In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

02-22-2012

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 129
DevelopmentNote	Supersedes UNE EN 376. (01/2013)
DocumentType	Standard
Pages	20
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN 376:2002 UNE-EN ISO 18113-4:2010

Standards	Relationship
ISO 18113-4:2009	Identical
EN ISO 18113-4:2011	Identical

ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
EN 376 : 2002	INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
CLSI GP10 A : 1ED 95(R2001)	ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
CLSI C28 A2 : 2ED 2000	HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
ISO 17593:2007	Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 18113-5:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 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