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 2018-08-23

Reference, Title
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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
106/497/RVD

Result of Voting on 106/494/FDIS - IEC 62209-3 ED1: 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 - Part 3: Vector measurement-based systems (Frequency range of 600 MHz to 6 GHz)

2019-08-16 Y
106/489A/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

2019-08-09 U
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
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
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
106/494/FDIS

IEC 62209-3 ED1: 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 - Part 3: Vector measurement-based systems (Frequency range of 600 MHz to 6 GHz)

2019-06-28 2019-08-09 Y Voting Result
62C/741/RVDTR

Result of Voting on 62C/738/DTR - IEC TR 63183 ED1: Guidance on error and warning messages for software used in radiotherapy

2019-06-21 N
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
106/475C/RVC

Result of Voting on 106/464/CDV - IEC/IEEE 62209-1528 ED1: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures: 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 (Frequency range of 4 MHz to 10 GHz)

2019-06-14 U
62C/739A/CC

Compilation of Comments on 62C/735/CD - IEC 62083 ED3: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

2019-06-07 Y
106/485A/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

2019-06-07 N
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
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
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
106/493/RVDTS

Result of Voting on 106/477/DTS - IEC TS 62764-1 ED1: Measurement procedures of magnetic field levels generated by electronic and electrical equipment in the automotive environment with respect to human exposure

2019-05-10 U
106/492/RVD

Result of Voting on 106/484/FDIS - IEC 62209-2/AMD1 ED1: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (frequency range of 30 MHz to 6 GHz)

2019-05-03 Y
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
106/488/RR

Review report on IEC 62232/Ed2: Determination of RF field strength, power density and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

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
106/486/RVD

Result of Voting on 106/480/FDIS - IEC 62311 ED2: Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz)

2019-03-22 Y
106/487/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

2019-03-22 U
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
106/482A/RVDTR

Result of Voting on 106/473/DTR - IEC TR 62669 ED2: Case studies supporting IEC 62232 - Determination of RF field strength and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

2019-03-08 N
106/484/FDIS

IEC 62209-2/AMD1 ED1: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (frequency range of 30 MHz to 6 GHz)

2019-03-08 2019-04-19 Y Voting Result
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/738/DTR

IEC TR 63183 ED1: Guidance on error and warning messages for software used in radiotherapy

2019-02-01 2019-03-29 N Voting Result
106/480/FDIS

IEC 62311 ED2: Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz)

2019-02-01 2019-03-15 Y Voting Result
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
62C/711B/RVC

Result of Voting on 62C/700/CDV - 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

2019-01-18 Y
62C/726A/CC

Compilation of Comments on 62C/713/CD - IEC TR 63183 ED1: RADIOTHERAPY SYSTEMS AND SOFTWARE – GUIDANCE ON ERROR AND WARNING MESSAGES

2019-01-18 N
62C/732/RR

Review report of IEC 62083 ED2: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

2019-01-18 Y
62C/733/RVDTR

Result of Voting on 62C/714/DTR - IEC TR 61948-2 ED2: Nuclear medicine instrumentation - Routine tests - Part 2: Scintillation cameras and single photon emission computed tomography imaging

2019-01-18 U
62C/735/CD

IEC 62083 ED3: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

2019-01-18 2019-03-15 Y Report of Comments
62C/736/RVC

Result of Voting on 62C/724/CDV - IEC 60580 ED3: Medical electrical equipment - Dose area product meters

2019-01-18 Y
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
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
106/474A/RVC

Result of Voting on 106/457/CDV - IEC 62209-3 ED1: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 3: Vector probe systems (Frequency range of 100 MHz to 6 GHz)

2018-12-28 Y
106/477/DTS

IEC TS 62764-1 ED1: Measurement procedures of magnetic field levels generated by electronic and electrical equipment in the automotive environment with respect to human exposure

2018-12-14 2019-03-08 U Voting Result
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

2018-12-14 2019-03-08 U 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
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

2018-12-07 2019-03-01 N Voting Result
106/473/DTR

IEC TR 62669 ED2: Case studies supporting IEC 62232 - Determination of RF field strength and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

2018-12-07 2019-02-01 N Voting Result
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

2018-12-07 2019-03-01 U 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
106/452B/CC

Compilation of Comments on 106/349/CD - IEC 62764-1: Measurement procedures of magnetic field levels generated by electronic and electrical equipment in the automotive environment with respect to human exposure

2018-11-30 U
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
106/471/RVC

Result of Voting on 106/460/CDV - IEC 62209-2/AMD1 ED1: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures - Part 2: Procedure to determine the specific absorption rate (SAR) for wireless communication devices used in close proximity to the human body (frequency range of 30 MHz to 6 GHz)

2018-11-02 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
106/467A/CC

Compilation of Comments on 106/463/CD - IEC TR 62669 ED2: Case studies supporting IEC 62232 - Determination of RF field strength and SAR in the vicinity of radiocommunication base stations for the purpose of evaluating human exposure

2018-10-19 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
106/384A/CC

Compilation of Comments on 106/371/CD - IEC/IEEE 62704-4 Ed.1: Recommended Practice for Determining the Peak Spatial Average Specific Absorption Rate (SAR) in the Human Body from Wireless Communications Devices, 30 MHz - 6 GHz - Part 4: General Requirements for Using the Finite-Element Method for SAR Calculations and Specific Requirements for Modelling Vehicle-Mounted Antennas and Personal Wireless Devices

2018-10-12 N
106/461A/RVC

Result of Voting on 106/439/CDV - IEC 62311 ED2: Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz - 300 GHz)

2018-09-21 Y
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
106/464/CDV

IEC/IEEE 62209-1528 ED1: Human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices - Human models, instrumentation, and procedures: 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 (Frequency range of 4 MHz to 10 GHz)

2018-09-07 2018-11-30 U Voting Result
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