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  • BS EN ISO 18113-3:2011

    Current The latest, up-to-date edition.

    In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2011

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Essential requirements
    5 Labels and marking
    6 Elements of the instructions for use
    7 Content of the instructions for use
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of the EU
             Directive 98/79/EC on "in vitro Diagnostic Medical
             Devices"

    Abstract - (Show below) - (Hide below)

    Describes requirements for information supplied by the manufacturer of IVD instruments for professional use.

    Scope - (Show below) - (Hide below)

    ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use. ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3:2009 can also be applied to accessories, where appropriate.

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

    Committee CH/212
    Development Note Supersedes BS EN 591 and 06/30146518 DC. (02/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    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 14971:2007 Medical devices Application of risk management to medical devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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