IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)

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 Theoretische Grundlagen der Arbeitsweise
  5.8 Funktionen
  5.9 Leistung des IVD-Geräts
  5.10 Einschränkungen der Anwendung
  5.11 Vorbereitung zum Betrieb
  5.12 Arbeitsvorschrift
  5.13 Kontrollverfahren
  5.14 Berechnung der Untersuchungsergebnisse
  5.15 Besondere Funktionen
  5.16 Notfall-Untersuchungsmaterial und -proben
  5.17 Vorgehen beim Ausschalten
  5.18 Angaben zur Entsorgung
  5.19 Wartung
  5.20 Fehlersuche
Literaturhinweise

This standard is included in DIN Handbook 378.

Committee	TC 212
DevelopmentNote	Supersedes DIN EN 591. (05/2010)
DocumentType	Standard
Pages	18
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current
Supersedes	DIN EN ISO 18113-3:2010-05

Standards	Relationship
ISO 18113-3:2009	Identical
EN ISO 18113-3:2011	Identical

DIN HDBK 378 : 3ED 2014
DIN EN ISO 18113-2:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
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 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)
EN 591 : 2001	INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
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
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)
DIN EN ISO 18113-2:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
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
ISO 18113-2:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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
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 18113-3:2013-01

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