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

SC 62B

Diagnostic imaging equipment

 
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Other Documents SC 62B since 2019-09-20

Reference, Title
Downloads

Circulation

Date

Closing

Date

CENELEC

Voting /

Comment

62C/764A/CC

Revised Compilation of Comments on 62C/745/CD - IEC 62083 ED3: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

2020-08-28 Y
62C/782/RR

Review report of IEC 61267 ED2: Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics

2020-08-28 Y
25/700/CC

Compilation of Comments on 25/696/CD - IEC 80000-17 ED1: Quantities and units - Part 17: Time dependency

2020-08-14 Y
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
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
62C/770/FDIS

IEC 60601-2-1 ED4: Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

2020-08-07 2020-09-18 Y Voting Result
62C/773/RR

Review report of IEC 60601-2-68 ED1: Electrical medical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

2020-08-07 Y
62C/774/CD

IEC 60601-2-68/AMD1 ED1: Amendment 1 - Electrical medical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

2020-08-07 2020-10-02 Y
62C/778/CD

IEC 61217 ED3: Radiotherapy equipment - Coordinates, movements and scales

2020-08-07 2020-10-30 Y
62C/768/RR

Review report of IEC 61217 ED2: Radiotherapy equipment - Coordinates, movements and scales

2020-07-24 Y
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
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
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
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
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
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
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
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
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
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
106/520/RVD

Result of Voting on 106/514/FDIS - IEC/IEEE 62209-1528 ED1: Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from hand-held and body-worn wireless communication devices - Part 1528: Human models, instrumentation and procedures (Frequency range of 4 MHz to 10 GHz)

2020-06-05 U
106/521/RVD

Result of Voting on 106/515/FDIS - IEC/IEEE 62704-4 ED1: Determining the peak spatial-average specific absorption rate (SAR) in the human body from wireless communications devices, 30 MHz to 6 GHz - General requirements for using the finite-element method (FEM) for SAR calculations

2020-06-05 N
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
25/695/RR

Review report on IEC 60027-1 Ed6: Letters symbols to be used in electrical technology - Part 1: General

2020-05-08 Y
25/696/CD

IEC 80000-17 ED1: Quantities and units - Part 17: Time dependency

2020-05-08 2020-07-31 Y Report of Comments
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
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
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
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
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
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
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
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
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
106/517/CC

Compilation of Comments on 106/511/CD - IEC 62232 ED3: Determination of RF field strength, power density and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

2020-04-24 Y
111/577/RVD

Result of Voting on 111/573/FDIS - IEC 62321-3-2 ED2: Determination of certain substances in electrotechnical products - Part 3-2: Screening - Fluorine, bromine and chlorine in polymer and electronics by combustion-ion chromatography (C-IC)

2020-04-17 Y
106/514/FDIS

IEC/IEEE 62209-1528 ED1: Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from hand-held and body-worn wireless communication devices - Part 1528: Human models, instrumentation and procedures (Frequency range of 4 MHz to 10 GHz)

2020-04-10 2020-05-22 U Voting Result
106/515/FDIS

IEC/IEEE 62704-4 ED1: Determining the peak spatial-average specific absorption rate (SAR) in the human body from wireless communications devices, 30 MHz to 6 GHz - General requirements for using the finite-element method (FEM) for SAR calculations

2020-04-10 2020-05-22 N Voting Result
106/516/RR

Review Report on IEC/IEEE 62704-1: Determining the peak spatial-average specific absorption rate (SAR) in the human body from wireless communications devices, 30 MHz to 6 GHz - Part 1: General requirements for using the finite difference time-domain (FDTD) method for SAR calculations

2020-04-03 U
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
111/573/FDIS

IEC 62321-3-2 ED2: Determination of certain substances in electrotechnical products - Part 3-2: Screening - Fluorine, bromine and chlorine in polymer and electronics by combustion-ion chromatography (C-IC)

2020-02-28 2020-04-10 Y Voting Result
62A/1375A/CC

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

2020-01-31 Y
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

2020-01-31 2020-04-24 Y Voting Result
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

2020-01-31 2020-04-24 Y Report of Comments
106/512/RR

Review Report of IEC PAS 63151 Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Vector measurement-based systems (Frequency range of 30 MHz to 6 GHz)

2020-01-31 U
62A/1350A/RVC

Revised 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

2020-01-24 Y
62A/1351A/RVC

Revised 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.

2020-01-24 Y
62A/1353A/RVC

Revised 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

2020-01-24 Y
62A/1354A/RVC

Revised 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

2020-01-24 Y
62A/1356A/RVC

Revised 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

2020-01-24 Y
62A/1357A/RVC

Revised 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

2020-01-24 Y
62A/1358A/RVC

Revised 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

2020-01-24 Y
106/507/CDV

IEC/IEEE 63195-1 ED1: Measurement procedure for the assessment of power density of human exposure to radio frequency fields from wireless devices operating in close proximity to the head and body – Frequency range of 6 GHz to 300 GHz

2020-01-24 2020-04-17 U Voting Result
106/508/CDV

IEC/IEEE 63195-2 ED1: Determining the power density of the electromagnetic field associated with human exposure to wireless devices operating in close proximity to the head and body using computational techniques, 6 GHz to 300 GHz

2020-01-24 2020-04-17 U Voting Result
106/511/CD

IEC 62232 ED3: Determination of RF field strength, power density and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

2019-12-20 2020-03-13 Y Report of Comments
62A/1345A/RVDTR

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

2019-12-13 E
62A/1376/CC

Compilation of Comments on 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

2019-12-13 Y
106/487A/CC

Compilation of Comments on 106/476/CD - IEC/IEEE 63195 ED1: Measurement procedure for the assessment of power density of human exposure to radio frequency fields from wireless devices operating in close proximity to the head and body – Frequency range of 6 GHz to 300 GHz

2019-12-06 U
106/489B/CC

Compilation of Comments on 106/478/CD - IEC/IEEE 62704-5 ED1: Determining the power density of the electromagnetic field associated with human exposure to wireless devices operating in close proximity to the head and body using computational techniques, 6 GHz to 300 GHz

2019-12-06 U
25/692/CD

ISO 80000-1 ED2: Quantities and units - Part 1: General

2019-11-29 2020-01-24 N Report of Comments
62A/1370/CDV

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

2019-11-15 2020-02-07 E Voting Result
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 Voting Result
106/485B/RVC

Result of Voting on 106/469/CDV - IEC/IEEE 62704-4 ED1: Recommended practise for determining the Peak Spatial Average Specific Absorption Rate (SAR) in the human body from wireless communications devices, 30 MHz - 6 GHz: General requirements for using the Finite-Element Method (FEM) for SAR calcutaions and specific requirements for modelling vehicle-mounted antennas and personal wireless devices

2019-11-01 N
62C/751/RVD

Result of Voting on 62C/744/FDIS - IEC 60580 ED3: Medical electrical equipment - Dose area product meters

2019-10-25 Y
62A/1349/CDV

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

2019-10-04 2019-12-27 Y Voting Result