Medical Grades of Uniprene TPV Receive ISO-Standard Approval Critical for International Device Manufacturers

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PAWTUCKET, RHODE ISLAND, U.S.A., February 5, 2002: A series of thermoplastic vulcanizate (TPV) elastomers that can improve the performance of medical devices has achieved approval under the internationally recognized ISO 10993 standard on biocompatibility, it was announced today by the Thermoplastic Elastomer Division of Teknor Apex.

Formulated for medical, food-contact, and potable-water applications, Uniprene (R) 7010 Series compounds can be molded or extruded and range in hardness from 60 Shore A to 50 Shore D. Examples of current and potential applications include syringe plunger tips and seals, vial and pipette stoppers, surgical cable coating, filter elements, tubing, bellows, bulbs, and diaphragms.

"Because they exhibit lower compression set and greater room- and low-temperature elasticity than widely used non-TPV thermoplastic elastomers (TPEs), Uniprene 7010 compounds provide improved performance for peristaltic pump tubing, resuscitator bellows, and other dynamic components that undergo repeated flexure," said Brian Mulvany, Market Manager for Medical and Regulated Products.

Besides achieving approval under ISO 10993, one Uniprene 7010 Series product, a black formulation of Uniprene 7010-64 compound, has already achieved USP Class VI listing, and Mulvany said he expects other grades to follow. All Uniprene 7010 Series products conform to 21 CFR (Title 21 US Code of Federal Regulations) and have been approved for potable-water applications in accordance with NSF Standard 61.