This International Standard applies to the shelf life testing of in vitro diagnostic medical devices, including reagents, calibration materials, control materials, diluents, buffer solutions and reagent kits, hereinafter referred to as IVD reagents. This International Standard may also apply to primary sample collectors containing substances intended to preserve samples or to stimulate reactions for further processing of the sample in the collector. This International Standard specifies general requirements for shelf life testing and includes specific requirements for real-time and accelerated shelf life testing for the collection of data: to determine the shelf life of IVD reagents, including appropriate transport conditions to ensure that product specifications are maintained; to determine the shelf life of the IVD reagent in use after the primary container is first opened; EXAMPLE Shelf life in the analyzer, Shelf life after recovery, Shelf life of the opened ampoule/bottle; to monitor the shelf life of IVD reagents already placed on the market; to confirm shelf life information after changes to the IVD reagent that could affect its shelf life. This International Standard does not apply to instruments, apparatus, equipment, systems or sample vessels or to the sample submitted for examination.
EN ISO 23640:2015 Referenced Document
ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 23640:2015 history
2015EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
2013EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
2011EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]