Research status of quality evaluation of collagen medical device products
Collagen is a major structural protein in connective tissue,which has great biocompatibility and biodegradability. In worldwide, the research and development of collagen-related products has become a hotspots. Summarizing the quality and safety detection and evaluation methods is important for the quality control of collagen-related medical devices and products. Firstly, this paper reviewes the application and standardization of collagen. It introduces representative medical device products,such as collagen implants and dressing for hemostasis and healing promotion and, and summarizes the related standardization. Sencondly, focuses on the quality evaluation of collagen, mainly introduces the key indicators such as the type and identification of collagen, protein content analysis and heavy metal detection. The analysis of amino acids and triple helix structures can help identify collagen, and the separate analysis of impurity protein,collagen protein and total protein content can be comprehensive analysis of protein content in collagen products. Finally,this paper summarizes the research and quality evaluation status of collagen,and prospectes the future development. As a widely used biomaterial,the evaluation methods and the quality control criteria of collagen should be enhanced continuously in order to promote the development of related industries.