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  • EN 60601-1-6:2010/A1:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)

    Available format(s): 

    Superseded date:  05-08-2021

    Language(s): 

    Published date:  22-05-2015

    Publisher:  European Committee for Standards - Electrical

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Replacement of requirements given in IEC 62366
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Mapping between the elements of
            IEC 60601-1-6:2006 and the related elements in
            IEC 62366:2007
    Annex C (informative) - References to items of USABILITY
            provided in IEC 62366:2007 and their use in other
            standards
    Bibliography
    Index of defined terms used with this collateral standard
    Annex ZA (normative) - Normative references to international
             publications with their European publications
    Annex ZZ (informative) - Coverage of Essential Requirements of
             EU Directives

    Abstract - (Show below) - (Hide below)

    Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

    General Product Information - (Show below) - (Hide below)

    Committee TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    CEI EN 60601-1-11 : 2016 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
    BS EN 60601-1-11:2015 Medical electrical equipment 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
    I.S. CEN/TS 14507-1:2003 INHALATIONAL NITRIC OXIDE SYSTEMS - PART 1: DELIVERY SYSTEMS
    16/30312315 DC : 0 BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
    BS EN ISO 80601-2-56:2017 Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    09/30192045 DC : 0 BS EN 13544-3:2001/A1 - RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    BS EN 60601-1-12:2015 Medical electrical equipment 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
    09/30192042 DC : 0 BS EN 13544-2:2002/A1 - RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    BS EN 1782 : 1998 TRACHEAL TUBES AND CONNECTORS
    BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
    ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
    BS EN 12342 : 1998 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    BS EN 13544-3 : 2001 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    DIN EN 12342:1998-09 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    DIN EN 12342:2010-01 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    CEN/TS 14507-1:2003 Inhalational nitric oxide systems - Part 1: Delivery systems
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    EN 60601-2-16:2015 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
    17/30338753 DC : 0 BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT
    I.S. EN 60601-1-10:2008 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
    I.S. EN ISO 80601-2-56:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
    I.S. EN 62366-1:2015&AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    EN 60601-1-10:2008/A1:2015 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 (IEC 60601-1-10:2007)
    I.S. EN 60601-2-24:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    I.S. EN 60601-2-16:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    DIN EN 1782:2009-12 TRACHEAL TUBES AND CONNECTORS
    DIN EN 13544-3:2010-01 Respiratory therapy equipment - Part 3: Air entrainment devices (includes Amendment A1:2009)
    DIN EN 13544-2:2010-01 Respiratory therapy equipment - Part 2: Tubing and connectors (includes Amendment A1:2009)
    I.S. EN 13544-3:2001 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    I.S. EN 13544-2:2002 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    I.S. EN 794-3:1998 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    I.S. EN 60601-2-33:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
    VDE 0750-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
    DIN EN 60601-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
    CEI EN 60601-2-24 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS
    BS EN 60601-2-68:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    UNE-EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006)
    BS EN 60601-1-10 : 2008 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
    I.S. EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    I.S. EN 80601-2-30:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    I.S. EN 60601-1-12:2015 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
    DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 60601-2-16:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
    I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    EN 60601-1-12:2015 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
    UNE-EN 1782:1998 TRACHEAL TUBES AND CONNECTORS.
    EN 62366-1:2015/AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
    EN 1782:1998+A1:2009 Tracheal tubes and connectors
    UNI EN 13544-3 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
    UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNI EN 12342 : 2009 BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
    UNI EN 13544-2 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    UNI EN 794-3 : 2009 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    UNI EN 1782 : 2009 TRACHEAL TUBES AND CONNECTORS
    I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
    DD CEN/TS 14507-1:2003 Inhalational nitric oxide systems Delivery systems
    BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
    17/30338756 DC : 0 BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY
    09/30189968 DC : DRAFT JAN 2009 BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
    ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
    CEI EN 60601-2-16 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    I.S. EN 60601-1-11:2015 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
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNE-EN 13544-3:2001 Respiratory therapy equipment - Part 3: Air entrainment devices.
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 794-3 : 1999 LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    BS EN 60601-2-33 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
    EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
    EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    09/30192039 DC : DRAFT JAN 2009 BS EN 794-3 AMD2 - LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS
    BS EN 60601-2-24:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    BS EN 80601-2-30 : 2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
    16/30316718 DC : 0 BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    BS EN 62366-1:2015 Medical devices Application of usability engineering to medical devices
    IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
    EN 60601-1-11:2015 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
    BS EN 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
    EN ISO 80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017)
    EN 60601-2-33:2010/A12:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS
    DIN EN 794-3:2009-12 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009
    BS EN 13544-2 : 2002 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
    EN 13544-3:2001+A1:2009 Respiratory therapy equipment - Part 3: Air entrainment devices
    EN 60601-2-24:2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    EN 80601-2-30:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013)
    UNE-EN 13544-2:2003 Respiratory therapy equipment - Part 2: Tubing and connectors.
    UNE-EN 794-3:1999 LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS.
    UNE-EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 9241-920:2009 Ergonomics of human-system interaction Part 920: Guidance on tactile and haptic interactions
    ISO 9241-400:2007 Ergonomics of humansystem interaction Part 400: Principles and requirements for physical input devices
    ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
    ISO 9241-307:2008 Ergonomics of human-system interaction — Part 307: Analysis and compliance test methods for electronic visual displays
    EN ISO 9241-110:2006 Ergonomics of human-system interaction - Part 110: Dialogue principles (ISO 9241-110:2006)
    ISO 9241-171:2008 Ergonomics of human-system interaction — Part 171: Guidance on software accessibility
    EN ISO 9241-171:2008 Ergonomics of human-system interaction - Part 171: Guidance on software accessibility (ISO 9241-171:2008)
    ISO 9241-110:2006 Ergonomics of human-system interaction Part 110: Dialogue principles
    EN ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998)
    ISO 9241-304:2008 Ergonomics of human-system interaction — Part 304: User performance test methods for electronic visual displays
    EN ISO 9241-20:2009 Ergonomics of human-system interaction - Part 20: Accessibility guidelines for information/communication technology (ICT) equipment and services (ISO 9241-20:2008)
    EN ISO 13407:1999 Human-centred design processes for interactive systems (ISO 13407:1999)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 9241-210:2010 Ergonomics of human-system interaction Part 210: Human-centred design for interactive systems
    ISO 9241-305:2008 Ergonomics of human-system interaction — Part 305: Optical laboratory test methods for electronic visual displays
    EN ISO 9241-400:2007 Ergonomics of human-system interaction - Part 400: Principles and requirements for physical input devices (ISO 9241-400:2007)
    ISO 9241-20:2008 Ergonomics of human-system interaction Part 20: Accessibility guidelines for information/communication technology (ICT) equipment and services
    ISO/IEC 14598-1:1999 Information technology Software product evaluation Part 1: General overview
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO/IEC 14598-6:2001 Software engineering Product evaluation Part 6: Documentation of evaluation modules
    EN ISO 9241-302:2008 Ergonomics of human-system interaction - Part 302: Terminology for electronic visual displays (ISO 9241-302:2008)
    ISO/IEC 14598-4:1999 Software engineering Product evaluation Part 4: Process for acquirers
    ISO/IEC 14598-2:2000 Software engineering Product evaluation Part 2: Planning and management
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO/IEC 15910:1999 Information technology Software user documentation process
    ISO 9241-303:2011 Ergonomics of human-system interaction — Part 303: Requirements for electronic visual displays
    ISO/IEC 18019:2004 Software and system engineering Guidelines for the design and preparation of user documentation for application software
    ISO/IEC 25062:2006 Software engineering Software product Quality Requirements and Evaluation (SQuaRE) Common Industry Format (CIF) for usability test reports
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    EN ISO 9241-300:2008 Ergonomics of human-system interaction - Part 300: Introduction to electronic visual display requirements (ISO 9241-300:2008)
    EN ISO 9241-307:2008 Ergonomics of human-system interaction - Part 307: Analysis and compliance test methods for electronic visual displays (ISO 9241-307:2008)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO/IEC 14598-3:2000 Software engineering Product evaluation Part 3: Process for developers
    ISO 9241-2:1992 Ergonomic requirements for office work with visual display terminals (VDTs) — Part 2: Guidance on task requirements
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 9241-300:2008 Ergonomics of human-system interaction — Part 300: Introduction to electronic visual display requirements
    EN ISO 9241-305:2008 Ergonomics of human-system interaction - Part 305: Optical laboratory test methods for electronic visual displays (ISO 9241-305:2008)
    ISO/IEC 14598-5:1998 Information technology Software product evaluation Part 5: Process for evaluators
    ISO 13407:1999 Human-centred design processes for interactive systems
    EN ISO 9241-410:2008/A1:2012 ERGONOMICS OF HUMAN-SYSTEM INTERACTION - PART 410: DESIGN CRITERIA FOR PHYSICAL INPUT DEVICES (ISO 9241-410:2008/AMD 1:2012)
    ISO 9241-410:2008 Ergonomics of human-system interaction Part 410: Design criteria for physical input devices
    ISO 9241-302:2008 Ergonomics of human-system interaction — Part 302: Terminology for electronic visual displays
    EN 60601-1-8:2007/A11:2017 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 (IEC 60601-1-8:2006/A1:2012)
    ISO/TR 16982:2002 Ergonomics of human-system interaction Usability methods supporting human-centred design
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