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

SC 62A

Common aspects of electrical equipment used in medical practice

 
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SC 62A Work programme (16)

Project

Reference

Document

Reference

Init.

Date

Current

Stage

Next

Stage

Working

Group

Project

Leader

Fcst. Publ.

Date

IEC 60601-1/AMD2 ED3

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

62A/1163/RR 2016-12 ACD
  • ACD
  • Approved for CD

2016-12

CD
  • CD
  • Draft circulated as CD

2017-07

MT 28 Charles Sidebottom P.E. 2019-12
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.

62A/1165/RR 2016-12 ACD
  • ACD
  • Approved for CD

2016-12

CD
  • CD
  • Draft circulated as CD

2017-07

MT 23 Curt Sponberg 2019-12
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

62A/1167/RR 2016-12 ACD
  • ACD
  • Approved for CD

2016-12

CD
  • CD
  • Draft circulated as CD

2017-07

JWG 4 Edmond Israelski 2019-12
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

62A/1169/RR 2016-12 ACD
  • ACD
  • Approved for CD

2016-12

CD
  • CD
  • Draft circulated as CD

2017-07

JWG 2 David Osborn 2019-12
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

62A/1171/RR 2016-12 ACD
  • ACD
  • Approved for CD

2016-12

CD
  • CD
  • Draft circulated as CD

2017-07

JWG 5 Julian Goldman 2019-12
IEC 60601-1-11/AMD1ED2

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

62A/1173/RR 2016-12 ACD
  • ACD
  • Approved for CD

2016-12

CD
  • CD
  • Draft circulated as CD

2017-06

JWG 6 Hubertus Lasthaus 2019-12
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

62A/1188/CD 2016-10 CD
  • CD
  • Committee Draft

2017-04

PCC
  • PCC
  • Preparation of CC document

2017-07

WG 14 M. Schneeberg 2018-11
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

62A/1186/DTR 2016-05 CDTR
  • CDTR
  • Circulation of DTR

2017-04

PRVDTR
  • PRVDTR
  • Preparation of RVDTR document

2017-06

2018-02
IEC 62304ED2

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

62A/1185/CD 2016-06 PCC
  • PCC
  • Preparation of CC

2017-05

2017-06

JWG 7 Patty Krantz-Zuppan 2019-12
IEC 62366-1/AMD1 ED1

Medical devices - Part 1: Application of usability engineering to medical devices

62A/1180/RR 2017-02 ACDV
  • ACDV
  • Approved for CDV

2017-02

TCDV
  • TCDV
  • Translation of CDV

2017-07

JWG 4 Edmond Israelski 2019-06
IEC 63120 ED1

Environmental conscious design of medical electrical equipment – Particular requirements for refurbishment of medical electrical equipment and systems, for re-use of parts, for a management of critical or hazardous substances contained in medical electrical equipment and systems and for a closed loop Business-to-Business take back system

62A/1177/NP 2017-03 ACD
  • ACD
  • Approved for CD

2017-03

CD
  • CD
  • Draft circulated as CD

2018-02

WG 20 Thomas Fischer 2020-04
IEC 80001-1ED2

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

62A/1139/RR 2016-08 ACD
  • ACD
  • Approved for CD

2016-08

CD
  • CD
  • Draft circulated as CD

2017-06

JWG 7 Philip Raymond 2020-01
ISO 14971 ED3

Medical devices - Application of risk management to medical devices

62A/1190/RR 2017-04 ACD
  • ACD
  • Approved for CD

2017-04

CD
  • CD
  • Draft circulated as CD

2017-11

JWG 1 Jos Van Vroonhoven 2019-06
ISO TR 24971 ED2

Medical devices -- Guidance on the application of ISO 14971

62A/1189/RR 2017-04 ACD
  • ACD
  • Approved for Committee Draft

2017-04

CD
  • CD
  • Draft circulated as CD

2017-11

JWG 1 Jos Van Vroonhoven 2019-06
ISO TR 80002-2ED1

Medical device software - Part 2: Validation of software for medical device quality systems

62A/1093/DTR 2011-08 APUB
  • APUB
  • Approved for publication

2017-03

2017-04

JWG 3 Patty Krantz-Zuppan 2017-07
ISO 81001-1 ED1

Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

62A/1096/NP 2016-09 ACD
  • ACD
  • Approved for Committee Draft

2016-09

CD
  • CD
  • Draft circulated as CD

2017-10

JWG 7 Michelle Jump 2020-12