This document specifies general and specific requirements for evaluating the stability of in vitro diagnostic (IVD) reagents, including reagents, calibrators, control materials, and reagent kits. It also applies to specimen collection devices containing substances for sample preservation or processing. The document covers real-time and accelerated stability testing and provides guidance on establishing shelf life, transport conditions, in-use stability after opening, market monitoring, and verifying stability after modifications to ensure product reliability.