Name: UNI EN ISO 18113-3 : 2012
Brand: UNI

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

Published date

19-01-2012

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential requirements
5 Labels and marking
6 Elements of the instructions for use
7 Content of the instructions for use
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of the EU
         Directive 98/79/EC on "in vitro Diagnostic Medical
         Devices"

Describes requirements for information supplied by the manufacturer of IVD instruments for professional use.

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 18113-3 : 2010

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

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
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
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
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