Technical Guidance Series 2 (Annex to TGS–2) for WHO Prequalification – Diagnostic Assessment: Establishing Component Stability of In Vitro Diagnostic Medical Devices
(2019; 24 pages)


This document was developed by the Prequalification Team – Diagnostic Assessment group in WHO in response to stability concerns found during post marketing surveillance of single-use buffer vials, which are used as a kit component for rapid diagnostic tests (RDTs). The recommendations in the document may be applicable to establishing the stability for any components for IVDs although the examples and emphasis is on the change from establishing stability for multiuse dropper bottles to that for single-use vials. The procedural steps for stability studies are presented in Annex 1 as a policy for illustrative purposes. Precise standard instructions as would be expected in standard operating procedures (SOP) are not provided but rather a listing of what must be done.

The WHO prequalification requirements and basic principles of TGS-2: Establishing stability of in vitro diagnostic medical devices apply equally to the validation of components, and this document is to be read in conjunction with the aforementioned document and TGS-4: Guidance on Test method validation for in vitro diagnostic medical devices.

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