In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

ISO 23640:2011

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

This international standard 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. 

This document is available in electronic format only. 

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Publication Details

Date of Publication: December 1, 2011

Order Code PDF: ISO23640E

Order Code Print: print not available

Edition: First

Pages: 7

ISO 23640:2011 Additional Details

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. 

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems