IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)

Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-01-2013

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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.

Committee	TC 212
DevelopmentNote	Supersedes DIN EN 592. (05/2010)
DocumentType	Standard
Pages	18
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current
Supersedes	DIN EN 592:2002-05 DIN EN ISO 18113-5:2010-05

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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DIN EN ISO 18113-5:2013-01

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