Stability

Stability studies support shelf-life and expected lifetime claims. For IVD reagents, stability also covers opened and reconstituted material.

<medical device, accessory> ability to maintain safety and performance characteristics within the specifications in information supplied by the manufacturer (3.10) Note 1 to entry: Stability applies to: — medical devices whose performance, physical, chemical or functional properties can be altered or compromised over a stated time interval; — the period of time over which sterility is assured; — IVD reagents, calibrators and controls, when stored, transported and used in accordance with conditions specified in the information supplied by the manufacturer — reconstituted lyophilized materials, working solutions and material removed from sealed containers, when prepared, used and stored according to the information supplied by the manufacturer; and — measuring instruments or measuring systems after calibration. Note 2 to entry: Stability of an IVD reagent or measuring system is normally quantified with respect to time: — in terms of the duration of a time interval over which a measured property changes by a stated amount; or — in terms of the change of a property under specified conditions.

ISO 20417:2021, clause 3.27