SAFETY CONSIDERATIONS

GENERAL Wear safety glasses and/or face shields when thermoforming any Bayer thermoplastic sheet and use proper gloves and other appropriate garments when handling hot tools and auxiliary equipment.

HEALTH AND SAFETY PRECAUTIONS Appropriate literature has been assembled which provides information concerning health and safety precautions that must be observed when handling Bayer Corporation products mentioned in this publication. Before working with any of these products, you must read and become familiar with the available information on their hazards, proper use, and handling. This cannot be overemphasized. Information is available in several forms, e.g., material safety data sheets (MSDS) and product labels. Consult your local Bayer Corporation representative or contact the Bayer Product Safety and Regulatory Affairs Department in Pittsburgh, Pennsylvania at 412-777-2000. For materials that are not Bayer Corporation products, appropriate industrial hygiene and other safety precautions recommended by their manufacturer(s) must be followed.

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radiation. and/or film. or other bodily fluids. blood. biological product. Under no circumstances should degraded. reconstructive. without limitation. NSF. Therefore. and external loads. without limitation. sprues. sterilization method. trimmings. All regrind used must be clean. 61 of 77 .GENERAL INFORMATION REGULATORY COMPLIANCE Some of the end-uses of the products described in this brochure must comply with the applicable regulations. or contaminated material be used for regrind. uncontaminated. This determination must include. and processing parameters. If you have questions on the regulatory status of any Bayer thermoplastic sheet. blood. and CPSC. including Bayer resins. the manufacturer must evaluate each application to determine the sterilization method and the number of cycles for exact end-use requirements. or dry heat. Pennsylvania. for greater than 30 days. The suitability of a Bayer product in any given end-use environment is dependent upon various conditions including. runners. such as methylene dianiline (MDA). MEDICAL GRADE INFORMATION It is the responsibility of the medical device. and thoroughly blended with virgin resin prior to drying and processing. Parts thermoformed from Makrolon polycarbonate and Lustran ABS sheet are sterilizable using ethylene oxide. part design. REGRIND USAGE Where end-use requirements permit. such as the FDA. testing for suitability as an implant device and suitability as to contact with and/or storage of human tissue and liquids including. or any applications involving contact with or storage of human tissue. USDA. Under no circumstances may any Bayer resin be used in any cosmetic. Materials of this type should be discarded. regrind may be used with virgin material in quantities specified in individual product information bulletins. as applicable. Any regrind used must be generated from properly molded/ extruded parts. chemical compatibility. or other bodily fluids. discolored. Steam sterilization methods must not be used with aromatic grades of Makrolon polycarbonate and Lustran ABS because possible hydrolysis of solid urethane may produce aromatic amines. temperature. provided that the material is kept free of contamination and is properly dried (see drying conditions in product information bulletins). Part 1 “Biological Evaluation of Medical Devices” tests. STERILIZATION INFORMATION The sterilization method and the number of sterilization cycles a part made from Makrolon polycarbonate and Lustran ABS can withstand will vary depending upon the type and grade of resin. please contact your local Bayer Corporation representative or the Bayer Corporation Regulatory Affairs Manager in Pittsburgh. It is the responsibility of the manufacturer to evaluate its final product under actual end-use requirements and to adequately advise and warn purchasers and users thereof. or reproductive implant applications. used in its final product in order to ensure the safety and compliance with FDA requirements. part design. based on FDA-Modified ISO 10993. medication. residual stresses. or pharmaceutical manufacturer to determine the suitability of all component parts and raw materials. Nor may any Bayer resin be used in any other bodily implant applications.

material currently being used. it is your responsibility to conduct enduse testing and to otherwise determine to your own satisfaction whether Bayer Corporation products and information are suitable for your intended uses and applications. Bayer Corporation will furnish such technical advice or assistance it deems to be appropriate in reference to your use of our products. It is expressly understood and agreed that. applicable government or regulatory agency test standards. So that we can respond efficiently to your inquiry.TECHNICAL SUPPORT To get material selection and/or design assistance. such as mechanical stress and/or strain. For assistance. types of chemicals to which the part(s) may be exposed. and productivity audits. we can provide processing assistance nationwide through a network of regional Field Technical Service Representatives. since all such technical advice or assistance is rendered without compensation and is based upon information believed to be reliable. start-up and troubleshooting support. Building 8 Pittsburgh. PA 15205-9741 Phone: 412-777-2000 62 of 77 . We can help customers optimize the quality and performance of their parts by offering the following types of assistance: on-site processing. and any other restrictive factors or pertinent information of which we should be aware. or call or write us at the following address: Bayer Corporation Polymers Division. contact any of our regional sales offices listed on the back cover. In addition. if possible. peak and continual service temperature. equipment. and tool design. Plastics 100 Bayer Road. just write or call and let us know who you are and what your needs are. stiffness required to support the part itself or another item. here are some of the points of information we would like to know: physical description of your part(s) and engineering drawings. impact resistance and assembly techniques. Upon request. service requirements. the customer assumes and hereby expressly releases Bayer Corporation from all liability and obligation for any advice or assistance given or results obtained. Moreover. tolerances that must be held in the functioning environment of the part(s).

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