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 (11)

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IEC 62304 am1 Ed. 1.0  

Amendement 1 - Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel
62A/925/CDV2013-07RDIS
  • RDIS
  • Text for FDIS received and registered

2015-02

CDIS
  • CDIS
  • Draft circulated as FDIS

2015-05

JWG3P. Krantz2015-09
IEC 82304-1 Ed. 1.0  

Health Software - Part 1: General requirements for product safety
62A/913/CD2011-03CDM
  • CDM
  • Committee Draft to be discussed at Meeting

2014-03

ACDV
  • ACDV
  • Draft approved for Committee Draft with Vote

2015-03

JWG7P. Krantz, P. Linders2015-09
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

1CD
  • 1CD
  • 1st Committee Draft

2009-05

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/880/NP2013-10ANW
  • ANW
  • Approved New Work

2013-10

1CD
  • 1CD
  • 1st Committee Draft

2015-03

JWG9G. S. Virk2016-10
IEC/TR 60601-4-2 Ed. 1.0  

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems
62A/971/CD2014-10CDM
  • CDM
  • Committee Draft to be discussed at Meeting

2015-01

A2CD
  • A2CD
  • Approved for 2nd Committee Draft

2015-03

MT23 
IEC/TR 60878 Ed. 3.0  

Symboles graphiques des appareils électriques en pratique médicale
62A/972/DTR2013-10APUB
  • APUB
  • Draft approved for publication

2015-02

DEC
  • DEC
  • Draft at Editing Check

2015-03

MT25M. Kratzal2015-08
IEC/TR 62366-2 Ed. 1.0  

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
62A/986/CD2011-021CD
  • 1CD
  • 1st Committee Draft

2015-01

A2CD
  • A2CD
  • Approved for 2nd Committee Draft

2015-04

JWG4E. Israelski2015-09
IEC/TR 80001-2-8 Ed. 1.0  

Application of risk management for IT-networks incorporating medical devices Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
62A/940/CD2014-03CDM
  • CDM
  • Committee Draft to be discussed at Meeting

2014-08

ACDV
  • ACDV
  • Draft approved for Committee Draft with Vote

2015-04

JWG7A. Finnegan2015-10
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/975/NP2015-02ANW
  • ANW
  • Approved New Work

2015-02

1CD
  • 1CD
  • 1st Committee Draft

2015-12

JWG7A. Finnegan2017-02
ISO/TR 80001-2-7 Ed. 1.0  

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
62A/945/DTR2013-05APUB
  • APUB
  • Draft approved for publication

2014-09

DEC
  • DEC
  • Draft at Editing Check

2015-05

JWG7S. MacMahon2015-10
ISO/TR 80002-2 Ed. 1.0  

Medical device software - Part 2: Validation of software for regulated processes
62A/754A/NP2011-08ANW
  • ANW
  • Approved New Work

2011-08

1CD
  • 1CD
  • 1st Committee Draft

2015-01

JWG3P. Krantz