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DIN EN ISO 18113-2:2013-01

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Current

The latest, up-to-date edition.

IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-01-2013

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeines
  4.1 Wesentliche Anforderungen
  4.2 Mindestinformationen
  4.3 Kennzeichnung von Packungsbestandteilen
  4.4 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 oder Bestandteils
  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 Zusätzlich geforderte 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 Berechnung von Untersuchungsergebnissen
  7.15 Auswertung
  7.16 Leistungsmerkmale
  7.17 Biologische Referenzbereiche
  7.18 Einschränkungen des Untersuchungsverfahrens
  7.19 Literaturangaben
Literaturhinweise

This standard is included in DIN Handbook 378.

Committee
TC 212
DevelopmentNote
Supersedes DIN EN 375. (05/2010)
DocumentType
Standard
Pages
20
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

Standards Relationship
ISO 18113-2:2009 Identical
EN ISO 18113-2:2011 Identical

DIN EN ISO 18113-3:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
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)
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CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
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DIN EN ISO 18113-3:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
CLSI C28 A2 : 2ED 2000 HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
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EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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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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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