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 (18)

Project

Reference

Document

Reference

Init.

Date

Current

Stage

Next

Stage

Working

Group

Project

Leader

Fcst. Publ.

Date

PNW TS 62A-1343

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

62A/1343/NP PRVN
  • PRVN
  • Preparation of RVN document

2019-09

2019-10

JWG 7 Charlie McCay 2021-06
IEC 60601-1/AMD2 ED3

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

62A/1320/CDV 2016-12 AFDIS
  • AFDIS
  • Approved for FDIS

2019-08

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

MT 28 Charles Sidebottom P.E. 2020-10
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/1321/CDV 2016-12 AFDIS
  • AFDIS
  • Approved for FDIS

2019-08

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

MT 23 Curt Sponberg 2020-10
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/1324/CDV 2016-12 AFDIS
  • AFDIS
  • Approved for FDIS

2019-09

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

JWG 4 Edmond Israelski 2020-10
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/1325/CDV 2016-12 AFDIS
  • AFDIS
  • Approved for FDIS

2019-09

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

JWG 2 David Osborn 2020-10
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/1326/CDV 2019-04 AFDIS
  • AFDIS
  • Approved for FDIS

2019-09

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

WG 20 Charles Sidebottom P.E. 2020-10
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/1327/CDV 2016-12 AFDIS
  • AFDIS
  • Approved for FDIS

2019-09

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

JWG 5 Julian Goldman 2020-10
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/1328/CDV 2016-12 AFDIS
  • AFDIS
  • Approved for FDIS

2019-09

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

JWG 6 Hubertus Lasthaus 2020-10
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/1329/CDV 2019-04 AFDIS
  • AFDIS
  • Approved for FDIS

2019-09

TFDIS
  • TFDIS
  • Translation of FDIS

2020-01

JWG 8 Charles Sidebottom P.E. 2020-10
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/1341/CD 2019-06 PCC
  • PCC
  • Preparation of CC document

2019-09

2019-10

2020-09
IEC 62304 ED2

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

62A/1349/CDV 2016-06 CCDV
  • CCDV
  • Draft circulated as CDV

2019-10

PRVC
  • PRVC
  • Preparation of RVC

2019-12

JWG 7 Patty Krantz-Zuppan 2020-11
IEC 62366-1/AMD1 ED1

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

62A/1288/CDV 2017-02 RFDIS
  • RFDIS
  • FDIS received and registered

2019-09

CFDIS
  • CFDIS
  • Draft circulated as FDIS

2019-12

JWG 4 Edmond Israelski 2020-03
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/1332/CD 2017-03 PCC
  • PCC
  • Preparation of CC

2019-08

2019-09

WG 20 Thomas Fischer 2020-12
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 CCDV
  • CCDV
  • Draft circulated as CDV

2019-11

PRVC
  • PRVC
  • Preparation of RVC

2020-01

JWG 7 Philip Raymond 2020-12
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/1360/CD 2018-09 PCC
  • PCC
  • Preparation of CC

2019-11

2019-12

JWG 7 Georg Heidenreich 2021-07
ISO 14971 ED3

Medical devices - Application of risk management to medical devices

62A/1330/FDIS

2017-04 APUB
  • APUB
  • Approved for publication

2019-07

2019-07

JWG 1 Jos Van Vroonhoven 2020-05
ISO TR 24971 ED2

Medical devices -- Guidance on the application of ISO 14971

62A/1331/DTR

2017-04 APUB
  • APUB
  • Approved for publication

2019-07

BPUB
  • BPUB
  • Publication being printed

2019-12

JWG 1 Jos Van Vroonhoven 2020-04
ISO 81001-1 ED1

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

62A/1370/CDV 2016-09 CCDV
  • CCDV
  • Circulation of CDV

2019-11

PRVC
  • PRVC
  • Preparation of RVC

2020-02

JWG 7 Michelle Jump 2020-12