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  • 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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee CH/62/1
    Document Type Draft
    Publisher British Standards Institution
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    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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