IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011)

Available format(s)

Hardcopy , PDF

Language(s)

German, English

Published date

01-01-2015

Publisher

DevelopmentNote	Supersedes DIN EN 13640. (03/2012) DIN EN ISO 23640 issue 09-2013 remains valid alongside this standard until 30-06-2018. (12/2015)
DocumentType	Standard
Pages	14
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current
Supersedes	DIN EN 13640:2002-06

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
EN 13640:2002	Stability testing of in vitro diagnostic reagents
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
CLSI EP25 A : 1ED 2009	EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
ISO 14971:2007	Medical devices Application of risk management to medical devices