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EN 60601-1-6:2010/A1:2015

EN 60601-1-6:2010/A1:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)

Amendment of

EN 60601-1-6:2010

Superseded date

05-08-2021

Superseded by

EN 60601-1-6:2010/A2:2021

Published date

22-05-2015

Publisher

European Committee for Standards - Electrical

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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

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.

Committee
TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

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

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
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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