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

SC 62D

Electromedical equipment

 
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Other Documents accessible to SC 62D since 2016-08-21

Reference, Title
Downloads

Circulation

Date

Closing

Date

CENELEC

Voting /

Comment

ACOS/853/INF

Details of ACOS workshop to be held in Tokyo, Japan, on 26 and 27 June 2017 – Safety considerations for next generation industrial automation

2017-04-14 N/A
1/2319/CDV

IEC 60050-871: International electrotechnical vocabulary - Part 871: Active assisted living (AAL)

2017-01-06 2017-03-31 N Voting Result
1/2337A/DC

Maintenance of IEC 60050-195 International Electrotechnical Vocabulary – Part 195 Earthing and protection against electric shock

2017-08-11 2017-11-24 N/A
3C/2200/INF

Compilation of comments on 3C/2183/DC Evaluation of Change Request to IEC 60417 and directly on IEC 60417-C00474

2016-09-09 N/A
3C/2201/DC

Validation of Change Request to IEC 60417 (C00474)

2016-09-09 2016-10-14 N/A Report of Comments
3C/2214/INF

Report of comments and votes on 3C/2201/DC Validation of Change Request to IEC 60417 (C00474)

2016-10-21 N/A
3C/2216/INF

Report from MT 60417 meeting held in Paris (France) on 2016-10-18

2016-11-04 N/A
3C/2224/DC

Validation of Change Request to IEC 60417 (C00479)

2016-12-09 2017-01-20 N/A Report of Comments
3C/2230/INF

Report of comments and votes on 3C/2224/DC Validation of Change Request to IEC 60417 (C00479)

2017-03-03 N/A
3C/2231/INF

Report from MT 60417 meeting held in Kista (Sweden) on 2017-01-31 and 2017-02-01

2017-03-03 N/A
47/2365/NP

PNW 47-2365: Future IEC 62779-4 Ed.1.0: Semiconductor devices - Semiconductor interface for human body communication- Part 4: Semiconductor interface for capsule endoscopy using human body communication

2017-01-27 2017-03-24 U Voting Result
47/2399/RVN

Result of Voting on 47/2365/NP - PNW 47-2365: Future IEC 62779-4 Ed.1.0: Semiconductor devices - Semiconductor interface for human body communication- Part 4: Semiconductor interface for capsule endoscopy using human body communication

2017-04-28 U
62A/1125A/RVDTR

Result of Voting on 62A/1093/DTR - ISO TR 80002-2, Medical device software - Part 2: Validation of software for medical device quality systems

2017-01-27 N
62A/1127A/CC

Compilation of Comments on 62A/1090/CD - IEC/TR 60601-4-4: Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements

2017-03-31 N
62A/1128A/RVDTR

Result of Voting on 62A/1097/DTR - IEC TR 80001-2-9 Ed.1: Application of risk management for IT networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities

2016-12-09 N
62A/1129A/RVDTR

Result of Voting on 62A/1099/DTR - IEC TR 60601-4-1: Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

2017-01-27 N
62A/1140/FDIS

IEC 82304-1: Health software - Part 1: General requirements for product safety

2016-09-02 2016-10-14 Y Voting Result
62A/1146A/CC

Compilation of Comments on 62A/1101/CD - IEC 62304 Ed. 2: Health software - Software life cycle processes

2017-03-31 Y
62A/1151/RVD

Report of Voting on 62A/1140/FDIS - IEC 82304-1: Health software - Part 1: General requirements for product safety

2016-10-28 Y
62A/1152/RR

Review report of IEC TR 60601-4-3 Ed.1.0: Medical electrical equipment - Part 4-3: Guidance and interpretation Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

2016-10-28 N
62A/1163/RR

Amendment 2 to IEC 60601-1 Ed.3.0 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2016-12-16 Y
62A/1165/RR

Amendment 1 to IEC 60601-1-2 Ed.4.0 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

2016-12-16 Y
62A/1167/RR

Amendment 2 to IEC 60601-1-6 Ed.3.0 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

2016-12-16 Y
62A/1169/RR

Amendment 2 to IEC 60601-1-8 Ed.2.0 – 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

2016-12-16 Y
62A/1171/RR

Amendment 2 to IEC 60601-1-10 Ed.1.0 – 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

2016-12-16 Y
62A/1173/RR

Amendment 1 to IEC 60601-1-11 Ed.2.0 – 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

2016-12-16 Y
62A/1180/RR

Review report of IEC 62366-1 Ed.1.0: Medical devices - Part 1: Application of usability engineering to medical devices

2017-02-17 Y
62A/1185/CD

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

2017-03-31 2017-05-26 Y Report of Comments
62A/1186/DTR

IEC TR 60601-4-4 ED1: Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements

2017-04-07 2017-06-02 N Voting Result
62A/1188/CD

IEC TR 60601-4-3 ED2: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

2017-04-21 2017-07-14 N Report of Comments
62A/1196/CC

Compilation of Comments on 62A/1185/CD - IEC 62304 Ed. 2: Health software - Software life cycle processes

2017-06-02 Y
62A/1197/RVDTR

Result of Voting on 62A/1186/DTR - IEC TR 60601-4-4 ED1: Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements

2017-06-23 N
62A/1200/CD

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

2017-07-14 2017-10-06 Y
62A/1202/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.

2017-07-14 2017-10-06 Y
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

2017-07-14 2017-10-06 Y
62A/1206/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

2017-07-14 2017-10-06 Y
62A/1208/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

2017-07-14 2017-10-06 Y
62A/1210/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

2017-07-14 2017-10-06 Y
62A/1212/CC

Compilation of Comments on 62A/1188/CD - IEC TR 60601-4-3 ED2: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

2017-07-21 N
62A/1217/CD

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

2017-08-04 2017-10-27 Y
62B/1050/RR

Review report of IEC 60601-2-43 Ed.2: Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

2017-03-31 Y
62B/1052/CD

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

2017-03-31 2017-06-23 Y Report of Comments
62B/1061/CC

Compilation of Comments on 62B/1052/CD - 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

2017-06-30 Y
64/2146/CD

IEC 60364-7-710: Low-voltage electrical installations - Part 7-710: Requirements for special installations or locations - Medical locations

2016-10-07 2016-12-30 Y Report of Comments
76/573/CC

Compilation of Comments on 76/552/CD - IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

2017-07-14 Y
85/593/RR

Review Report on IEC 61557-1 ED2: Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 1: General requirements

2017-06-16 Y
85/594/RR

Review report on IEC 61557-2 ED2: Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 2: Insulation resistance

2017-06-16 Y
85/595/RR

Review report on IEC 61557-3 ED2: Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 3: Loop impedance

2017-06-16 Y
85/596/RR

Review report on IEC 61557-4 Ed. 2.0:Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 4: Resistance of earth connection and equipotential bonding

2017-06-16 Y
101/528/CD

IEC 61340-6-1 ED1: Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities

2017-01-06 2017-03-03 Y Report of Comments
101/536/CC

Compilation of Comments on 101/528/CD - IEC 61340-6-1 ED1: Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities

2017-05-12 Y
106/398/DC

Document for comments on future Technical Report on contact current

2017-05-26 2017-07-07 N/A Report of Comments
109/158A/DTS

IEC TS 62993 ED1: Guidance for determination of clearances; creepage distances and requirements for solid insulation for equipment with a rated voltage above 1 000 V a.c. and 1 500 V d.c. up to 2 000 V a.c. and 3 000 V d.c.

2017-02-24 2017-04-14 N Voting Result
109/162/RVDTS

Result of Voting on 109/158A/DTS - IEC TS 62993 ED1: Guidance for determination of clearances; creepage distances and requirements for solid insulation for equipment with a rated voltage above 1 000 V a.c. and 1 500 V d.c. up to 2 000 V a.c. and 3 000 V d.c.

2017-06-09 N
121A/98/CDV

IEC 60715 Ed.2: Dimensions of low-voltage switchgear and controlgear - Standardized mounting on rails for mechanical support of switchgear, controlgear and accessories

2016-09-23 2016-12-16 Y Voting Result
124/8/DC

Review of TC 124 Strategic Business Plan (SBP)

2017-07-07 2017-08-18 N/A Report of Comments