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Device Stress Problem Evaluation Result
Device problems caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.g. wear, bending, deformation, fracture, fatigue. (Food and Drug Administration)
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Testing the device's ability to resist forces that attempt to break or deform the device. This evaluation includes testing tension such as…
Device problems that result from storing the device in an uncontrolled or improper environment (e.g., moisture sensitive devices stored in a humid…
Performing a review of the storage and shipping processes and requirements.
A device problem that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force. …
Performing a review of the records and processes used to render a product free from viable microorganisms.
Verifying that the methods used to free a medical device from viable microorganisms such as fungi, bacteria, and viruses were followed. …
