Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN 60601-1-6:2010

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by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 ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY

    Available format(s):  Hardcopy, PDF

    Superseded date:  09-04-2020

    Language(s):  English

    Published date:  01-01-2010

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

    Add To Cart

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

    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

    Abstract - (Show below) - (Hide below)

    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.

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

    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

    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 9241-210:2010 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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective