Standards and quality control points of alginate-based medical devices / 中国修复重建外科杂志

ABSTRACT

Objective: To analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about. Methods: Based on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed. Results: With the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards. Conclusion: Considering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-L-guluronic acid to β-D-mannuronic acid of alginate, and impurity content.