DIN EN ISO 18113-2:2013-01
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
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 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.
| DevelopmentNote |
Supersedes DIN EN 375. (05/2010)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| 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) |
| DIN EN ISO 15194:2009-10 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
| DIN EN ISO 19001:2013-07 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY (ISO 19001:2013) |
| 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 |
| 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 |
| ISO 18153:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials |
| 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 |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| 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 |
| 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 |
| 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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