FOOTHILL RANCH, Calif.—Bal Seal Engineering Inc., a manufacturer of custom-engineered sealing for medical applications, has achieved USP Class VI compliance for its SP-191 and SP-23 seal materials, the company reported. It has also achieved ISO 10993-5 compliance for its SP-191, SP-23, and UPC-15 materials.
David Wang, global market manager for Bal Seal Engineering’s medical products, said that the achievement validates earlier internal testing and highlights the company’s ability to solve tough challenges requiring seals that can safely interact with the human body.
“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,” said Wang in a company release. “But these latest results give us an unbiased, accurate means to represent their performance and safety.”
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 extractables 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, the company said.
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.
According to Wang, the results will allow designers to confidently incorporate Bal Seal Engineering’s sealing materials into a broader range of medical devices, including short and long-term implantables. As “compliant” materials, the polymers will also help streamline development, he added.
“What this means is that medical OEMs and tier suppliers can feel even better about using our seals to achieve new levels of device performance, reliability, and safety,” said Wang.
Bal Seal Engineering, Inc. (www.balseal.com) is a global provider of custom-engineered sealing, connecting, conducting, and EMI/RFI shielding products for worldwide industry. The company’s products employ Bal Spring® canted coil spring technology, which enables enhanced performance and reliability, the company said.