TEXIN 985 sztpu（985年TEXIN sztpu）.pdf

Bayer Corporation ® TEXIN 985 Product Information Thermoplastic Polyurethane Aromatic Polyether-Based Grade Description Manufacturer’s Responsibility: It is the responsibility Texin 985 resin is an aromatic polyether-based of the medical device, biological product or pharmaceutical thermoplastic polyurethane with a Shore hardness of manufacturer (“Manufacturer”) to determine the suitability approximately 85A*. It can be processed by injection of all component parts and raw materials, including molding, extrusion, or blow molding. Texin 985 resin, used in its final product in order to ensure safety and compliance with FDA requirements. Texin 985 natural color resin complies with FDA food- This determination must include, as applicable, testing contact regulations 21 CFR 177.1680 (Polyurethane for suitability as an implant device and suitability as to Resins) and 177.2600 (Rubber Articles Intended for contact with and/or storage of human tissue and liquids Repeated Use), subject to the limitations of these and including, without limitation, medication, blood or any other applicable regulations. In addition, Texin 985 other bodily fluids. Under no circumstances may Texin natural color resin is listed under NSF standard 61 for 985 resin be used in any cosmetic, reconstructive or use in potable water applications. reproductive implant applications. Nor may Texin 985 resin be used in any other bodily implant applications