Which category of stability criteria addresses changes in measurable characteristics like elasticity or tensile strength for medical devices?
Answer
Physical.
Medical device stability evaluations cover several distinct areas to ensure functionality and safety over time when stored as directed. The Physical stability criteria specifically focus on measurable alterations in the device's material characteristics that do not necessarily involve chemical breakdown or sterility compromise, but affect performance. This includes tracking changes in observable attributes like the physical appearance, the elasticity of materials, or the tensile strength of components. If these measurable physical properties deviate from established standards due to time or storage factors, the device's shelf life may be deemed terminated, even if chemical purity remains acceptable.
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