Biocompatibility Testing

In Vitro Biocompatibility Testing

We conduct a broad spectrum of in vitro biocompatibility testing to assess the biological response of medical devices to the human body. This includes testing for cytotoxicity, genotoxicity, and hemocompatibility, among others.

• Cytotoxicity Testing

The primary purpose of cytotoxicity testing is to evaluate how a medical device or material interacts with living cells and tissues. By identifying and mitigating potential cytotoxic effects early in the development process, manufacturers can produce medical devices that meet the highest standards of biocompatibility and contribute to improved patient outcomes.

• Genotoxicity Testing

Genotoxicity testing is a critical component of medical device biocompatibility testing. It involves assessing the potential of medical device materials or components to cause damage to genetic material, such as DNA, within living cells. This type of testing is crucial for evaluating the safety of medical devices, as genotoxic effects can lead to mutations, chromosomal abnormalities, or even carcinogenesis in exposed individuals.

• Hemocompatibility Testing

Hemocompatibility testing is essential for evaluating the safety and performance of medical devices that come into contact with blood, such as vascular implants, extracorporeal devices, and blood-contacting materials. The test is designed to ensure that medical devices do not cause adverse reactions or harm to blood components (e.g., red blood cells, platelets, or plasma proteins) when in contact with circulating blood.

In Vivo Biocompatibility Testing

We are also able to perform extensive in vivo biocompatibility testing. These tests include, but are not limited to, the following:

• Irritation Testing

Irritation testing involves evaluating the potential of medical device materials or components to cause irritation or inflammation when in contact with living tissues.

• Pyrogen Testing

Pyrogen testing involves assessing the presence of pyrogens, which are substances that can induce fever when introduced into the bloodstream. Pyrogens can originate from various sources, including bacterial endotoxins, microbial contaminants, or certain chemical substances, and their presence in medical devices can pose significant health risks to patients.

• Implantation Testing

Implantation testing involves assessing the biocompatibility and safety of medical devices when implanted into living tissues or organisms.

• Sensitization Testing

Sensitization testing involves assessing the potential of medical device materials or components to induce allergic or hypersensitivity reactions in exposed individuals.