A test-based biocompatibility assessment provides reference data that provides a very good basis in the event of unexpected problems and that helps to quickly and directly identify unknown causes. Medical device manufacturers must guarantee the safety of their devices and to minimize potential risks.
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Biocompatibility testing is a set of guidelines and testing parameters for assessment of medical device safety before it comes to market.
Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient's body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.
When medical devices and/or materials come into contact with the patient's body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body.
These effects, called acute to chronic, can result in mutagenic effects.
It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.
These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient's body, such as cells, tissue or body fluids.
Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.
The chemical and physical characteristics of a medical device's component materials, the type of patient tissue that will be exposed to the device, and the duration of the exposure all have a role in its biocompatibility.
When planning for biocompatibility testing, companies must take into account all of the aforementioned considerations.https://www.bridgemedsolutions.com/biocompatibility-and-toxicology/
