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Medical-grade fluorosilicone rubber undergoes iterative upgrades, driving the development of compliance and high-performance industries. 

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Medical-grade fluorosilicone rubber undergoes iterative upgrades, driving the development of compliance and high-performance industries. 

1.Upgrading industry standards to establish a solid safety foundation for medical materials

With the advancement of medical equipment towards intelligence and precision, the safety standards for medical-grade fluorosilicone rubber continue to tighten, and the compliance requirements for the industry are constantly rising. Recently, relevant departments have further improved the technical specifications for medical fluorosilicone rubber, clearly stipulating that implantable and contact products must pass the full-item biological safety certification of ISO 10993, strictly limiting the content of cyclic siloxanes (D4–D6) and leachable substances, and setting higher requirements for product cleanliness and sterility, promoting the transformation of the medical-grade fluorosilicone rubber industry towards standardization and high quality. 

2. Performance Optimization: Adaptation to High-End Medical Scenario Requirements
In response to the demanding usage scenarios in the medical field, the performance of medical-grade fluorosilicone rubber has been continuously upgraded. The new products have achieved multiple breakthroughs in terms of biocompatibility, sterilization resistance, and long-term stability through formula optimization and process improvement. They can withstand various sterilization methods such as gamma rays, high temperature and high pressure, and do not yellow or release low-molecular substances after sterilization. After being immersed in simulated body fluids for a long time, the mechanical performance degradation is controlled within a reasonable range, making them suitable for high-end scenarios such as minimally invasive surgical equipment, in vitro diagnostic instruments, and implantable devices. 

3. Application Expansion: Covering Multiple Medical Device Fields
The application scope of medical-grade fluorosilicone rubber is continuously expanding and has deeply penetrated into various medical device manufacturing processes. From the sealing components of conventional medical devices such as syringes and infusion sets, to the core sealing parts of medical centrifuges and ECMO equipment, as well as the packaging materials for implantable medical devices such as artificial heart pumps and cardiac pacemakers, its outstanding physiological inertness and chemical corrosion resistance have been fully utilized, becoming a key material for ensuring the safety and reliability of medical equipment. 

4. Rising demand drives high-quality development in specialized segments
Thanks to the upgrading of the global medical health industry and the promotion of domestic production of high-end medical devices, the demand for medical-grade fluorosilicone rubber has continued to rise. Data shows that in recent years, the growth rate of the medical-grade fluorosilicone rubber market has remained above 18%, with the demand for high-end products for implantable devices increasing by more than 20%. Industry enterprises have been increasing their research and development investment, focusing on compliant production and the development of high-performance products, driving the high-quality development of the specialized segment of medical-grade fluorosilicone rubber.

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