DIN EN ISO 18113-5:2013-01
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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 Etiketten und Kennzeichnung
4.3 Form und Gestaltung der Gebrauchsanweisung
5 Inhalt der Gebrauchsanweisung
5.1 Hersteller
5.2 Identifizierung des IVD-Geräts
5.3 Vorgesehene Anwendung
5.4 Lagerung und Handhabung
5.5 Warnhinweise und Vorsichtsmassregeln
5.6 Geräteinstallation
5.7 Kurzbeschreibung der Messung
5.8 Leistung des IVD-Geräts
5.9 Einschränkungen der Anwendung
5.10 Vorbereitung zum Betrieb
5.11 Arbeitsvorschrift
5.12 Kontrollverfahren
5.13 Ablesen der Ergebnisse
5.14 Besondere Funktionen
5.15 Vorgehen beim Ausschalten
5.16 Angaben zur Entsorgung
5.17 Wartung
5.18 Fehlersuche
5.19 Folgemassnahmen
Literaturhinweise
This standard is included in DIN Handbook 378.
| DevelopmentNote |
Supersedes DIN EN 592. (05/2010)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 18113-5:2009 | Identical |
| EN ISO 18113-5:2011 | Identical |
| DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| 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 HDBK 378 : 3ED 2014 | |
| 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 61326-2-6 : 2013 | ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012) |
| IEC 61326-2-6:2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| 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 62366 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: 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) |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| DIN EN 61010-1 : 2011 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| 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 |
| IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - 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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