Introduction

The Shanghai Biomaterials Research and Testing Center (hereinafter referred to as the Center) was approved and established by the Shanghai Municipal Science and Technology Committee in June 1989, with its predecessors being the Oral Materials Research Laboratory of Shanghai Second Medical University (established in 1960) and the Biomedical Materials Research Laboratory of Shanghai Second Medical University (established in 1982). The Center focuses on conducting research, testing, evaluation, and standardization work related to the biocompatibility of medical devices (including dental equipment) and biological (dental) materials. As one of the earliest institutions in China to establish biological evaluation and testing methods for biomaterials, the Center enjoys a prestigious reputation both domestically and internationally as an external service organization that combines academic standing with first-class testing capabilities.

The Center serves as the Deputy Director of the Biocompatibility Evaluation Branch of the Chinese Society for Biomaterials, the 2nd and 7th Chairman of the Dental Materials Professional Committee of the Chinese Stomatological Association, the Chairman of the 4th National Technical Committee on Standardization for Contraceptive and Obstetrics-Gynecology Devices (TC169), as well as a member of the National Technical Committee on Standardization for the Biological Evaluation of Medical Devices (TC248) and the National Technical Committee on Standardization for Dental Materials and Equipment (TC99). It is also an expert unit for the standardization of medical devices for medical and hygienic materials and dressings. The Center has obtained accreditation from the National Medical Products Administration (NMPA), China National Accreditation Service for Conformity Assessment (CMA), and China National Accreditation Service for Conformity Assessment (CNAS) for inspection and testing institutions, meeting the standard requirements of ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories." In the field of biological evaluation of medical devices/biomaterials, it not only possesses testing capabilities synchronized with national or industry standards in China but also leads the industry with testing capabilities synchronized with international standards such as ISO. The Center has provided biological evaluation and testing services for over 18,500 domestic and international medical device products of Class I, II, and III.

Occupying approximately 1,600 square meters, the Center comprises various laboratories including an animal laboratory (with operating rooms and observation rooms), a Class 10,000 clean room, a toxicology laboratory, a hemocompatibility laboratory, an immunology laboratory, a histopathology laboratory, a genotoxicity laboratory, a biodegradation laboratory, an instrument analysis room, and a molecular biology laboratory. Additionally, the Center boasts a SPF-level animal laboratory that meets national standards.

Over the past 35 years, the Center has conducted domestically leading and internationally synchronized research focusing on the development of medical devices (including dental equipment) and biological (dental) materials, the exploration of the interaction between materials and the body and its mechanisms, the formulation and revision of national and industry standards, and the evaluation of the biological safety of materials. It has completed over 70 research projects, winning more than 10 scientific and technological achievement awards. In recent years, in particular, the Center has undertaken over 50 national projects such as the "863" Program, the Ministry of Science and Technology's Key Research and Development Program, the National Natural Science Foundation, projects from the Ministry of Education, the Ministry of Health, and the Shanghai Municipal Government. It has obtained 17 national invention patents, drafted 2 national standards, 12 industry standards, and published over 200 academic papers, including 72 SCI-indexed papers. Relying on the technical support of universities and hospitals, the Center possesses various advanced testing equipment and high-level professional technicians. To meet the demands of medical device industry development under new circumstances, the Center is equipped with the capability to provide testing services for various innovative medical devices and has established a platform for research, testing, and consulting services for clients both domestically and internationally.