Introduction

The Shanghai Biomaterials Research and Testing Center (referred to as the Center) was approved by the Shanghai Municipal Science and Technology Commission and established in June 1989. It is affiliated with the Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine. The center focuses on conducting biological performance testing and evaluation, biocompatibility research, and standardization research on medical devices (including oral equipment) and biomaterials. The center is one of the earliest institutions in China to establish biological evaluation and testing methods for biomaterials. It is a reputable and academically renowned third-party service organization with first-class testing capabilities both domestically and internationally. The center has obtained qualification accreditation from the State Food and Drug Administration (SFDA), laboratory accreditation from the China National Accreditation Service for Conformity Assessment (CNAS), and metrological accreditation from the Quality and Technical Supervision Bureau (CMA), meeting the standard requirements of ISO/IEC 17025 "General Requirements for Testing and Calibration Laboratory Competence". In terms of biological evaluation and testing of medical devices and biomaterials, it has testing capabilities synchronized with ISO. The center relies on the technical support of universities and hospitals, equipped with various advanced testing equipment and high-level professional and technical personnel, thus building a platform to provide testing and consulting services for various domestic and foreign clients.