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

SC 62A

Aspects généraux des équipements électriques utilisés en pratique médicale

 
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SC 62A Programme de Travail (9)

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IEC 62304 Ed. 2.0  

Review report of IEC 62304 Ed. 2: Health software - Software life cycle processes
62A/1101/CD2016-06CDM
  • CDM
  • Committee Draft to be discussed at Meeting

2016-09

A2CD
  • A2CD
  • Approved for 2nd Committee Draft

2016-11

JWG7P. Krantz-Zuppan2019-12
IEC 80001-1 Ed. 2.0  

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/RR2016-08AMW
  • AMW
  • Approved Maintenance Work

2016-08

1CD
  • 1CD
  • 1st Committee Draft

2017-06

JWG 7P. Raymond, T. Cooper2020-01
IEC 82304-1 Ed. 1.0  

Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits
62A/1140/FDIS2011-03CDIS
  • CDIS
  • Draft circulated as FDIS

2016-09

APUB
  • APUB
  • Draft approved for publication

2016-11

JWG7P. Krantz, P. Linders2016-12
IEC/TR 60513 Ed. 3.0  

Fundamental aspects of safety standards for medical electrical equipment
62A/983/RR2015-01AMW
  • AMW
  • Approved Maintenance Work

2015-01

CDTR
  • CDTR
  • Circulated Draft Technical Report

2016-06

MT32J. McCarthy2017-01
IEC/TR 60601-4-1 Ed. 1.0  

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
62A/1099/DTR2013-10APUB
  • APUB
  • Draft approved for publication

2016-08

DEC
  • DEC
  • Draft at Editing Check

2017-03

JWG9G. S. Virk2017-07
IEC/TR 60601-4-4 Ed. 1.0  

Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements
62A/1090/CD2016-05ACDV
  • ACDV
  • Draft approved for Committee Draft with Vote

2016-08

CDTR
  • CDTR
  • Circulated Draft Technical Report

2017-05

2017-07
IEC/TR 80001-2-9 Ed. 1.0  

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/DTR2015-02APUB
  • APUB
  • Draft approved for publication

2016-08

DEC
  • DEC
  • Draft at Editing Check

2017-02

JWG7A. Finnegan2017-07
ISO 81001-1 Ed. 1.0  

Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms
62A/1096/NP2016-09ANW
  • ANW
  • Approved New Work

2016-09

1CD
  • 1CD
  • 1st Committee Draft

2017-10

JWG7M. Jump and T. Cooper2020-12
ISO/TR 80002-2 Ed. 1.0  

Medical device software - Part 2: Validation of software for medical device quality systems
62A/1093/DTR2011-08APUB
  • APUB
  • Draft approved for publication

2016-08

DEC
  • DEC
  • Draft at Editing Check

2017-02

JWG3P. Krantz2017-07