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  • BS EN ISO 18113-4:2011

    Current The latest, up-to-date edition.

    In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-01-2012

    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 General
    5 Content of the outer container label
    6 Content of the immediate container label
    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 reagents for self-testing.

    Scope - (Show below) - (Hide below)

    This part of ISO18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO18113 can also be applied to accessories. This part of ISO18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO18113 does not apply to: IVD instruments or equipment, IVD reagents for professional use.

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

    Committee CH/212
    Development Note Supersedes BS EN 376 and 06/30146522 DC. (02/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
    CLSI C28 A2 : 2ED 2000 HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    EN 980:2008 Symbols for use in the labelling of medical devices
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