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  • BS EN 62366 : 2008

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2015

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  British Standards Institution

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

    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definition
    4 Principals
    5 USABILITY ENGINEERING PROCESS
    6 ACCOMPANYING DOCUMENT
    7 Training and materials for training
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Categories of USER action
    Annex C (informative) - Examples of USE ERRORS,
            ABNORMAL USE and possible causes
    Annex D (informative) - Guidance on the USABILITY
            ENGINEERING PROCESS
    Annex E (informative) - Questions that can be
            used to identify MEDICAL DEVICE characteristics
            associated with USABILITY that could impact on SAFETY
    Annex F (informative) - Examples of possible USABILITY
            related HAZARDOUS SITUATIONS
    Annex G (informative) - USABILITY goals: Illustrative
            example for a home parenteral infusion pump
    Annex H (informative) - Sample USABILITY SPECIFICATION
            and its inputs
    Annex I (informative) - Recommended reading list
    Annex J (informative) - Reference to the essential principles
    Annex K (normative) - Evaluation of a USER INTERFACE OF
            UNKNOWN PROVENANCE (UOUP)
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EC Directives
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE.

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

    Committee CH/62/1
    Development Note Supersedes 06/30112971 DC. (05/2008) 2008 Edition remains active & will be withdrawn on 14/04/2018. 2008 Edition Re-issued in June 2015 & incorporates AMD 1 2015. Supersedes 12/30269445 DC. (02/2015) Superseded by BS EN 62366-1 and BS PD IEC TR 62366-2 but remains current and will be withdrawn on 31/03/2018. (05/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS PAS 277(2015) : 2015 HEALTH AND WELLNESS APPS - QUALITY CRITERIA ACROSS THE LIFE CYCLE - CODE OF PRACTICE

    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
    AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    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
    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
    IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
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