Biocompatibility Testing in Medical Devices

Biocompatibility Testing in Medical Devices

Biocompatibility testing for medical devices is the evaluation of the effects of interaction between the tissues and tissues of the patient being treated with the devices as part of the overall safety assessment of the devices. Analytical chemistry, in-vitro tests and animal models are used for this test. There are several factors that affect biocompatibility, such as the chemical and physical nature of the component materials, the types of patient tissue that will be exposed to the devices, and the duration of this exposure.

The In Vitro Cytotoxicity test is one of the tests used to evaluate such harmful reactions.

Individual materials used to make medical devices may be partially biocompatible, but the combination of various materials can cause a toxic reaction. Therefore, the medical device should be evaluated for biocompatibility.

• Cytotoxicity test
• Genotoxicity tests,
• Hemocompatibility test
• Implantation test
• Irritation test
• Sensitization test
• Biodegradation test
• Carcinogenicity test
• Systemic Toxicity tests
• Progenicity test