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 (9)

Project

Reference

Document

Reference

Init.

Date

Current

Stage

Next

Stage

Working

Group

Project

Leader

Fcst. Publ.

Date

IEC TR 60513 ED3

Fundamental aspects of safety standards for medical electrical equipment

62A/983/RR 2015-01 ADTR
  • ADTR
  • Approved for DTR circulation

2015-01

TDTR
  • TDTR
  • Translation of DTR

2016-06

MT 32 J. McCarthy 2017-05
IEC TR 60601-4-1 ED1

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

62A/1099/DTR 2013-10 APUB
  • APUB
  • Approved for publication

2016-08

TPUB
  • TPUB
  • Translation of publication

2017-03

JWG 9 G. S. Virk 2017-07
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/1152/RR 2016-10 ACD
  • ACD
  • Approved for Committee Draft

2016-10

CD
  • CD
  • Draft circulated as CD

2017-05

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/1090/CD 2016-05 ADTR
  • ADTR
  • Approved for DTR circulation

2016-08

CDTR
  • CDTR
  • Circulation of DTR

2017-05

2017-07
IEC 62304 ED2

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

62A/1101/CD 2016-06 CDM
  • CDM
  • CD to be discussed at meeting

2016-09

2016-11

JWG 7 P. Krantz-Zuppan, R.de la Cruz 2019-12
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/1139/RR 2016-08 ACD
  • ACD
  • Approved for CD

2016-08

CD
  • CD
  • Draft circulated as CD

2017-06

JWG 7 P. Raymond, T. Cooper 2020-01
IEC TR 80001-2-9 ED1

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

62A/1097/DTR 2015-02 APUB
  • APUB
  • Approved for publication

2016-08

TPUB
  • TPUB
  • Translation of publication

2017-02

JWG 7 A. Finnegan 2017-07
ISO TR 80002-2 ED1

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

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

2016-08

TPUB
  • TPUB
  • Translation of publication

2017-02

JWG 3 P. Krantz 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 M. Jump and T. Cooper 2020-12