Biocompatibility test services of medical device

 

Category:

Exhibitor: LEVEL BIOTECHNOLOGY INC.

Booth No: M320

 

Characteristic

 

Level Biotechnology Preclinical Testing Center provides biocompatibility testing of medical devices and biomedical materials, which complies with relevant regulations of the TFDA, ISO 10993, and USFDA. With the animal management system certified by AAALAC International and the reliable quality of TAF OECD GLP, ISO 17025, and ISO 9001:2000 certification, we provide fast service and professional consultation. At present, customers have successfully registered applications in the United States and the European Union.
Biocompatibility is to evaluate the response of medical devices or biomedical materials to the human body when they come into direct or indirect contact with the human body. The main basis of the test is ISO 10993 "Biocompatibility Evaluation of Medical Devices". According to the chemical characteristics of medical device materials, the nature, degree, frequency, and time of contact with the human body, a series of tests are designed as the evaluation criteria. The following is the service item:
-Cytotoxicity Testing
-Hemocompatibility Testing
-Sensitization Testing
-Irritation Testing
-Acute Systemic Systemic Study
-Pyrogen Tests
-Genetic Toxicity Studies
-Implantation Testing
-Subacute/Subchronic Toxicity
-Carcinogenicity

 

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