• There are no items in your cart

DIN EN ISO 18113-4:2013-01

Current
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

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

This standard is included in DIN Handbook 378.

Committee
TC 212
DevelopmentNote
Supersedes DIN EN 376. (05/2010)
DocumentType
Standard
Pages
20
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

Standards Relationship
ISO 18113-4:2009 Identical
EN ISO 18113-4:2011 Identical

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)

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)

View more information
US$79.81
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.