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    I.S. EN ISO 15223-1:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-07-2020

    Language(s):  English

    Published date:  01-01-2016

    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)

    National Foreword
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Symbols
    Annex A (informative) - Examples
    Annex B (informative) - Use of general prohibition
            symbol and negation symbol
    Bibliography
    Annex ZA (informative) - Relationship between this
            European Standard and the Essential Requirements
            of EU Directive 93/42/EEC [OJ L 169] on Medical Devices
    Annex ZB (informative) - Relationship between this
            European standard and the essential requirements
            of Directive 90/385/EEC [OJ L 189] aimed to be covered
    Annex ZC (informative) - Relationship between this
            European standard and the essential requirements of
            Directive 98/79/EC [OJ L 331] aimed to be covered

    Abstract - (Show below) - (Hide below)

    Defines requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

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

    Committee TC 210
    Development Note Supersedes I.S. EN 980. (07/2012) 2016 Edition Incorporates Corrigendum. (01/2017)
    Document Type Standard
    Product Note CORRECTED VERSION IS NOW AVAILABLE FOR THIS STANDARD The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    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
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
    ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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