Bal Seal validates SP400HT medical seal material biosecurity

NEWS RELEASE: Bal Seal Engineering expands medical seal materials portfolio with biocompatibility validation of SP400HT

FOOTHILL RANCH, Calif. — Bal Seal Engineering today announced that its SP400HT PTFE sealing material has met the requirements of biocompatibility testing to ISO 10993-5 and USP Plastic Class VI. The testing was conducted by NAMSA, an independent medical device testing laboratory.

SP400HT, a low-friction, polymer-filed PTFE, is part of Bal Seal Engineering’s portfolio of advanced materials for sealing in applications where reliable performance is critical. These applications include medical pumps and ventilators, catheter-driven instruments, syringes, ventricular assist devices, and powered surgical tools.

In ISO 10993-5 cytotoxicity testing, SP400HT received a cytotoxicity grade of 0 and met the requirements of the test. Material extracts also met the requirements of USP Plastic Class VI following systemic toxicity, intracutaneous toxicity, and muscle implantation evaluations.

Calvin Wong, Bal Seal Engineering’s Director of Research and Product Development, says the test results provide additional technical evidence for engineers to consider as part of their own material evaluation and device qualification.

“We know that medical device design is an intense process involving many critical choices,” says Wong. “During that process, engineers need meaningful information like this, so they can have greater confidence in their selection. We’re invested in providing that information.”

SP400HT is the latest in a collection of Bal Seal Engineering’s seal jacket materials to achieve compliance with ISO 10993-5 and USP Class VI requirements. Others include SP191, SP23, and UPC15. For a more detailed look the company’s material offering, visit the resources section of www.balseal.com.

About Bal Seal Engineering

Bal Seal Engineering is a global provider of custom-engineered sealing, connecting, conducting, and EMI/RFI shielding solutions for worldwide industry. The company’s products employ unique Bal Spring canted coil spring technology for enhanced performance and reliability. For the latest news and information about Bal Seal Engineering, visit www.balseal.com or call 800-366-1006.

The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.