I.S. EN 60601-1-6:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
04-09-2020
English
01-01-2010
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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.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
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| DocumentType |
Standard
|
| Pages |
29
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| PublisherName |
National Standards Authority of Ireland
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| Status |
Superseded
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| SupersededBy |
| Standards | Relationship |
| EN 60601-1-6:2010/A1:2015 | Identical |
| BS EN 60601-1-6 : 2010 | Identical |
| UNE-EN 60601-1-6:2010 | Identical |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Identical |
| DIN EN 60601-1-6 : 2016 | Identical |
| NF EN 60601-1-6 : 2010 AMD 1 2015 | Identical |
| 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 |
| ISO 9241-171:2008 | Ergonomics of human-system interaction — Part 171: Guidance on software accessibility |
| ISO 9241-110:2006 | Ergonomics of human-system interaction Part 110: Dialogue principles |
| ISO 9241-304:2008 | Ergonomics of human-system interaction — Part 304: User performance test methods for electronic visual displays |
| 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 |
| 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 |
| 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 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 |
| 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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