In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

22-02-2012

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 129
DevelopmentNote	Supersedes UNE EN 375. (01/2013)
DocumentType	Standard
Pages	20
PublisherName	Asociacion Espanola de Normalizacion
Status	Current
Supersedes	UNE-EN ISO 18113-2:2010 UNE-EN 375:2001

Standards	Relationship
ISO 18113-2:2009	Identical
EN ISO 18113-2:2011	Identical

ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
CLSI GP10 A : 1ED 95(R2001)	ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
ISO 18153:2003	In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 17511:2003	In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
CLSI C28 A2 : 2ED 2000	HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
EN 375 : 2001	INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 18113-3:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008	Symbols for use in the labelling of medical devices