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Degradation testing is performed to assess how medical device materials break down over time when exposed to physiological conditions, such as those found in the human body. This evaluation is crucial for devices intended for long-term implantation or extended contact with bodily tissues or fluids.
The study focuses on identifying and characterizing chemical, physical, and biological changes that occur in the material during degradation. It also analyzes the nature, quantity, and potential toxicity of the degradation products released. These products may interact with surrounding tissues, and understanding their behavior is vital to ensuring patient safety.
Degradation testing helps predict the long-term performance and biocompatibility of a device, providing essential data for regulatory submissions and risk assessments. Ultimately, it supports the development of safe, effective medical devices by ensuring that material breakdown does not pose harm to the body over time.
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