Bal Seal Engineering Achieves USP Class VI and ISO 10993-5 Compliance for Medical Sealing Polymers

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Bal Seal Engineering Achieves USP Class VI and ISO 10993-5 Compliance for Medical Sealing Polymers


FOOTHILL RANCH, Calif.–(BUSINESS WIRE)–Bal Seal Engineering, a leading manufacturer of custom-engineered
sealing solutions for medical applications, has achieved USP Class VI
compliance for its SP-191 and SP-23 seal materials. 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, says the achievement validates earlier internal testing, and
that it highlights his 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,” says Wang, “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.”

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.

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, he adds, the polymers will also help streamline
development.

“What this means,” says Wang, “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.”

About Bal Seal Engineering

Bal Seal Engineering, Inc. is a global provider of custom-engineered
sealing, connecting, conducting, and EMI/RFI shielding solutions for
worldwide industry. The company’s products employ 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.

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