Spearheaded jointly by Sichuan University (SCU) and Shanxi Jinbo Bio-Pharmaceutical Co., Ltd, an international standard proposal titled “Medical devices utilizing bioengineered biological substances--Application of risk management” was recently approved for project review by the International Organization for Standardization's Technical Committee on Biological and Clinical Evaluation of Medical Devices (ISO/TC194). Prof. Wang Yunbing, Director of the National Engineering Research Center for Biomaterials and Dean of the College of Biomedical Engineering at SCU, as the project team leader, presented the defense report.

This standard is the world's first international standard for risk management of bioengineered biomaterial medical devices, aiming at regulating and establishing a safety assessment system for medical devices prepared using advanced biotechnology, such as recombinant collagen and synthetic biological materials.The success of this project reflects the international community's recognition of China's technological accumulation and standardization capabilities in this field, and also lays the foundation for China to strive for greater voice in the international competition of biopharmaceutical industry in the future.

In the future, Wang Yunbing will lead project team members, and collaborate with domestic and foreign experts to accelerate the development of a series of standards in this field, promoting the widespread application of Chinese solutions worldwide.