• 08/30154605 DC : DRAFT APR 2008

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION

    Available format(s): 

    Superseded date:  30-06-2010

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

    Sorry this product is not available in your region.

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles for identification, development and
      selection of new symbols
      4.1 Identifying the need for a symbol
      4.2 Symbols with horizontal applications
      4.3 Symbols for use within a restricted range of
          device types
      4.4 Symbol development process
          4.4.1 General
          4.4.2 Initial evaluation
          4.4.3 Second evaluation
    5 Classification of risk
    6 Concerpt development
      6.1 Existence of other symbols
      6.2 Symbol design
    7 Evaluation
      7.1 Testing early symbol concepts
      7.2 Comprehension testing
      7.3 Memory testing
      7.4 Usability testing
    8 Acceptance criteria
      8.1 General
      8.2 Symbols with no to low safety relevance
      8.3 Symbols with moderate to high safety relevance
    Annex A (normative) - Information to be provided during
            the symbol development process for adoption of
            a symbol into ISO 15223-1
    Annex B (normative) - ISO/TC 145/SC 3 Proposal for graphical
            symbols
      B.1 ISO/TC 145 Symbol proposal form
      B.2 Basic pattern for symbol design
      B.3 ISO/TC 145 registration process steps
    Annex C (normative) - IEC/SC 3 Proposal for graphical symbol
            form
    Bibliography

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

    Comment Closes On
    Committee CH/210/3
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 9186:2001 Graphical symbols Test methods for judged comprehensibility and for comprehension
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    IEC 80416-3:2002+AMD1:2011 CSV Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    ISO 80416-2:2001 Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    ISO/TR 7239:1984 Development and principles for application of public information symbols
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
    • 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