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  • AAMI ISO 15223-2 : 2010

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  12-11-2021

    Language(s):  English

    Published date:  01-01-2010

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of ISO 15223-2:2010
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principles for identification and development of new symbols
    5 Process for selecting and validating symbols for inclusion in
      ISO 15223-1
    6 Classification of risk
    7 Concept development
    8 Evaluation
    9 Acceptance criteria
    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
    Annex C (normative) - IEC/SC 3C proposal for graphical
            symbol form
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes a process for developing, registering, and validating symbols for use in the labeling of medical devices.

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

    Committee WG 03
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    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
    ISO 9186-1:2014 Graphical symbols Test methods Part 1: Method for testing comprehensibility
    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
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