Full Description

BS EN ISO 23640:2015 is applicable to the stability evaluation of in vitro diagnostic medical devices, includingreagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ThisInternational Standard can also be applied to specimen collection devices that contain substances used topreserve samples or to initiate reactions for further processing of the sample in the collection device.

This International Standard specifies general requirements for stability evaluation and gives specificrequirements 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 productspecifications are maintained; the establishment of stability of the IVD reagent in use after the first 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 verification of stability specifications after modifications of the IVD reagent that might affect stability.This International Standard is not applicable to instruments, apparatus, equipment, systems or specimenreceptacles, or the sample subject to examination.


Cross References:
ISO 14971
98/79/EC
ISO 18113-1:2009
EN 13640
CLSI EP25-A


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published:

06/30/2015

ISBN(s):

9780580908149

Number of Pages:

16

File Size:

1 file , 990 KB

Same As:

BS EN ISO 23640:2015

Product Code(s):

30326409, 30326409, 30326409

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus