Bal Seal Engineering (Foothill Ranch, CA) recently announced that its SP-191 and SP-23 seal materials have achieved USP Class VI compliance.
The manufacturer of custom engineered sealing solutions for medical applications also announced that its SP-191, SP-23 and UPC-15 materials are ISO 10993-5 compliant.
David Wang, global marketing manager for medical products at Bal Seal Engineering, said that compliance with the standard validates Bal Seal’s early in-house testing and highlights the company’s ability to address the tough challenges of requiring seals that can safely interact with the human body,
“These materials support some of the world’s most advanced medical applications, and they are proven properties for our customers who have rigorously tested them. But these latest results give us an unbiased and accurate way to represent them. performance and safety,” Wang said at a news conference in March.
“United States Pharmacopeia (USP) testing administered by an independent testing agency evaluates the potential biological effects of polymeric materials. Bal Seal Engineering’s SP-191 and SP-23 materials pass the most stringent Class VI testing. ) 10993-5, which measures the adverse biological effects of extractables in medical device materials, tested SP-191, SP-23, and UPC-15 for biological and cytotoxic responses. They did not produce any responses, confirming They are safe for direct and indirect contact with the human body.
“SP-191 is a filled polytetrafluoroethylene (PTFE) compound and SP-23 is a high performance PTFE based polymer blend. UPC-15 is an ultra-high molecular weight polyethylene (UHMWPE) material All three materials are frequently used in the design of the company’s Bal Seal spring-loaded seals, which prevent leaks and protect critical components in powered surgical tools, pumps, catheters and other medical devices.”
Bal Seal Engineering provides custom engineered sealing, joining, conductive and EMI/RFI shielding components and services to medical device companies around the world.The company touts its Bal Spring canted coil spring technology for improved performance and reliability.
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Post time: Jan-15-2022
