Medical die cutting for FDA USP VI silicones produces components for medical devices and equipment that are safe for direct or indirect physical contact with patients. Examples include seals, gaskets, washers, wearables, and diagnostics. FDA USP Class VI silicones aren’t suitable for medical implants, but these specialty elastomers still meet stringent standards for cleanliness and purity.
FDA USP VI silicones for medical devices meet strict standards for cleanliness and purity. The U.S. Food and Drug Administration (FDA) defines its requirements in section CFR 177.2600 of the U.S. Code of Federal Regulations (CFR). The United State Pharmacopeia (USP), a non-profit scientific organization, subjects USP Class VI materials to Biological Reactivity Tests, In Vivo that are directly related to end-use.
Medical silicones that pass these toxicity tests are safe for direct and indirect patient contact. As a medical die cutter, JBC Technologies sources FDA USP VI silicones from a trusted supplier that’s received a Certificate of Compliance (COC) from a leading medical research organization. Unlike some other medical elastomers, these silicones are wholly FDA USP VI compliant – and not just at the ingredient level.
In this article from JBC Technologies, you’ll learn how the way that medical silicones are made determines their cleanliness, purity, and quality. You’ll also learn about the different thicknesses and durometers of the FDA USP VI silicones that JBC can source, convert, and die cut for you.
Medical silicones that pass USP VI Biological Reactivity Tests, In Vivo are safe for direct and indirect patient contact. The United States Pharmacopeia (USP), a non-profit scientific organization, has developed a series of tests to measure the biological response to elastomers, plastics, and other polymeric materials. To simulate the human organism, these tests are performed on mice and rabbit tissue.
Materials in USP Class VI meet the most stringent testing requirements for biological reactivity. USP Plastic Class VI, as this group is also known, includes silicones that pass a systemic toxicity test, an intracutaneous test, and an implantation test. These tests are directly related to the intended end-use of the silicone article. The extractants that are used (such as solutions of alcohol) are typical for medical devices.
JBC Technologies, a medical die cutter, sources high-purity silicones that have a certificate of compliance (COC) for USP VI Biological Tests, In Vivo – USP Plastic Class VI. In this article, the first in a series, you’ll learn where we source these medical materials. You’ll also discover why our supplier’s COC provides our die cutting customers with access to a specialty silicone that can accelerate development times.
The automotive transplant market uses die cut foams and elastomers for isolator pads, gap fillers, seals, gaskets, spacers, liners, and elastomeric springs. Foreign automakers with assembly plants in the United States choose PORON® urethanes and BISCO® silicones from Rogers Corporation for a variety of sealing, cushioning, noise control, vibration management, and gap filling applications.
JBC Technologies, a value-added die cutter, helps car companies chose the right PORON® urethanes and BISCO® silicones for automotive interiors and exteriors. JBC also converts these materials efficiently and supplies die cut products that support automotive assembly. In this article, the last in a series about foams and elastomers from Rogers Corporation, you’ll learn about automotive transplant applications.
Foams and elastomers for the automotive transplant market need to meet demanding requirements from industry organizations and individual automakers. These materials also need to support cost-effective conversion, fast and precise die cutting, and the delivery of die cut products that can help speed assembly operations.
PORON® urethanes and BISCO® silicones are a good choice for sealing, gasketing, and insulation. These elastomers meet SAE-J 1756, ISO-6452, and DIN-75201 standards for fogging. They also meet FMVSS 302, ISO 3795, and DIN 75200 standards for flammability. PORON® urethanes and BISCO silicones® have been emissions tested to VW-50180 and VDA-278, and heat age tested to VW TL-52062 and DBL-5450
JBC Technologies is an automotive die cutter that sources these elastomers from Rogers Corporation and helps you with material selection. In this article, JBC provides an overview of different options.