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/AMD1/ISH1 ED3

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

CDISH
  • CDISH
  • Draft circulated as DISH

2020-06

PRVDISH
  • PRVDISH
  • Preparation of RVDISH

2020-07

2020-09
IEC 60601-1/AMD2 ED3

Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

62A/1389/FDIS

2016-12 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

MT 28 Charles Sidebottom P.E. 2020-08
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/1390/FDIS

2016-12 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

MT 23 Curt Sponberg 2020-08
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/1391/FDIS

2016-12 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

JWG 4 Edmond Israelski 2020-08
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/1392/FDIS

2016-12 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

JWG 2 David Osborn 2020-08
IEC 60601-1-9/AMD2 ED1

Amendment 2 - Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

62A/1393/FDIS

2019-04 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

WG 20 Charles Sidebottom P.E. 2020-08
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/1394/FDIS

2016-12 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

JWG 5 Julian Goldman 2020-08
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

62A/1395/FDIS

2016-12 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

JWG 6 Hubertus Lasthaus 2020-08
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

62A/1396/FDIS

2019-04 BPUB
  • BPUB
  • Being published

2020-06

PPUB
  • PPUB
  • Publication published

2020-08

JWG 8 Charles Sidebottom P.E. 2020-08
IEC TR 60601-4-5 ED1

IEC TR 60601-4-5: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices

62A/1402/DTR 2019-06 CDTR
  • CDTR
  • Circulation of DTR

2020-06

PRVDTR
  • PRVDTR
  • Preparation of RVDTR document

2020-08

PT 60601-4-5 Gerd Matzke 2021-04
IEC 62304 ED2

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

62A/1349/CDV 2016-06 ACDV
  • ACDV
  • Approved for CDV

2020-01

TCDV
  • TCDV
  • Translation of CDV

2020-06

JWG 7 Patty Krantz-Zuppan 2021-10
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

62A/1379/CDV 2017-03 ACDV
  • ACDV
  • Approved for CDV

2020-05

TCDV
  • TCDV
  • Translation of CDV

2020-10

WG 20 Thomas Fischer 2021-09
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

62A/1359/CDV 2016-08 AFDIS
  • AFDIS
  • Approved for FDIS

2020-05

TFDIS
  • TFDIS
  • Translation of FDIS

2020-10

JWG 7 Philip Raymond 2021-07
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

62A/1384/CD 2018-09 ACDV
  • ACDV
  • Approved for CDV

2020-05

TCDV
  • TCDV
  • Translation of CDV

2020-12

JWG 7 Georg Heidenreich 2021-07
ISO 81001-1 ED1

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

62A/1370/CDV 2016-09 AFDIS
  • AFDIS
  • Approved for FDIS circulation

2020-02

CFDIS
  • CFDIS
  • Draft circulated as FDIS

2020-09

JWG 7 Michelle Jump 2021-06
ISO TS 82304-2 ED1

Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice

62A/1343/NP 2019-11 ACD
  • ACD
  • Approved for CD

2019-11

2020-05

JWG 7 Charlie McCay 2021-06