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09/30191860 DC : 0

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

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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