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    I.S. EN 62366-1:2015&AC:2015&A1:2020

    Current The latest, up-to-date edition.

    Medical devices - Part 1: Application of usability engineering to medical devices

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  03-09-2020

    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)

    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

    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 SC 62A
    Document Type Standard
    Product Note The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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