EN 62366-1:2015/AC:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
07-02-2022
18-12-2015
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
Annex A (informative) - General guidance and rationale
ANNEX B (informative) - Examples of possible HAZARDOUS
SITUATIONS related to USABILITY
Annex C (normative) - Evaluation of a USER INTERFACE
OF UNKNOWN PROVENANCE (UOUP)
Annex D (informative) - Types of MEDICAL DEVICE use,
with examples
Annex E (informative) - Reference to the essential principles
Bibliography
Index of defined terms
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Describes a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| Committee |
TC 62
|
| DevelopmentNote |
Supersedes EN 62366. (02/2016)
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| CEI EN 62366-1 : 2016 | Identical |
| BS EN 62366-1:2015 | Identical |
| NF EN 62366-1 : 2015 | Identical |
| NEN EN IEC 62366-1 : 2015 C11 2016 | Identical |
| PN EN 62366-1 : 2015 AC 2016 | Identical |
| DIN EN 62366-1 : 2017 | Identical |
| NBN EN 62366-1 : 2015 COR 2016 | Identical |
| I.S. EN 62366-1:2015 | Identical |
| VDE 0750-241-1 : 2017 | Identical |
| DS EN 62366-1 : 2015 COR 2015 | Identical |
| ONORM OVE EN 62366-1 : 2017 | Identical |
| I.S. EN 62366-1:2015/AC:2015 | Identical |
| 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 |
| DIN EN ISO 11608-7:2015-08 (Draft) | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| 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 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) |
| 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 |
| EN ISO 11608-7:2017 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
| UNE-EN 80369-5:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
| DIN EN ISO 11608-7:2017-10 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| UNE-EN 62304:2007 | Medical device software - Software life-cycle processes (IEC 62304:2006) |
| ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) — Part 11: Guidance on usability |
| ISO 7010:2011 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
| AAMI HE48 : 1993 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
| EN ISO 9241-11:1998 | Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| 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 Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO/TR 16142:2006 | Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| IEC TR 61258:2008 | Guidelines for the development and use of medical electrical equipment educational materials |
| EN ISO 7010 : 2012 AMD 7 2017 | GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016) |
| 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 |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| 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) |
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