Bal Seal Engineering (Foothill Ranch, Calif.) recently announced that it has achieved USP Class VI compliance for its SP-191 and SP-23 seal materials.
The maker of custom-engineered sealing solutions for medical applications also announced ISO 10993-5 compliance for its SP-191, SP-23, and UPC-15 materials.
Compliance with the standards validates Bal Seal‘s earlier internal testing and highlights the company’s ability to solve tough challenges requiring seals that can safely interact with the human body, according to David Wang, global market manager for Bal Seal Engineering’s medical products,
“These materials have supported some of the world’s most advanced medical applications, and they’re proven performers for our customers, who subject them to their own rigorous testing. But these latest results give us an unbiased, accurate means to represent their performance and safety,” Wang said in a March news release.
Bal Seal Engineering went on to explain:
“The United States Pharmacopeia (USP) tests, which were administered by an independent testing authority, evaluated the potential biological effects of the polymer materials. Bal Seal Engineering’s SP-191 and SP-23 materials passed the Class VI test, which is the most stringent. During the International Organization for Standardization (ISO) 10993-5 test, which measured adverse biological effects of extractibles from medical device materials, SP-191, SP-23, and UPC-15 were tested for biological and cytotoxicity responses. They produced no reaction, confirming they are safe for both direct and indirect contact with the human body.
“SP-191 is a filled polytetrafluoroethylene (PTFE) compound, and SP-23 is a high-performance blended polymer with a PTFE base. UPC-15 is an ultra-high molecular weight polyethylene (UHMWPE) material. All three of the materials are frequently employed in the design of the company’s Bal Seal spring-energized seals, which prevent leakage and protect critical components in powered surgical tools, pumps, catheters, and other medical equipment.”
Bal Seal Engineering provides custom-engineered sealing, connecting, conducting, and EMI/RFI shielding components and services for medical device companies around the world. The company touts its Bal Spring canted coil spring technology for enhanced performance and reliability.