bayer 拜尔技术资料.docxVIP

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MAKROLON? Rx1805 Polycarbonate Resin Lipid-Resistant, Radiation-Stabilized Medical Grade Description Makrolon Rx1805 thermoplastic resin is a transparent polycarbonate formulated to provide increased resistance to chemical attack from IV (intravenous) fluid products, such as lipid emulsions. It also takes advantage of proprietary technology to significantly reduce the discoloration associated with gamma radiation sterilization. The resin is available in clear tint (451118) and selected colors. Applications Makrolon Rx1805 polycarbonate offers an outstanding balance of high strength, toughness, clarity, processibility, and bondability for medical device components. In addition, it offers improved resistance to chemicals typically encoun-tered in a hospital or clinical environment, particularly intravenous lipid emulsions (see table below). Typical IV applications include luer fittings, stopcocks, “Y”-site medication ports, tubing connectors, spikes, and other critical components that may be subjected to high stresses while in contact with these chemicals. Chemical Compatibility with Lipids* Maximum % Elongation Retention Strain Level Rx1805 Standard Polycarbonate 0% 119 117 1% 119 107 1.4% 115 92 2.5% 104 — 5% 64 — Biocompatibility Makrolon Rx1805 resin is designated as “medical-grade” and has met the requirements of the FDA-Modified ISO 10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less. Only “medical-grade” products may be considered candidates for applications requiring biocompatibility. Regrind resins must not be used in medical applications requiring biocompatibility.  Product Information Manufacturer’s Responsibility It is the responsibility of the medical device, biological product or pharmaceutical manufacturer (“Manufacturer”) to determine the suitability of all component parts and raw materials, including Makrolon Rx1805 polycarbonate, used in its final product in order to ensure safety and co

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