DIN Standards Committee Health Technologies
DIN EN ISO 23640
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2011
Overview
This 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. It specifies the 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; - the establishment of stability after the first opening of the primary container and - the monitoring of stability of IVD reagents already placed on the market.
Document: references other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
Responsible international committee
ISO/TC 212 - Medical laboratories and in vitro diagnostic systems
