Biocompatibility is defined as the capability of a finished and sterilized medical device to perform within an acceptable biological reaction in a clinical application (e.g. skin, blood, tissue/bone, etc.).
Biocompatibility is the most commonly used term to describe appropriate biological requirements of a biomaterial or biomaterials used in a medical device. Biocompatibility is a key concept in understanding the host response to implants and biomaterials.
Biocompatibility testing is an essential requirement for regulatory approval of medical devices such as a medical textile product. Biocompatibility testing is usually performed in accordance with published standards, such as the ISO 10993 series or similar, and comparatively measures the level and time duration of the adverse biological reaction. The evaluation of biological responses to a medical device is a practical approach to determining that the medical device in clinical practice does not introduce an unreasonable harm to the patient or user.
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