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USP Class VI silicones meet stringent biocompatibility requirements that are defined by the United States Pharmacopeia (USP) and recognized by the U.S. Food and Drug Administration (FDA). USP Class VI requires a systemic toxicity test, an intracutaneous test, and an implantation test, all of which are directly related to the end use of the silicone article. The extractants used are typical for medical applications.For manufacturers of medical devices and equipment, it’s important to [...]

Sarah L. Lewis, Ph.D., R&D Manager at Specialty Silicone Products, recently answered questions about REACH compliance and silicone rubber – an important topic for a growing number of silicone buyers.  What is REACH?REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It’s a European Union regulation that’s been in effect since 2007. The European Chemical Agency, or ECHA, is responsible for REACH, which establishes procedures for [...]

Specialty Silicone Products (SSP), a leading manufacturer of EMI and medical silicones, will preview a new USP Class VI conductive elastomer at MD&M West 2020. Qualified visitors to SSP’s booth (#1828) are eligible to receive a prototype sample of an innovative silicone material that meets the most stringent requirements for biological reactivity while combining electrical conductivity with protection against electromagnetic interference (EMI).This special offer is limited to the first [...]

Silicones are used in many healthcare applications, but not all medical silicones are the same. For example, platinum-cured silicones are purer and cleaner than peroxide-cured silicones. Yet choosing the right silicone is about more than just the cure system. Medical manufacturers need high-quality, easy-to-source, on-time, and cost-effective materials. They also need proof that silicones are properly tested and validated. Without this, compliance issues or product recalls may result.  [...]

Specialty Silicone Products (SSP) recently attended MD&M West 2019, the world’s largest annual event for medical device manufacturing. From February 5 to 7, 2019, we met with companies from across the medical device supply chain who were eager to talk about product development, manufacturing, and materials. In case you weren’t able to join us, we’d like to share what we learned at this industry-leading tradeshow in Anaheim, California. The lessons fall into three major [...]