Led by China! International Standard for Medical-Grade Silk Fibroin Material Officially Approved for ISO Initiation
On June 4, CCTV's "Morning News" authoritatively reported that two ISO international standards for medical-grade silk fibroin material (ISO/NP 26627) and recombinant collagen, led by China, have been officially approved for initiation. Among these, Xingyue Biotechnology, as a co-developer of the standards, participated in the entire process of drafting, experimental validation, and technical implementation of the international standards. Together with Professor Ouyang Hongwei's team from Zhejiang University, the National Institutes for Food and Drug Control, the Tianjin Medical Device Quality Supervision and Testing Center, and other authoritative institutions, they established the world's first unified quality control specification for medical-grade silk fibroin. This marks official recognition by the International Organization for Standardization (ISO) of China's technical strength in the field of high-end biomedical materials, and the Chinese silk fibroin industry has officially gained a global voice in standard-setting.
The international standard clearly defines requirements for quality evaluation and quality control. It proposes a comprehensive quality control indicator system, ranging from production process control to final product quality control indicators, and specifies detailed testing methods. The standard covers key control aspects such as purity, content, structural characterization, safety testing, stability, and biological evaluation.
Sixteen Years of Accumulated Effort: The "Three-Step Jump" in Standard System Development
This breakthrough did not happen overnight. As early as 2010, Professor Ouyang Hongwei's team at Zhejiang University began promoting the medical translation of silk materials. In 2012, the team led the initiation of industry standard development for silk fibroin materials. In 2020, China's first Class III medical device (the highest level of medical devices) made from silk material was approved for market. In 2024, the group standard "Cosmetic Grade Silk Fibroin" was released and implemented. In October 2025, the national industry standard for medical silk materials, YY/T 1950-2024 "Tissue Engineering Medical Devices – Silk Fibroin", promulgated by the National Medical Products Administration, officially came into effect. From group standards to industry standards, and now to ISO international standards, China has completed a "three-step jump" in the development of the standard system for medical-grade silk fibroin.
From Traditional Silk to High-End Medical Materials: Industrial Transformation and Upgrading
As a traditional advantageous resource in China, silk is gaining new vitality in the modern medical field. Silk fibroin, a natural polymer fibrous protein extracted from silk, has become a star material in tissue engineering and regenerative medicine due to its excellent biocompatibility, controllable biodegradability, and good mechanical properties.
Compared with traditional surgical implant materials, silk fibroin has strong affinity with human tissues and cells, shows no obvious immune rejection, is non-toxic, and can effectively reduce complications such as inflammation and material intolerance. It can provide stable mechanical support during tissue repair and can gradually degrade and absorb after repair is complete, eliminating the need for a second surgery to remove the implant, thereby significantly reducing patient suffering and medical burden. Currently, this material has been widely used in the research, development, and clinical application of high-end medical devices for hernia repair, skin repair, orthopedic sports medicine, and wound dressings.
Helping to Open Up Global Markets and Enhance International Discourse Power
For a long time, the lack of unified and scientific international standards for silk fibroin materials has to some extent constrained the global layout and cross-border technical exchanges of related industries. With the official launch of this international standards project, China's medical bio-based materials industry is facing comprehensive development opportunities. The introduction of the standards will pave an institutional pathway for high-quality domestic medical materials to smoothly enter the international market, comprehensively consolidate China's leading position in the medical silk industry, continuously enhance China's discourse power in international medical device standards, and promote the high-quality development of the biomedical industry.
In emerging fields such as biomaterials, international standardization work has gradually achieved a transition from "following" to "running alongside" and then to "leading." The breakthrough progress of the international standard for silk fibroin materials is not only a high recognition of China's profound scientific research accumulation and industrialization practice in the field of medical-grade silk fibroin but also contributes an authoritative and mature "Chinese solution" to the standardized development of global regenerative medicine materials, with the potential to benefit more patients worldwide.
