MEDICAL MATERIALS
Any material used in medical devices must comply with international quality standards. ISO 13485 governs medical device quality management systems, ensuring that materials and processes meet strict safety and performance requirements. Compliance is critical at every stage of manufacturing, especially for components used in medical equipment and device assemblies.
ISO 13485 COMPLIANT SANTOPRENE TPV
Sherwood Industries Inc. extrudes sheet and profile from Santoprene, a high-performance elastomer, along with other extruded medical grade TPV’s that offer consistent performance, flexibility, and chemical resistance in compliance with ISO 13485 quality standards.
Our extruded sheet and profile are ideal for non-implantable sub-assembly components in the medical industry, including gaskets, seals, housings, and soft-touch grips. By providing ISO 13485 compliant Santoprene extrusions, Sherwood makes it easy for manufacturers to meet regulatory requirements and integrate safe, reliable parts into medical devices.
SHERWOOD’S CAPABILITIES
We can extrude sheet from 0.020” to 0.250” (0.6 mm to 6.3mm) thick. We offer widths between 6” to 36”. Our extruded sheet can be wound onto 3″ or 6″ PVC cores. Our machinery allows for flexibility on the amount of linear feet wound on each roll or a certain weight limit per roll. With four patterns and color matching capabilities, we can provide you with a customized product for your application. We can accommodate orders ranging from 500 pounds to truckloads, shipped worldwide.
We also offer profile extrusion to provide shapes and configurations to match your products’ exact requirements for your unique application. We make custom dies to extrude a shape that fits your requirements and will assure a consistent and reliable part over years of extrusion. Profile parts can be cut to length or wound into a roll.
MEDICAL SPEC SHEETS
Every grade of Santoprene™ TPV has a spec sheet detailing its specifications and properties. For your convenience, we have supplied links to some of the medical spec sheets. Unsure if Santoprene TPV is right for your project? You can learn more about Santoprene TPV and our services regarding sheet extrusion and profile extrusion.
Disclaimer: These specifications listed are for reference only. View the most up to date Celanese specs on the Celanese database called Chemille.