New acetal & PBT grades certified for medical use. (Keeping up with Materials).Ticona in Summit, N.J., has introduced 11 grades of Celcon MT (Medical Technology) acetal copolymer and four grades of Celanex MT PBT for medical uses. These FDA-compliant materials are candidates for components of drug-delivery systems, medical devices, and packaging. All these MT grades undergo independent testing to ensure biocompatibility with USP USP - unique sales point 23 Class IV and ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 10993 certifications. Ticona maintains active FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Drug Master Files and Device Master Files for these grades. These 15 MT grades include unreinforced injection and extrusion grades having various flow rates, as well as compounds modified for low friction, wear, and noise. Low-wear grades are also available with PTFE PTFE polytetrafluoroethylene. fillers. Celcon acetal MT grades resist strong disinfectants and many other chemical media. Celanex PBT MT grades have a relatively high continuous-use temperature and good resistance to acids, greases, solvents, and gamma sterilization. Tel: (800) 833-4882, www.ticona.com. |
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