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 Project files (137)

Project

Reference

Current

Stage

Language

Frcst

Date

CLC

Document

Reference

Downloads
PNW 62A-130-8 ED1

20 graphical symbols for general use

DEL
  • DEL
  • Deleted items
EN U 62A(NL)/53/NP
PNW 62A-130-9 ED1

22 graphical symbols f0r use on medical equipment

DEL
  • DEL
  • Deleted items
EN U 62A(NL)/54/NP
PNW 62A-130-10 ED1

14 graphical symbols indicating movement for use on medical equipment

DEL
  • DEL
  • Deleted items
EN U 62A(NL)/55/NP
PNW 62A-218 ED1

Medical devices - Risk management - Application of risk management to medical devices

DEL
  • DEL
  • Deleted items
EN U 62A/218/NP
PNW 62A-287 ED1

Medical electrical equipment - x. Collateral Standard: Safety requirements for networked medical systems

DEL
  • DEL
  • Deleted items
EN U 62A/287/NP Word file 32 kB
PDF file 34 kB
PNW 62A-580 ED1

Medical devices and medical systems - Basic safety and essential performance of the patient-centric integrated clinicaenvironment (ICE) Part 1: General requirements for network controls

DEL
  • DEL
  • Deleted items
EN U 62A/580/NP PDF file 474 kB
PNW 62A-672 ED1

Medical electrical equipment - Electromagnetic compatibility and safety with regard to electromagnetic disturbances - Requirements and tests

DEL
  • DEL
  • Deleted items
EN U 62A/672/NP PDF file 1246 kB
IEC 60417/FRAG46 ED1

Amendment to IEC 417 and revision (or new edition) of IEC 60878

DEL
  • DEL
  • Deleted items
EN U 62A/244/CD
IEC 60417/FRAG47 ED1

Amendment to IEC 60417 and revision (or new edition) of IEC 60878

DEL
  • DEL
  • Deleted items
EN U 62A/246/CD
IEC 60417/FRAG48 ED1

Amendment to IEC 60417 and revision (or new edition) of IEC 60878

DEL
  • DEL
  • Deleted items
EN U 62A/245/CD
IEC TR 60513 ED3

Fundamental aspects of safety standards for medical electrical equipment

DEL
  • DEL
  • Deleted items
EN 2017-05 N 62A/983/RR PDF file 94 kB
IEC TR 60513/FRAG1 ED3

Standardization of medical electrical equipment safety

MERGED
  • MERGED
  • Fragment merged
EN 2011-01 N 62A/652/CD PDF file 153 kB
IEC TR 60513:1994 ED2

Fundamental aspects of safety standards for medical electrical equipment

PPUB
  • PPUB
  • Publication issued
EN-FR U Webstore
IEC 60601-1:2005 ED3

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

PPUB
  • PPUB
  • Publication issued
EN-FR Y Webstore
IEC 60601-1/FRAG1 ED3

Third edition of IEC 601-1 - Additional Clauses to Clauses 2, 37, 41.5 and 43

MERGED
  • MERGED
  • Fragment merged
EN U 62A(DE)/77/NP
IEC 60601-1/FRAG2 ED3

Exception to the requirement regarding failure of components - Sub-clause 52.5.9 -Failure of components- of IEC 601-1

DEL
  • DEL
  • Deleted items
EN U 62A(SE)/48/NP
IEC 60601-1/FRAG3 ED3

Amendment to IEC 601-1 to clarify Clause 19 regarding leakage currents

MERGED
  • MERGED
  • Fragment merged
EN U
IEC 60601-1/FRAG11 ED3

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

MERGED
  • MERGED
  • Fragment merged
EN Y 62A/389/CDV PDF file 3783 kB
IEC 60601-1:2005/ISH1:2008 ED3

Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
EN-FR 2008-05 U Webstore
IEC 60601-1:2005/ISH2:2009 ED3

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2009-02 U Webstore
IEC 60601-1:2005/ISH3:2013 ED3

Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
EN-FR 2013-05 U Webstore
IEC 60601-1:2005/COR1:2006 ED3

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

PPUB
  • PPUB
  • Publication issued
EN-FR U Webstore
IEC 60601-1:2005/COR2:2007 ED3

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

PPUB
  • PPUB
  • Publication issued
EN-FR U Webstore
IEC 60601-1:2005/AMD1:2012 ED3

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2012-08 Y Webstore
IEC 60601-1:2005/AMD1:2012/COR1:2014 ED3

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

PPUB
  • PPUB
  • Publication issued
EN-FR U Webstore
IEC 60601-1/AMD2 ED3

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

ACD
  • ACD
  • Approved for CD
EN 2019-12 Y 62A/1163/RR PDF file 33 kB
IEC 60601-1:1988 ED2

Medical electrical equipment - Part 1: General requirements for safety

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60601-1:1988/AMD1:1991 ED2

Amendment 1 - Medical electrical equipment - Part 1: General requirements for safety

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60601-1:1988/AMD2:1995 ED2

Amendment 2 - Medical electrical equipment - Part 1: General requirements for safety

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y
IEC 60601-1:1977 ED1

Medical electrical equipment. Part 1: General requirements.

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60601-1-1:2000 ED2

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

WPUB
  • WPUB
  • Publication Withdrawn
EN-FR 1999-10 Y 62A/878/RR PDF file 99 kB
IEC 60601-1-1:1992 ED1

Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60601-1-1:1992/AMD1:1995 ED1

Amendment 1 - Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y 62A(SEC.)/163/CDV
IEC 60601-1-2:2014 ED4

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

PPUB
  • PPUB
  • Publication issued
EN-FR 2014-03 Y Webstore
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.

ACD
  • ACD
  • Approved for CD
EN 2019-12 Y 62A/1165/RR PDF file 109 kB
IEC 60601-1-2:2007 ED3

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2007-03 Y 62A/560/FDIS

IEC 60601-1-2:2007/ISH1:2010 ED3

Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2010-03 U
IEC 60601-1-2:2001+AMD1:2004 CSV ED2.1

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60601-1-2/FRAGF+AMD1:2004 CSV ED2.1

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

MERGED
  • MERGED
  • Publication merged with EN version
EN-FR U
IEC 60601-1-2:2001 ED2

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y 62A/336/FDIS
IEC 60601-1-2/FRAGf ED2

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

MERGED
  • MERGED
  • Fragment merged
EN-FR U
IEC 60601-1-2:2001/AMD1:2004 ED2

Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y 62A/462/FDIS
IEC 60601-1-2/AMD1/FRAGf ED2

Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

MERGED
  • MERGED
  • Fragment merged
EN-FR U
IEC 60601-1-2:1993 ED1

Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U 62A(SEC.)/109/CDV
IEC 60601-1-6:2010 ED3

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

PPUB
  • PPUB
  • Publication issued
EN-FR 2010-02 Y Webstore
IEC 60601-1-6:2010/AMD1:2013 ED3

Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

PPUB
  • PPUB
  • Publication issued
EN-FR 2013-10 Y Webstore
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

ACD
  • ACD
  • Approved for CD
EN 2019-12 Y 62A/1167/RR PDF file 106 kB
IEC 60601-1-6:2006 ED2

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2006-12 Y 62A/550/FDIS

IEC 60601-1-6:2004 ED1

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y 62A/452/FDIS

IEC 60601-1-8:2006 ED2

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2007-03 Y Webstore
IEC 60601-1-8:2006/AMD1:2012 ED2

Amendment 1 - 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

PPUB
  • PPUB
  • Publication issued
EN-FR 2012-11 Y Webstore
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

ACD
  • ACD
  • Approved for CD
EN 2019-12 Y 62A/1169/RR PDF file 108 kB
IEC 60601-1-8:2003 ED1

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y 62A/424/FDIS
IEC 60601-1-8/FRAGf ED1

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

MERGED
  • MERGED
  • Fragment merged
EN-FR U
IEC 60601-1-8:2003/AMD1:2006 ED1

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2006-03 Y 62A/513/FDIS

IEC 60601-1-9:2007 ED1

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

PPUB
  • PPUB
  • Publication issued
EN-FR 2007-08 Y Webstore
IEC 60601-1-9:2007/AMD1:2013 ED1

Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

PPUB
  • PPUB
  • Publication issued
EN-FR 2013-06 Y Webstore
IEC 60601-1-10:2007 ED1

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2007-12 Y Webstore
IEC 60601-1-10:2007/AMD1:2013 ED1

Amendment 1 - 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

PPUB
  • PPUB
  • Publication issued
EN-FR 2013-10 Y Webstore
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

ACD
  • ACD
  • Approved for CD
EN 2019-12 Y 62A/1171/RR PDF file 107 kB
IEC 60601-1-11:2015 ED2

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2015-01 Y Webstore
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

ACD
  • ACD
  • Approved for CD
EN 2019-12 Y 62A/1173/RR PDF file 107 kB
IEC 60601-1-11:2010 ED1

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

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2010-04 Y 62A/693/FDIS

IEC 60601-1-11:2010/COR1:2011 ED1

Corrigendum 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

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60601-1-12:2014 ED1

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2014-07 Y Webstore
IEC TR 60601-4-1:2017 ED1

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

PPUB
  • PPUB
  • Publication issued
EN N Webstore
IEC TR 60601-4-2:2016 ED1

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

PPUB
  • PPUB
  • Publication issued
EN 2016-06 N Webstore
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

CD
  • CD
  • Committee Draft
EN 2018-11 N 62A/1188/CD
PDF file 1452 kB
IEC TR 60601-4-3:2015 ED1

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

PPUB
  • PPUB
  • Publication issued
EN 2015-04 N Webstore
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

CDTR
  • CDTR
  • Circulation of DTR
EN 2018-02 N 62A/1186/DTR PDF file 649 kB
IEC 60788:1984 ED1

Medical radiology - Terminology

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC TR 60878:2015 ED3

Graphical symbols for electrical equipment in medical practice

PPUB
  • PPUB
  • Publication issued
EN-FR 2015-09 N Webstore
IEC TR 60878:2003 ED2

Graphical symbols for electrical equipment in medical practice

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2004-05 N 62A/416/DTR PDF file 2488 kB
IEC 60878/FRAG6 ED2

Elements on graphical symbols in medical radiology

DEL
  • DEL
  • Deleted items
EN U
IEC 60878/FRAG9 ED2

Specific symbols for NMR - Specific symbols for ultrasonic diagnostic equipment - Specific symbols for cardiac pacemaker and for monitoring equipment

DEL
  • DEL
  • Deleted items
EN-FR U
IEC 60878/AMD1/FRAG1 ED2

8 graphical symbols for data processing on medical equipment

DEL
  • DEL
  • Deleted items
EN U 62A/213/NP
IEC 60878/AMD1/FRAG2 ED2

12 graphical symbols for radiologic equipment

DEL
  • DEL
  • Deleted items
EN U 62A/214/NP
IEC 60878/AMD1/FRAG3 ED2

14 graphical symbols for medical monitoring equipment

DEL
  • DEL
  • Deleted items
EN U 62A/215/NP
IEC TR 60878:1988 ED1

Graphical symbols for electrical equipment in medical practice

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC 60878/AMD1/FRAG1 ED1

Graphical symbols for use on medical equipment - Part 2: Nuclear medicine

MERGED
  • MERGED
  • Fragment merged
EN-FR Y 62A/171/CDV
IEC 60878/AMD1/FRAG2 ED1

Graphical symbols for use on medical equipment - Part 3: Radiological equipment

MERGED
  • MERGED
  • Fragment merged
EN-FR Y 62A/172/CDV
IEC TR 60878/AMD1/FRAG2 ED1

VOTING FORM to Graphical symbol: Multi-pulse (60417-IEC-5842 Pr)

MERGED
  • MERGED
  • Fragment merged
EN U 62A/299/CDV
IEC TR 60878/AMD1/FRAG3 ED1

VOTING FORM to Graphical symbol: Target position (60417-IEC-5843 Pr)

MERGED
  • MERGED
  • Fragment merged
EN U 62A/300/CDV
IEC 60878/AMD1/FRAG3 ED1

Graphical symbols for use on medical equipment - Part 1: General

MERGED
  • MERGED
  • Fragment merged
EN-FR Y 62A/170/CDV
IEC TR 60878/AMD1/FRAG4 ED1

VOTING FORM to Graphical symbol: Body temperature (60417-IEC-5844 Pr)

MERGED
  • MERGED
  • Fragment merged
EN U 62A/301/CDV
IEC TR 60878/AMD1/FRAG5 ED1

VOTING FORM to Graphical symbol: Inner diameter (60417-IEC-5845 Pr)

MERGED
  • MERGED
  • Fragment merged
EN U 62A/302/CDV
IEC TR 60878/AMD1/FRAG6 ED1

VOTING FORM to Graphical symbol: Outer diameter (60417-IEC-5846 Pr)

MERGED
  • MERGED
  • Fragment merged
EN U 62A/303/CDV
IEC TR 60878/AMD1/FRAG7 ED1

VOTING FORM to Graphical symbol: Trend (60417-IEC-5847 Pr)

MERGED
  • MERGED
  • Fragment merged
EN U 62A/304/CDV
IEC TR 60930:2008 ED2

Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

PPUB
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  • Publication issued
EN 2008-09 N Webstore
IEC TR 60930/FRAG1 ED2

Systematic review of IEC 930 (1988)

CAN
  • CAN
  • Draft Cancelled
EN-FR U
IEC TR 60930:1988 ED1

Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U
IEC TR 61258:2008 ED2

Guidelines for the development and use of medical electrical equipment educational materials

PPUB
  • PPUB
  • Publication issued
EN 2008-09 N Webstore
IEC TR 61258:1994 ED1

Guidelines for the development and use of medical electrical equipment educational materials

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR U 62A(SEC.)/102/CD
IEC 61961 ED1

Safe technology management of electrical equipment for medical use within health care

DEL
  • DEL
  • Deleted items
EN U 62A/198/NP
IEC TR 62296:2009 ED2

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

PPUB
  • PPUB
  • Publication issued
EN 2009-01 N Webstore
IEC TR 62296:2003 ED1

Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements

DELPUB
  • DELPUB
  • Publication Deleted
EN 2003-10 N 62A/398/DTR PDF file 392 kB
IEC 62304 ED2

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

PCC
  • PCC
  • Preparation of CC
EN 2019-12 Y 62A/1185/CD
PDF file 1161 kB
IEC 62304/FRAG1 ED2

Medical device software - Software life cycle processes

MERGED
  • MERGED
  • Fragment merged
EN 2014-01 Y 62A/838/CD PDF file 1374 kB
IEC 62304:2006 ED1

Medical device software - Software life cycle processes

PPUB
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EN-FR 2006-06 Y Webstore
IEC 62304:2006/AMD1:2015 ED1

Amendment 1 - Medical device software - Software life cycle processes

PPUB
  • PPUB
  • Publication issued
EN 2015-06 Y Webstore
IEC TR 62348:2012 ED2

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

PPUB
  • PPUB
  • Publication issued
EN 2013-01 N Webstore
IEC TR 62348:2006 ED1

Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended FREE DOWNLOAD

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2006-07 N 62A/506/DTR PDF file 1648 kB
PDF file 1435 kB
IEC 62353:2014 ED2

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

PPUB
  • PPUB
  • Publication issued
EN-FR 2014-09 Y Webstore
IEC 62353:2007 ED1

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2007-05 Y 62A/564/FDIS

IEC TR 62354:2014 ED3

General testing procedures for medical electrical equipment

PPUB
  • PPUB
  • Publication issued
EN 2014-10 N Webstore
IEC TR 62354:2009 ED2

General testing procedures for medical electrical equipment

DELPUB
  • DELPUB
  • Publication Deleted
EN 2009-10 N 62A/647/DTR PDF file 1246 kB
IEC TR 62354:2005 ED1

General testing procedures for medical electrical equipment

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2006-02 N 62A/480/DTR PDF file 2015 kB
IEC 62366:2007 ED1

Medical devices - Application of usability engineering to medical devices

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2007-10 Y 62A/574/FDIS

IEC 62366:2007/AMD1:2014 ED1

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

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR 2013-11 Y 62A/889/FDIS

IEC 62366-1:2015 ED1

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

PPUB
  • PPUB
  • Publication issued
EN-FR 2015-03 Y Webstore
IEC 62366-1:2015/COR1:2016 ED1

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

PPUB
  • PPUB
  • Publication issued
EN-FR U Webstore
IEC 62366-1/AMD1 ED1

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

ACDV
  • ACDV
  • Approved for CDV
EN 2019-06 Y 62A/1180/RR PDF file 93 kB
IEC TR 62366-2:2016 ED1

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

PPUB
  • PPUB
  • Publication issued
EN 2016-05 N Webstore
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

ACD
  • ACD
  • Approved for CD
EN 2020-04 Y 62A/1177/NP PDF file 216 kB
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

ACD
  • ACD
  • Approved for CD
EN 2020-01 Y 62A/1139/RR PDF file 130 kB
IEC 80001-1:2010 ED1

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

PPUB
  • PPUB
  • Publication issued
EN-FR 2010-10 Y Webstore
IEC TR 80001-2-1:2012 ED1

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

PPUB
  • PPUB
  • Publication issued
EN 2012-07 N Webstore
IEC TR 80001-2-2:2012 ED1

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

PPUB
  • PPUB
  • Publication issued
EN 2012-07 N Webstore
IEC TR 80001-2-3:2012 ED1

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

PPUB
  • PPUB
  • Publication issued
EN 2012-07 N Webstore
IEC TR 80001-2-4:2012 ED1

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

PPUB
  • PPUB
  • Publication issued
EN 2012-12 U Webstore
IEC TR 80001-2-5:2014 ED1

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

PPUB
  • PPUB
  • Publication issued
EN 2014-12 N Webstore
IEC TR 80001-2-8:2016 ED1

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 TR 80001-2-2

PPUB
  • PPUB
  • Publication issued
EN 2016-06 N Webstore
IEC TR 80001-2-9:2017 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

PPUB
  • PPUB
  • Publication issued
EN 2017-02 N Webstore
IEC TR 80002-1:2009 ED1

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

PPUB
  • PPUB
  • Publication issued
EN 2009-10 N Webstore
IEC TR 80002-3:2014 ED1

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

PPUB
  • PPUB
  • Publication issued
EN 2014-06 N Webstore
IEC 82304-1:2016 ED1

Health software - Part 1: General requirements for product safety

PPUB
  • PPUB
  • Publication issued
EN-FR 2016-11 Y Webstore
ISO 14971 ED3

Medical devices - Application of risk management to medical devices

ACD
  • ACD
  • Approved for CD
EN 2019-06 N 62A/1190/RR PDF file 104 kB
ISO 14971:2007 ED2

Medical devices - Application of risk management to medical devices

PPUB
  • PPUB
  • Publication issued
EN-FR 2007-04 N Webstore
ISO 14971:2000 ED1

Medical devices - Risk management - Application of risk management to medical devices

DELPUB
  • DELPUB
  • Publication Deleted
EN-FR Y 62A/316/FDIS

ISO 14971:2000/AMD1:2003 ED1

Amendment 1 - Medical devices - Application of risk management to medical devices

DELPUB
  • DELPUB
  • Publication Deleted
EN N 62A/412/FDIS
ISO TR 17791:2013 ED1

Health informatics -- Guidance on standards for enabling safety in health software

PPUB
  • PPUB
  • Publication issued
EN 2014-02 N Webstore
ISO TR 24971 ED2

Medical devices -- Guidance on the application of ISO 14971

ACD
  • ACD
  • Approved for Committee Draft
EN 2019-06 N 62A/1189/RR PDF file 103 kB
ISO TR 24971:2013 ED1

Medical devices -- Guidance on the application of ISO 14971

PPUB
  • PPUB
  • Publication issued
EN 2013-06 N Webstore
ISO TR 80001-2-6:2014 ED1

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

PPUB
  • PPUB
  • Publication issued
EN 2014-03 N Webstore
ISO TR 80001-2-7:2015 ED1

Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

PPUB
  • PPUB
  • Publication issued
EN 2015-03 N Webstore
ISO TR 80002-2 ED1

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

APUB
  • APUB
  • Approved for publication
EN 2017-07 N 62A/1093/DTR PDF file 883 kB
ISO 81001-1 ED1

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

ACD
  • ACD
  • Approved for Committee Draft
EN 2020-12 U 62A/1096/NP PDF file 1313 kB