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  • DIN EN ISO 18113-4:2013-01

    Current The latest, up-to-date edition.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)

    Available format(s):  Hardcopy, PDF

    Language(s):  German, English

    Published date:  01-01-2013

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Allgemeines
      4.1 Wesentliche Anforderungen
      4.2 Kennzeichnung von Packungsbestandteilen
      4.3 Form und Gestaltung der Gebrauchsanweisung
    5 Inhalt des Etiketts auf dem äusseren Behälter
      5.1 Hersteller
      5.2 Identifizierung des IVD-Reagenz
      5.3 Inhaltsangabe
      5.4 Vorgesehene Anwendung
      5.5 In-vitro-diagnostischer Gebrauch
      5.6 Lagerungs- und Handhabungsbedingungen
      5.7 Verfallsdatum
      5.8 Warnhinweise und Vorsichtsmassregeln
    6 Inhalt des Etiketts auf dem Primärbehälter
      6.1 Allgemeine Bestimmungen
      6.2 Hersteller
      6.3 Identifizierung des IVD-Reagenz
      6.4 Inhaltsangabe
      6.5 Gebrauch für die In-vitro-Diagnostik
      6.6 Lagerungs- und Handhabungsbedingungen
      6.7 Verfallsdatum
      6.8 Warnhinweise und Vorsichtsmassregeln
    7 Inhalt der Gebrauchsanweisung
      7.1 Hersteller
      7.2 Identifizierung des IVD-Reagenz
      7.3 Vorgesehene Anwendung
      7.4 Grundprinzipien des Untersuchungsverfahrens
      7.5 Rückverfolgbarkeit von Kalibriermitteln und
           Kontrollmaterialien der Richtigkeit
      7.6 Bestandteile
      7.7 Zusätzliche besondere Materialien
      7.8 Vorbereitung des Reagenz
      7.9 Lagerung und Haltbarkeit nach dem ersten Öffnen
      7.10 Warnhinweise und Vorsichtsmassregeln
      7.11 Gewinnung, Handhabung und Lagerung von
           Untersuchungsmaterial
      7.12 Untersuchungsverfahren
      7.13 Kontrollverfahren
      7.14 Ablesen der Ergebnisse
      7.15 Auswertung
      7.16 Leistungsmerkmale
      7.17 Biologische Referenzbereiche
      7.18 Einschränkungen des Untersuchungsverfahrens
      7.19 Literaturangaben
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 378.

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

    Committee TC 212
    Development Note Supersedes DIN EN 376. (05/2010)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN HDBK 378 : 3ED 2014
    DIN EN ISO 15223-1:2015-08 (Draft) 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)
    DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
    DIN EN ISO 15197:2015-12 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)

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

    DIN EN ISO 15197:2015-12 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
    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
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    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
    DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
    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
    DIN ISO 15223-1:2006-01 (Draft) 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
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
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