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 23640:2013
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2013
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 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 new edition of the standard has been initiated by the required revision of Annex ZA.
Document: references other documents
Document: referenced in 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
