Medical-Grade Silicone Products Break Through Biocompatibilit
Keywords: Medical-Grade Silicone, Biocompatibility, Global High-End Medical Market, ISO 10993 Certification, Implantable Silicone
Core Summary: In early April 2026, Shenzhen Huasheng Silicone Medical Materials Co., Ltd. announced that its self-developed implantable medical-grade silicone products have passed ISO 10993 full-series biocompatibility certification, breaking the technical monopoly of international brands and successfully entering the global high-end medical device supporting market.
Medical-grade silicone, especially implantable products, has extremely strict requirements on biocompatibility, including non-toxicity, non-irritation, non-sensitization, and no long-term tissue reaction. For a long time, the global high-end implantable medical silicone market has been dominated by international brands such as Dow Corning and Wacker, as domestic products have been restricted by core technologies such as raw material purity and vulcanization process, making it difficult to meet the strict certification standards of European and American medical markets.
The HS-Med series medical-grade silicone launched by Huasheng Silicone adopts high-purity fumed silica as the main raw material, and optimizes the platinum vulcanization process to effectively reduce the content of residual monomers and impurities, with the purity reaching 99.99%. After testing by authoritative medical testing institutions, the product meets the requirements of ISO 10993-1, ISO 10993-5, and ISO 10993-10, with no cytotoxicity, no skin sensitization, and good tissue compatibility. It can be widely used in implantable medical devices such as breast implants, artificial joints, and medical catheters. At present, the company has signed cooperation agreements with 3 international medical device manufacturers, and the products will be exported to Europe, the United States, and Southeast Asia, with an expected annual sales volume of 500 tons.
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