Biocompatible elastomers that are safe for skin contact and for implantation within the human body for less than 29 days.
The SSP2390 Series is a family of platinum-cured USP Class VI silicones ranging from 10 to 80 durometer (Shore A). Our 10-durometer and 50-durometer products have been independently tested by NAMSA and certified by the U.S. Pharmacopeia (USP).
Important: USP Class VI testing was performed with the base elastomer, which is normally translucent. SSP can supply these materials in red, black, gray, and white; however, it is the responsibility of the end user to determine material suitability and regulatory compliance.
SSP’s USP Class VI silicones are biocompatible elastomers that have low levels of extractables, chemicals that can migrate from a material at elevated temperatures or with surface exposure. Items made from USP Class VI silicones cannot be implanted within the human body for longer than 29 days. Consequently, most applications involve contact with skin and living tissue.
USP Class VI is a classification from the U.S. Pharmacopoeia (USP) for plastics and elastomers (including silicones). The purpose is to ensure that materials are safe for biological use. To earn this certification, the silicone must pass a series of tests that evaluate:
Tests are performed animal models, usually rabbits or mice, to ensure the material won’t cause adverse biological reactions.
Applications for USP Class VI certified silicones include:
The U.S. Pharmacopeia (USP), a non-profit organization, defines the requirements for USP Class VI silicones, including a systemic toxicity test, an intracutaneous test, and an implantation test. These tests are related to the material’s end-use and account for conditions such as patient contact time. Although the USP is not a regulatory agency, its standards inform decision-making at the FDA.
USP Class VI biocompatibility requirements aren’t as stringent as those found in ISO-10993, an international standard for the biological evaluation of medical devices. However, testing medical silicones to ISO-10993 is more time-consuming and costly than is necessary for most non-implantable applications.
Technical Specialist, Specialty Silicone Products, Inc.
Last Updated: April 2026