Medical device biocompatibility testing is a quality control standard for the development and manufacturing of medical devices. Biocompatibility testing evaluates the effect of a medical device on human tissues to determine whether it can cause biological reactions such as toxicity, physiological, immune, or mutation. Biocompatibility testing is a key process to ensure the safety and effectiveness of medical devices, and also an important link in the approval process for medical devices in many countries.

Why is biocompatibility testing needed?

l Short-term contact between medical devices and the human body can produce toxicity, irritation and local inflammation in cells and the whole body;

l Long-term contact of medical devices with the human body may have mutagenic, teratogenic and carcinogenic effects;

l Contact between medical devices and blood may cause abnormal coagulation function and hemolysis.

Medical device biocompatibility testing helps manufacturers protect patients from any toxic, physiological, immunogenic or mutagenic effects produced by the device.

Sensitization testing

Sensitization testing is used to determine whether medical devices contain chemicals that can cause local or systemic adverse reactions after repeated or prolonged exposure. We use a guinea pig maximization test, closed patch test or murine local lymph node assay to detect the sensitization of medical devices.

Irritation testing

For this test, our company typically uses sites such as skin or mucous membranes in animal models to evaluate the local irritation potential of medical devices.

Heat source testing

Heat source testing evaluates the likelihood that a medical device material will enter the bloodstream and cause a pyrogen reaction or fever. We usually choose the rabbit pyrogen test method.

Implantation testing

This test evaluates the biocompatibility of medical devices that come into direct contact with living tissues other than the skin. The test sample is graded by comparing the difference in the degree of tissue reaction (histopathology) between the test sample and the negative control.

Systemic toxicity

We conduct tests on mice to detect medical devices that may produce systemic (but not local) toxic effects.

Cytotoxicity of cells

This test is mainly used to detect cell-damaging substances in medical devices, thereby assessing the toxicity or potential irritation of medical devices. Our company provides qualitative detection methods (direct contact, AGAR diffusion or MEM elution) and quantitative detection methods (MTT assay).

Genotoxicity testing

We conducted a series of in vitro and in vivo tests to examine whether medical devices contain substances that can directly or indirectly induce genetic damage through a variety of mechanisms. The methods used to detect genotoxicity depend on the intended use of the medical device and the duration of contact with humans. Options include the Ames test, chromosomal aberration, and mouse micronucleus tests.

Blood compatibility testing

For medical devices that come into contact with blood, their blood compatibility must be assessed.