Standards Development

Scope

This document specifies the requirements for characterization and evaluation of silk fibroin used for manufacturing surgical implants, including test items and corresponding test methods, labeling, packaging, shipping, and storage.

This document is intended to be used for the quality assessment and quality control of silk fibroin. This document does not apply for silk fibroin obtained by genetic engineering or transgenic technologies.

Purpose

Natural biomaterials with good biocompatibility and in vivo absorbability are favored in the development trend of tissue engineering materials. Such natural biomaterials have great potential in clinical applications with controlled structural, mechanical, and biodegradable properties. Among them, silk fibroin from natural mulberry silk has not only good biocompatibility, but high mechanical strength and slow degradation rate, low immunogenicity in implantation, vast sources of raw material, easy processing and manufacturing, and can be formed into a variety of scaffolds for tissue repair. Research on the use of silk fibroin for tissue regeneration and product development has received increasing attention. Thus, silk fibroin has great market potential as a valuable biomedical material. In 2008, the US FDA approved silk fibroin surgical patches for breast repair and soft tissue injury repair. In recent years, the number of medical device companies engaged in the research and development of silk fibroin medical products in China has increased, and more silk fibroin-based medical products are emerging. For example, silk fibroin membrane dressing products, silk fibroin trauma dressing products, and absorbable silk fibroin repair films have all obtained product registration certificates. With the increase in the number of silk fibroin medical device products, the characterization and evaluation of this new material is crucial as the basis of product design and development, as well as quality control. Considering the rapid development of the industry, gaps in standards related to silk fibroin production remain in the international area, which limits the development of high-quality silk fibroin in the medical industry. This document was developed to characterize and evaluate the properties and qualities of silk fibroin for ensuring the quality and safety of silk fibroin materials, and providing support for regulation.