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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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
Superseded date
05-08-2021
Superseded by
Published date
22-05-2015
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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Superseded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 |
| Standards | Relationship |
| I.S. EN 60601-1-6:2010/A1:2015 | Identical |
| I.S. EN 60601-1-6:2010 | Identical |
| DIN EN 60601-1-6 : 2016 | Identical |
| NF EN 60601-1-6 : 2010 AMD 1 2015 | Identical |
| NBN EN 60601 1-6 : 2010 AMD 1 2015 | Identical |
| BS EN 60601-1-6 : 2010 | Identical |
| VDE 0750-1-6 : 2016 | Identical |
| UNE-EN 60601-1-6:2010 | Identical |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Identical |
| NEN EN IEC 60601-1-6 : 2010 AMD 1 2015 | Identical |
| CEI EN 60601-1-6:2011/A1:2016 | Identical |
| PN EN 60601-1-6 : 2010 AMD 1 2015 | Identical |
| OVE/ONORM EN 60601-1-6 : 2016 | Identical |
| BS EN 60601-1-6:2010+A1:2015 | Identical |
| 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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