Silk Fibroin in Medicine: A Review on ISO10993 Biocompatibility, Preclinical Evidence, and Clinical Perspectives

ABSTRACT Silk fibroin, a natural protein polymer derived from silkworms, has been widely utilized in the development of biomaterials due to its numerous advantageous properties, including versatile processability into various formats, tunable scaffold characteristics, extended biodegradation time, and low immunogenicity in the human body. This review provides a comprehensive overview of the fundamental properties of silk fibroin—such as its thermal, mechanical, optical, and electrical characteristics—offering insights that can guide the tailoring of this material for specific biomedical applications. It also summarizes relevant safety data, including ISO 10993 series evaluations, which confirm the biocompatibility of silk fibroin by demonstrating its low toxicity, blood compatibility, mild inflammatory response, absence of skin sensitization, and lack of systemic toxicity. Furthermore, this review highlights findings from in vivo models across various tissue types, including skin, bone, and nerve, underscoring the high performance of silk fibroin‐based materials in tissue repair and regeneration. Clinical trial reports are also discussed, demonstrating the therapeutic effectiveness, safety, and potential of silk fibroin‐based materials for tissue repair and reconstruction in different organs, thereby reinforcing their translational promise for real‐world medical applications.