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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
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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 International Standard 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.This International Standard specifes general requirements for stability evaluation and gives specifc 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 specifcations are maintained;- the establishment of stability of the IVD reagent in use after the frst opening of the primary container;EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability.- the monitoring of stability of IVD reagents already placed on the market;- the verifcation of stability specifcations after modifcations of the IVD reagent that might affect stability.This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 23640:2011
Revision Level
2011 EDITION
Status
Superseded
Publication Date
Dec. 19, 2011
Language(s)
English
Page Count
24
International Equivalent
EN ISO 23640:2011(IDT); ISO 23640:2011(IDT)