09/30191860 DC : 0
Current
The latest, up-to-date edition.
BS EN 60601-1-6 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - USABILITY
Hardcopy , PDF
English
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1 Scope, object and related standards
1.1 Scope
1.2 Object
1.3 Related standards
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Conditions for application to ME EQUIPMENT
4.2 USABILITY ENGINEERING PROCESS for ME EQUIPMENT
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
BS EN 60601-1-6
| Committee |
CH/62/1
|
| DocumentType |
Draft
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| 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 9241-305:2008 | 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 |
| 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 |
| ISO/TR 16982:2002 | Ergonomics of human-system interaction Usability methods supporting human-centred design |
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