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Developed by Bayer MaterialScience LLC (BMS), the non-reinforced, flame-retardant resin is a polycarbonate blend formulated for use primarily in the health care market, specifically for surface device applications contacting intact skin. The resin meets Food and Drug Administration (FDA) ISO 10993-5 for cytotoxicity, and ISO 10993-10 for irritation and sensitization testing requirements. “The material’s combination of physical properties, flame retardance and compliance with these three ISO biocompatibility standards provides medical device and equipment manufacturers with an added safety factor and increased confidence. This, in turn, may potentially streamline the approval process so they are able to bring life-saving products to market more quickly,” said Kevin Dunay, market segment leader, Medical Polycarbonates NAFTA, BMS. Potential applications include insulin pumps and respiratory devices, among others. The resin is supplied in pellet form for injection molding applications and is available in opaque gray. Other opaque colors that utilize biocompatibility tested colorants can also be formulated. The flame-retardant additive to this grade is antimony-, bromine-, and chlorine-free. Bayblend M301 FR polycarbonate/ABS blend is the latest in a long line of material innovations from BMS. For almost 50 years, medical device OEMs and the health care market have relied on BMS’ proven materials and technical expertise. It’s a track record that includes Makrolon polycarbonate utilized for the first blood oxygenators and renal dialyzers in the 1960s. “Our responsiveness to customers, technical expertise, and proven reliability are the main reasons that BMS is viewed as a market leader,” Dunay said. About Bayer MaterialScience Bayer Corporation, headquartered in Pittsburgh, is a subsidiary of Bayer AG, an international health care, nutrition and high-tech materials group based in Leverkusen, Germany. In North America, Bayer had 2007 net sales of 8.1 billion euros and employed 16,800 at year end. Bayer’s three subgroups, Bayer HealthCare, Bayer CropScience and Bayer MaterialScience, improve people’s lives through a broad range of essential products that help diagnose, prevent and treat diseases; protect crops and enhance yields; and advance automobile safety and durability. |
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