DIN EN ISO 18113-4:2013-01
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Hardcopy , PDF
01-10-2024
German, English
01-01-2013
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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.
| DevelopmentNote |
Supersedes DIN EN 376. (05/2010)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| 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) |
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