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 (14)

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/1237/CD 2016-12 ACDV
  • ACDV
  • Approved for CDV

2018-03

TCDV
  • TCDV
  • Translation of CDV

2019-06

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/1298/CD 2016-12 CD
  • CD
  • Draft circulated as CD

2018-10

PCC
  • PCC
  • Preparation of CC document

2019-01

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/1204/CD 2016-12 CDM
  • CDM
  • CD to be discussed at meeting

2017-10

2018-01

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/1303/CD 2016-12 CD
  • CD
  • Draft circulated as CD

2018-12

PCC
  • PCC
  • Preparation of CC document

2019-02

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/1268/CD 2016-12 ACDV
  • ACDV
  • Approved for CDV

2018-06

TCDV
  • TCDV
  • Translation of CDV

2018-11

JWG 5 Julian Goldman 2019-12
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/1239/CD 2016-12 ACDV
  • ACDV
  • Approved for CDV

2018-03

TCDV
  • TCDV
  • Translation of CDV

2018-11

JWG 6 Hubertus Lasthaus 2019-12
IEC 62304 ED2

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

62A/1235/CDV 2016-06 CDVM
  • CDVM
  • Rejected CDV to be discussed at meeting

2018-05

2018-07

JWG 7 Patty Krantz-Zuppan 2020-01
IEC 62366-1/AMD1 ED1

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

62A/1288/CDV 2017-02 CCDV
  • CCDV
  • Draft circulated as CDV

2018-10

PRVC
  • PRVC
  • Preparation of RVC

2019-01

JWG 4 Edmond Israelski 2019-11
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 80001-1 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/1302/CD 2016-08 CD
  • CD
  • Draft circulated as CD

2018-11

PCC
  • PCC
  • Preparation of CC document

2019-02

JWG 7 Philip Raymond 2020-01
IEC 80001-5-1 ED1

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

62A/1277/NP 2018-09 ACD
  • ACD
  • Approved for CD

2018-09

CD
  • CD
  • Draft circulated as CD

2018-12

JWG 7 Georg Heidenreich 2021-10
ISO 14971 ED3

Medical devices - Application of risk management to medical devices

62A/1282/CDV 2017-04 AFDIS
  • AFDIS
  • Approved for FDIS circulation

2018-10

CFDIS
  • CFDIS
  • Draft circulated as FDIS

2019-02

JWG 1 Jos Van Vroonhoven 2019-09
ISO TR 24971 ED2

Medical devices -- Guidance on the application of ISO 14971

62A/1284/CD 2017-04 CDM
  • CDM
  • Committee Draft to be discussed at Meeting

2018-10

2019-02

JWG 1 Jos Van Vroonhoven 2019-06
ISO 81001-1 ED1

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

62A/1283/CD 2016-09 ACD
  • ACD
  • Approved for Committee Draft

2018-10

2CD
  • 2CD

2019-01

JWG 7 Michelle Jump 2020-12