• PD IEC/TR 62366-2:2016

    Current The latest, up-to-date edition.

    Medical devices Guidance on the application of usability engineering to medical devices

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  27-04-2016

    Publisher:  British Standards Institution

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

    FOREWORD
    INTRODUCTION
    1 Scope and purpose
    2 Normative references
    3 Terms and definitions
    4 Mapping between the requirements of IEC 62366-1
       and the guidance of IEC TR 62366-2
    5 Background and justification of the USABILITY
       ENGINEERING program
    6 How to implement a USABILITY ENGINEERING program
    7 Overview of the USABILITY ENGINEERING PROCESS
    8 Prepare the USE SPECIFICATION
    9 Identify USER INTERFACE characteristics related
       to SAFETY and potential USE ERRORS
    10 Identify known or foreseeable HAZARDS and HAZARDOUS
       SITUATIONS
    11 Identify and describe HAZARD-RELATED USE SCENARIOS
    12 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE
       EVALUATION
    13 Establish USER INTERFACE SPECIFICATION
    14 Establish USER INTERFACE EVALUATION plan
    15 Design and implement the USER INTERFACE and training
    16 Perform FORMATIVE EVALUATIONS
    17 Perform SUMMATIVE EVALUATION
    18 Document the USABILITY ENGINEERING project
    19 POST-PRODUCTION review and analysis
    Annex A (informative) - Recommended reading list
    Annex B (informative) - External resources to identify
            known problems
    Annex C (informative) - Developing USABILITY GOALS for
            commercial purposes
    Annex D (informative) - USABILITY ENGINEERING project
            end products
    Annex E (informative) - USABILITY ENGINEERING methods
    Annex F (informative) - USABILITY ENGINEERING studies
            in clinical settings
    Annex G (informative) - USER PROFILE
    Annex H (informative) - USE ENVIRONMENT descriptions
    Annex I (informative) - USER INTERFACE REQUIREMENTS
    Annex J (informative) - Model the USER INTERFACE
    Annex K (informative) - USABILITY TEST sample size
    Annex L (informative) - Identifying distinct USER groups
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Gives background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY.

    Scope - (Show below) - (Hide below)

    IEC TR 62366-2:2016(E), which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.

    This publication is to be read in conjunction with IEC 62366-1:2015.

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

    Committee CH/62/1
    Development Note Together with BS EN 62366-1, it supersedes BS EN 62366 which remains current and will be withdrawn on 31/03/2018. (05/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 9241-110:2006 Ergonomics of human-system interaction Part 110: Dialogue principles
    ISO/TR 24971:2013 Medical devices Guidance on the application of ISO 14971
    AAMI TIR50 : 2014 POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
    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
    ISO 16781:2013 Space systems Simulation requirements for control system
    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/TS 19218-1:2011 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 14915-1:2002 Software ergonomics for multimedia user interfaces Part 1: Design principles and framework
    ISO 14915-3:2002 Software ergonomics for multimedia user interfaces Part 3: Media selection and combination
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 82079-1:2012 Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements
    AAMI TIR49 : 2013 DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
    ISO 14915-2:2003 Software ergonomics for multimedia user interfaces — Part 2: Multimedia navigation and control
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