Bal Seal Engineering (Foothill Ranch, California) recently announced that its SP-191 and SP-23 sealing materials have reached USP Class VI standards.
The manufacturer of custom engineered medical sealing solutions also announced that its SP-191, SP-23 and UPC-15 materials comply with the ISO 10993-5 standard.
David Wang, global marketing manager for medical products at Bal Seal Engineering, said that compliance with these standards validates Bal Seal’s early internal testing and highlights the company’s ability to solve the severe challenges that require seals to interact safely with the human body.
“These materials support some of the most advanced medical applications in the world. They are recognized performers for our customers, and they need to perform rigorous testing on them. However, these latest results provide us with a fair and accurate way to Represents its performance and safety.”
“The United States Pharmacopeia (USP) test conducted by an independent testing agency evaluated the potential biological effects of polymer materials. Bal Seal Engineering’s SP-191 and SP-23 materials passed the most stringent level VI test. In the International Organization for Standardization (ISO ) In the 10993-5 test, the test measures the adverse biological effects of extractables in medical device materials, and tests the biological and cytotoxic reactions of SP-191, SP-23 and UPC-15. They did not produce The reaction confirmed that they are safe for direct and indirect contact with the human body.
“SP-191 is a filled polytetrafluoroethylene (PTFE) compound, SP-23 is a high-performance polymer blend with a PTFE base material. UPC-15 is an ultra-high molecular weight polyethylene (UHMWPE) material. These three These materials are often used in the design of the company’s Bal Bal spring-energized seals to prevent leakage and protect key components in electric surgical tools, pumps, catheters and other medical equipment.”
Bal Seal Engineering provides custom-designed sealing, connection, conductive and EMI/RFI shielding components and services to global medical equipment companies. The company touted its Bal Spring inclined spiral spring technology to improve performance and reliability.
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Post time: May-26-2021