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    I.S. EN 62366-1:2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  22-08-2019

    Language(s):  English

    Published date:  01-01-2015

    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.

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

    National Foreword
    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles
    5 USABILITY ENGINEERING PROCESS
    Annex A (informative) - General guidance and rationale
    ANNEX B (informative) - Examples of possible HAZARDOUS
            SITUATIONS related to USABILITY
    Annex C (normative) - Evaluation of a USER INTERFACE
            OF UNKNOWN PROVENANCE (UOUP)
    Annex D (informative) - Types of MEDICAL DEVICE use,
            with examples
    Annex E (informative) - Reference to the essential principles
    Bibliography
    Index of defined terms
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications

    Abstract - (Show below) - (Hide below)

    This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop
    and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

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

    Committee TC 62
    Development Note Supersedes I.S. EN 62366. (02/2016) 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    Status Superseded
    Superseded By
    Supersedes

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

    ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
    EN ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    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 Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    ISO 9001:2015 Quality management systems — Requirements
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN ISO 7010 : 2012 AMD 7 2017 GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016)
    EN 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
    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)
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