human body communication

2019-01-11 2019-04-05 Y Voting Result
62A/1276A/RVC

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

2019-01-11 Y
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
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
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
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
3C/2349/DC

Evaluation of Change Request to IEC 60417 (C00495)

2018-11-23 2019-01-18 N/A Report of Comments
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
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
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.

2018-10-26 2019-01-18 Y Report of Comments
62A/1275A/CC

Compilation of Comments on 62A/1256/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.

2018-10-19 Y
29/1007/RR

Review report of IEC TR 62809:2013 ED1: Summary of requirements and tests to products in the scope of IEC 60601-2-66

2018-10-12 N
62A/1288/CDV

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

2018-10-12 2019-01-04 Y Voting Result
62A/1261A/CC

Compilation of Comments on 62A/1237/CD - IEC 60601-1/AMD2 ED3: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2018-09-14 Y
62C/729/DTR

IEC TR 62926 ED1: Medical electrical system - Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy

2018-08-24 2018-10-19 N Voting Result