SC 62A |
Common aspects of electrical equipment used in medical practice |

Project Reference |
Current Stage |
Language
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Frcst Date |
CLC
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Document Reference |
Downloads
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PNW 62A-130-8 ED1
20 graphical symbols for general use
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DEL
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EN | U | 62A(NL)/53/NP | ||
PNW 62A-130-9 ED1
22 graphical symbols f0r use on medical equipment
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DEL
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EN | U | 62A(NL)/54/NP | ||
PNW 62A-130-10 ED1
14 graphical symbols indicating movement for use on medical equipment
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DEL
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EN | U | 62A(NL)/55/NP | ||
PNW 62A-218 ED1
Medical devices - Risk management - Application of risk
management to medical devices
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DEL
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EN | U | 62A/218/NP | ||
PNW 62A-287 ED1
Medical electrical equipment - x. Collateral Standard: Safety requirements for networked medical systems
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DEL
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EN | U | 62A/287/NP |
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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
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DEL
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EN | U | 62A/580/NP |
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PNW 62A-672 ED1
Medical electrical equipment - Electromagnetic compatibility and safety with regard to electromagnetic disturbances - Requirements and tests
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DEL
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EN | U | 62A/672/NP |
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PNW TS 62A-1429 ED1
Safe, effective, and secure health software and health IT systems - Assurance cases
Application guidance — Guidance for the use of assurance cases – safety & security |
PNW
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EN | 2023-02 | U | 62A/1429/NP |
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IEC 60417/FRAG46 ED1
Amendment to IEC 417 and revision (or new edition) of IEC 60878
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DEL
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EN | U | 62A/244/CD | ||
IEC 60417/FRAG47 ED1
Amendment to IEC 60417 and revision (or new edition) of IEC 60878
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DEL
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EN | U | 62A/246/CD | ||
IEC 60417/FRAG48 ED1
Amendment to IEC 60417 and revision (or new edition) of IEC 60878
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DEL
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EN | U | 62A/245/CD | ||
IEC TR 60513 ED3
Fundamental aspects of safety standards for medical electrical equipment
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DEL
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EN | 2017-05 | N | 62A/983/RR |
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IEC TR 60513/FRAG1 ED3
Standardization of medical electrical equipment safety
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MERGED
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EN | 2011-01 | N | 62A/671/CC |
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IEC TR 60513:1994 ED2
Fundamental aspects of safety standards for medical electrical equipment
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PPUB
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EN-FR | U | Webstore | ||
IEC 60601-1:2005 ED3
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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PPUB
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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
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MERGED
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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
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DEL
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EN | U | 62A(SE)/48/NP | ||
IEC 60601-1/FRAG3 ED3
Amendment to IEC 601-1 to clarify Clause 19 regarding leakage
currents
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MERGED
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EN | U | |||
IEC 60601-1/FRAG11 ED3
Medical electrical equipment - Part 1: General requirements for safety and essential performance
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MERGED
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EN | Y | 62A/389/CDV |
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IEC 60601-1:2005/ISH1:2008 ED3
Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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PPUB
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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
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PPUB
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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
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PPUB
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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
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PPUB
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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
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PPUB
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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
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PPUB
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EN-FR | 2012-08 | Y | Webstore | |
IEC 60601-1/AMD1/ISH1 ED3
Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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BPUB
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EN | 2021-01 | E | ||
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
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PPUB
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EN-FR | U | Webstore | ||
IEC 60601-1:2005/AMD2:2020 ED3
Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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PPUB
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EN | 2020-09 | Y | Webstore | |
IEC 60601-1:1988 ED2
Medical electrical equipment - Part 1: General requirements for safety
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DELPUB
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EN-FR | U | |||
IEC 60601-1:1988/AMD1:1991 ED2
Amendment 1 - Medical electrical equipment - Part 1: General requirements for safety
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DELPUB
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EN-FR | U | |||
IEC 60601-1:1988/AMD2:1995 ED2
Amendment 2 - Medical electrical equipment - Part 1: General requirements for safety
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DELPUB
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EN-FR | Y | 62A(SEC.)/114/CDV | ||
IEC 60601-1:1977 ED1
Medical electrical equipment. Part 1: General requirements.
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DELPUB
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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
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WPUB
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EN-FR | 1999-10 | Y | 62A/878/RR |
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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
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DELPUB
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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
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DELPUB
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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
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PPUB
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EN-FR | 2014-03 | Y | Webstore | |
IEC 60601-1-2:2014/AMD1:2020 ED4
Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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PPUB
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EN | 2020-09 | Y | Webstore | |
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
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DELPUB
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EN-FR | 2007-03 | Y | 62A/560/FDIS |
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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
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DELPUB
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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
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DELPUB
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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
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MERGED
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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
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DELPUB
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EN-FR | Y | 62A/336/FDIS |
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IEC 60601-1-2/FRAGf ED2
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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MERGED
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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
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DELPUB
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EN-FR | Y | 62A/462/FDIS |
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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
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MERGED
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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
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DELPUB
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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
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PPUB
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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
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PPUB
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EN-FR | 2013-10 | Y | Webstore | |
IEC 60601-1-6:2010/AMD2:2020 ED3
Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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PPUB
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EN-FR | 2020-08 | Y | Webstore | |
IEC 60601-1-6:2006 ED2
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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DELPUB
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EN-FR | 2006-12 | Y | 62A/550/FDIS |
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IEC 60601-1-6:2004 ED1
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability
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DELPUB
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EN-FR | Y | 62A/452/FDIS |
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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
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PPUB
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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
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PPUB
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EN-FR | 2012-11 | Y | Webstore | |
IEC 60601-1-8:2006/AMD2:2020 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
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PPUB
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EN | 2020-08 | Y | Webstore | |
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
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DELPUB
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EN-FR | Y | 62A/424/FDIS |
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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
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MERGED
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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
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DELPUB
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EN-FR | 2006-03 | Y | 62A/513/FDIS |
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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
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PPUB
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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
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PPUB
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EN-FR | 2013-06 | Y | Webstore | |
IEC 60601-1-9:2007/AMD2:2020 ED1
Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
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PPUB
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EN-FR | 2020-08 | 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
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PPUB
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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
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PPUB
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EN-FR | 2013-10 | Y | Webstore | |
IEC 60601-1-10:2007/AMD2:2020 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
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PPUB
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EN-FR | 2020-08 | Y | Webstore | |
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
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PPUB
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EN-FR | 2015-01 | Y | Webstore | |
IEC 60601-1-11:2015/AMD1:2020 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
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PPUB
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EN-FR | 2020-08 | Y | Webstore | |
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
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DELPUB
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EN-FR | 2010-04 | Y | 62A/693/FDIS |
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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
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DELPUB
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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
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PPUB
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EN-FR | 2014-07 | Y | Webstore | |
IEC 60601-1-12:2014/AMD1:2020 ED1
Amendment 1 - 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
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PPUB
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EN-FR | 2020-08 | 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
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PPUB
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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
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PPUB
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EN | 2016-06 | N | Webstore | |
IEC TR 60601-4-3:2018 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
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PPUB
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EN | 2019-01 | N | Webstore | |
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
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DELPUB
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EN | 2015-04 | N | 62A/951/DTR |
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IEC TR 60601-4-4:2017 ED1
Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
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PPUB
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EN | 2017-07 | N | Webstore | |
IEC TR 60601-4-5:2021 ED1
Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications
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PPUB
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EN | 2021-01 | N | Webstore | |
IEC 60788:1984 ED1
Medical radiology - Terminology
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DELPUB
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EN-FR | U | |||
IEC TR 60878:2015 ED3
Graphical symbols for electrical equipment in medical practice
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PPUB
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EN-FR | 2015-09 | N | Webstore | |
IEC TR 60878:2003 ED2
Graphical symbols for electrical equipment in medical practice
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DELPUB
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EN-FR | 2004-05 | N | 62A/416/DTR |
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IEC 60878/FRAG6 ED2
Elements on graphical symbols in medical radiology
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DEL
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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
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DEL
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EN-FR | U | |||
IEC 60878/AMD1/FRAG1 ED2
8 graphical symbols for data processing on medical equipment
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DEL
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EN | U | 62A/213/NP | ||
IEC 60878/AMD1/FRAG2 ED2
12 graphical symbols for radiologic equipment
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DEL
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EN | U | 62A/214/NP | ||
IEC 60878/AMD1/FRAG3 ED2
14 graphical symbols for medical monitoring equipment
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DEL
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EN | U | 62A/215/NP | ||
IEC TR 60878:1988 ED1
Graphical symbols for electrical equipment in medical practice
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DELPUB
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EN-FR | U | |||
IEC 60878/AMD1/FRAG1 ED1
Graphical symbols for use on medical equipment - Part 2: Nuclear
medicine
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MERGED
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EN-FR | Y | 62A/171/CDV | ||
IEC 60878/AMD1/FRAG2 ED1
Graphical symbols for use on medical equipment - Part 3:
Radiological equipment
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MERGED
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EN-FR | Y | 62A/172/CDV | ||
IEC TR 60878/AMD1/FRAG2 ED1
VOTING FORM to Graphical symbol: Multi-pulse (60417-IEC-5842 Pr)
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MERGED
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EN | U | 62A/299/CDV |
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IEC TR 60878/AMD1/FRAG3 ED1
VOTING FORM to Graphical symbol: Target position (60417-IEC-5843 Pr)
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MERGED
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EN | U | 62A/300/CDV |
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IEC 60878/AMD1/FRAG3 ED1
Graphical symbols for use on medical equipment - Part 1: General
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MERGED
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EN-FR | Y | 62A/170/CDV | ||
IEC TR 60878/AMD1/FRAG4 ED1
VOTING FORM to Graphical symbol: Body temperature (60417-IEC-5844 Pr)
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MERGED
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EN | U | 62A/301/CDV |
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IEC TR 60878/AMD1/FRAG5 ED1
VOTING FORM to Graphical symbol: Inner diameter (60417-IEC-5845 Pr)
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MERGED
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EN | U | 62A/302/CDV |
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IEC TR 60878/AMD1/FRAG6 ED1
VOTING FORM to Graphical symbol: Outer diameter (60417-IEC-5846 Pr)
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MERGED
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EN | U | 62A/303/CDV |
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IEC TR 60878/AMD1/FRAG7 ED1
VOTING FORM to Graphical symbol: Trend (60417-IEC-5847 Pr)
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MERGED
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EN | U | 62A/304/CDV |
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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
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PPUB
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EN | 2008-09 | N | Webstore | |
IEC TR 60930:1988 ED1
Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment
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DELPUB
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EN-FR | U | |||
IEC TR 61258:2008 ED2
Guidelines for the development and use of medical electrical equipment educational materials
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PPUB
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EN | 2008-09 | N | Webstore | |
IEC TR 61258:1994 ED1
Guidelines for the development and use of medical electrical equipment educational materials
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DELPUB
|
EN-FR | U | 62A(SEC.)/102/CD | ||
IEC 61961 ED1
Safe technology management of electrical equipment for medical
use within health care
|
DEL
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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
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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
|
EN | 2003-10 | N | 62A/398/DTR |
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IEC 62304 ED2
IEC 62304 Ed. 2: Health software - Software life cycle processes
|
CCDV
|
EN-FR | 2022-02 | Y | 62A/1422/CDV |
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IEC 62304/FRAG1 ED2
Medical device software - Software life cycle processes
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MERGED
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EN | 2014-01 | Y | 62A/854A/CC |
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IEC 62304:2006 ED1
Medical device software - Software life cycle processes
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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
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PPUB
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EN | 2015-06 | Y | Webstore | |
IEC 62304/AMD1/FRAGF ED1
Amendment 1 - Medical device software - Software life cycle processes
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MERGED
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FR | Y | |||
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
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PPUB
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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
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DELPUB
|
EN-FR | 2006-07 | N | 62A/506/DTR |
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IEC 62353:2014 ED2
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
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PPUB
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EN-FR | 2014-09 | Y | Webstore | |
IEC 62353:2007 ED1
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
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DELPUB
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EN-FR | 2007-05 | Y | 62A/564/FDIS |
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IEC TR 62354:2014 ED3
General testing procedures for medical electrical equipment
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PPUB
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EN | 2014-10 | N | Webstore | |
IEC TR 62354:2009 ED2
General testing procedures for medical electrical equipment
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DELPUB
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EN | 2009-10 | N | 62A/647/DTR |
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IEC TR 62354:2005 ED1
General testing procedures for medical electrical equipment
|
DELPUB
|
EN-FR | 2006-02 | N | 62A/480/DTR |
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IEC 62366:2007 ED1
Medical devices - Application of usability engineering to medical devices
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DELPUB
|
EN-FR | 2007-10 | Y | 62A/574/FDIS |
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IEC 62366:2007/AMD1:2014 ED1
Amendment 1 - Medical devices - Application of usability engineering to medical devices
|
DELPUB
|
EN-FR | 2013-11 | Y | 62A/889/FDIS |
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IEC 62366-1:2015 ED1
Medical devices - Part 1: Application of usability engineering to medical devices
|
PPUB
|
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
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PPUB
|
EN-FR | U | Webstore | ||
IEC 62366-1:2015/AMD1:2020 ED1
Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
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PPUB
|
EN-FR | 2020-06 | Y | Webstore | |
IEC TR 62366-2:2016 ED1
Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
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PPUB
|
EN | 2016-05 | N | Webstore | |
IEC 63120 ED1
Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle
|
CCDV
|
EN-FR | 2022-02 | Y | 62A/1424/CDV |
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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
|
RFDIS
|
EN | 2021-05 | Y | 62A/1359/CDV |
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IEC 80001-1:2010 ED1
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
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PPUB
|
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 - Practical applications and examples
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PPUB
|
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
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PPUB
|
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
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PPUB
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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
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PPUB
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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
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PPUB
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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
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PPUB
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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
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PPUB
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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
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PPUB
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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)
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PPUB
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EN | 2014-06 | N | Webstore | |
IEC 81001-5-1 ED1
Health Software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle
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CCDV
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EN | 2022-02 | Y | 62A/1419/CDV |
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IEC 82304-1:2016 ED1
Health software - Part 1: General requirements for product safety
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PPUB
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EN-FR | 2016-11 | Y | Webstore | |
ISO 14971:2019 ED3
Medical devices - Application of risk management to medical devices
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PPUB
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EN-FR | 2020-04 | E | Webstore | |
ISO 14971:2007 ED2
Medical devices - Application of risk management to medical devices
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DELPUB
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EN-FR | 2007-04 | N | 62A/558/FDIS |
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ISO 14971:2000 ED1
Medical devices - Risk management - Application of risk management to medical devices
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DELPUB
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EN-FR | Y | 62A/316/FDIS |
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ISO 14971:2000/AMD1:2003 ED1
Amendment 1 - Medical devices - Application of risk management to medical devices
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DELPUB
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EN | N | 62A/412/FDIS |
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ISO TR 17791:2013 ED1
Health informatics -- Guidance on standards for enabling safety in health software
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PPUB
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EN | 2014-02 | N | Webstore | |
ISO TR 24971:2020 ED2
Medical devices - Guidance on the application of ISO 14971
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PPUB
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EN | 2020-07 | E | Webstore | |
ISO TR 24971:2013 ED1
Medical devices -- Guidance on the application of ISO 14971
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DELPUB
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EN | 2013-06 | N | 62A/840/DTR |
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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
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PPUB
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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
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PPUB
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EN | 2015-03 | N | Webstore | |
ISO TR 80002-2:2017 ED1
Medical device software - Part 2: Validation of software for medical device quality systems
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PPUB
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EN | 2017-08 | N | Webstore | |
ISO 81001-1 ED1
Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
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CFDIS
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EN | 2021-04 | E | 62A/1428/FDIS |
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ISO TS 82304-2 ED1
Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice
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ADTS
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EN | 2022-01 | N | 62A/1343/NP |
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