In Vitro Biocompatibility Testing of Biomaterials and Medical Devices

Short-term contact between materials and the body can cause toxicity, irritation, teratogenicity and local inflammation to cells and the whole body; long-term contact may have mutagenic, teratogenic and carcinogenic effects; contact with blood can cause abnormal coagulation function and hemolysis, etc. Therefore, when considering the use of materials in the biomedical field, their biocompatibility is an important indicator that needs to be considered and evaluated.

Biocompatibility test items

biocompatibility testing

Cytotoxicity assay

Sensitization test

Skin irritation test

Intradermal reaction test

Stimulation test

Service Background

Biocompatibility refers to the ability of a material to elicit an appropriate response in a specific part of the body.

● Short-term contact between the material and the body will cause toxicity, irritation, teratogenicity and local inflammation to cells and the whole body;

● Long-term exposure may be mutagenic, teratogenic and carcinogenic;

● Contact with blood can cause abnormal coagulation function and hemolysis, etc.

Therefore, when considering the use of materials in the biomedical field, their biocompatibility is an important indicator that needs to be considered and evaluated.

Evaluation principles and standards

The evaluation of biocompatibility of materials follows the principles of biosafety and biofunctionality, which requires that biomaterials have very low toxicity and can properly stimulate the corresponding functions of the body in specific applications. The evaluation of biocompatibility mainly refers to the requirements of the International Standards Organization (ISO) 10993 and the national standard GB/T16886, and is carried out through a series of in vitro and in vivo experiments.

Biocompatibility testing items and standards

Applicable product range

Medical devices, cosmetics, disposable sanitary products, disinfection products, etc.

General sample requirements

Representative samples. For other specific details, please consult JJR online customer service.