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EN ISO 23640:2015

Current
Current

The latest, up-to-date edition.

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
Published date

06-10-2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Procedures
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 98/79/EC
Bibliography

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device. ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; the establishment of stability of the IVD reagent in use after the first opening of the primary container; the monitoring of stability of IVD reagents already placed on the market; the verification of stability specifications after modifications of the IVD reagent that might affect stability.

Committee
CEN/TC 140
DevelopmentNote
Supersedes EN 13640. (01/2012)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

I.S. EN ISO 15197:2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
UNE-EN ISO 15197:2015 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
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

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