Focus on testing, inspection, certification, research and development, and strive to be a world-class testing, inspection, certification, research and development institute
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Biocompatibility test refers to the concept of all kinds of organisms, physics, chemistry effects caused by the interaction between raw materials and organisms.
Scientific research in a laboratory with animals for acquirement of new knowledge about biology, medicine, or solving specific problems before clinical experiment.
The Medical Device Division strives to provide services for biocompatibility, chemical characterization (leachables study) preclinical large animal experimental research, physico-chemical properties testing and microbial test of implantation and outer communication products classified as category II and III. It is complied with global regulations implementation of GLP quality system of OECD, FDA, NMPA and ISO.
Leachables generally refer to the substances released from medical devices or materials during clinical use, including sterilization residues, process residues, degradation products, monomers and additives (antioxidants, stabilizers, plasticizers).
Material characterization, reveal and determine the structural characteristics of materials by physical and chemical methods
The manufacturers of none-diaposable medical devices that need to be sterilized, should provide at least one confirmed sterilization method, the process of which will be validated (sterilization validation).