TEFLON® fibers can be processed at elevated temperatures without hazard if proper ventilation is used. However, if adequate ventilation is not provided and workers inhale the fumes from overheated TEFLON® fibers in sufficient quantities, influenza-like symptoms may follow. These symptoms do not ordinarily occur until several hours after exposure, and disappear within 36 to 48 hours, even in the absence of treatment.

Observations indicate that these occurrences do not have any lasting effects and that the effects are not cumulative. However, their occurrence indicates that ventilation is inadequate and should be improved. When such symptoms occur they usually follow exposure to vapors evolved from the polymer at 545°F (285°C) or above, or from smoking tobacco or cigarettes contaminated with the polymer. There is no record of workers being seriously injured by fumes from heated TEFLON® or by its thermal decomposition products.

For more detail, refer to the Material Safety Data Sheet (MSDS) for TEFLON® fibers, available upon request.

Do not use TFA materials in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.

Do not use TFA materials in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues, unless the material has been provided directly from TFA under a contract which expressly acknowledges the contemplated use.

TFA makes no representation, promise, express warranty or implied warranty concerning the suitability of these materials for use in implantation in the human body or in contact with internal body fluids or tissues.

The content of TFA material is not certified for implants. TFA materials are not designed or manufactured for use in implantation in the human body or in contact with internal body fluids or tissues. TFA has not performed clinical testing of these materials for implantation. TFA will not provide to customers making implantable devices any notice concerning its materials, as specified under 21 C.F.R. section 820.81, or any other information necessary for medical device use of the materials under any other statute or FDA regulation. TFA has neither sought, nor received, approval from the FDA for the use of these materials in implantation in the human body or in contact with internal body fluids or tissues.

Do not make reference to the TFA name or any TFA trademark in association with an implantable medical device. Do not use a TFA trademark as the descriptive name of an implantable medical device (e.g., do not call it the "TEFLON® prosthesis").

All implantable medical devices carry a risk of failure and adverse consequences. Regarding implantation of materials, you should rely upon the medical judgment of the physician, the medical device seller, and the FDA. Do not rely upon TFA. Examples of both harmful consequences and lifesaving benefits from the implantation of various materials can be found in published medical articles. Without performing clinical medical studies of an implantable medical device, TFA cannot weigh the benefits against the risks of that device and cannot offer a medical judgment on the safety or efficacy of the use of our material in that device.

Provide adequate ventilation during processing of TEFLON® fluoropolymer fibers. At elevated processing temperatures TEFLON® fluoropolymer fibers liberate vapors that may be harmful. Generally, adequate ventilation and care to avoid breathing vapors from heated TEFLON® will provide ample safety. Precautions for Handling and Use IMPORTANT: At temperatures above 400°F (204°C), TEFLON® PTFE fluoropolymer releases vapors that may be harmful. Good ventilation provides ample protection against an undesir­able concentration of these vapors (see Table). Table VI Recommended Ventilation for TEFLON® fluoropolymer fibers. At elevated Temperatures** Temperature Recommended Air Flow** ºF (ºC) ft3/min. lb of PTFE Resin (dm3/s/ kg of PTFE Resin) 500 (260) 1.3 (1.3) 550 (288) 3.6 (3.6) 600 (316) 10 (10) 650 (343) 33 (34) 700 (371) 73 (76) 750 (399) 180 (187) **See "Precautions for Handling and Use" ***Volume of air required to reduce gaseous products to levels found safe through many years of experience in processing TEFLON resins. Particular care should be taken to avoid contami­nating smoking tobacco with TEFLON®. Unusually heavy concentrations of harmful vapors could be inhaled when smoking contami­nated tobacco. Additional information concern­ing the safe handling and processing of TEFLON® PTFE fluoropolymer fiber is contained in the TFA Material Safety Data Sheet (MSDS) for these products, available upon request. More details of pyrolysis and hygienic studies are contained in the brochure, "TEFLON® Fluoropolymer Resins-Safety in Handling and Use," available upon request from DuPont Polymers.   Care should be exercised not to contaminate smoking tobaccos with TEFLON® fluoropolymer fibers. A mixture of pipe or cigarette tobacco and TEFLON® would be particularly bad if it were smoked because all the products of combustion from TEFLON® could be directly inhaled. This can be avoided by not carrying cigarettes or tobacco into areas where they might become contaminated. For more information, see TFA Technical Information Bulletins.

II faut ventiler suffisamment durant Ie travail des fibres fluoropolymerees "TEFLON." Lors du traitement a temperatures elevees, les fibres fluoropolymerees TEFLON® degagent des vapeurs qui peuvent etre nocives. En general, une ventilation suffisante et la precaution de ne pas inhaler directement les vapeurs de TEFLON® chauffe garantissent une securite suffisante.   II faut avoir soin de ne pas contaminer du tabac a pipe au des cigarettes avec des fibres fluoropolymerees TEFLON®. Fumer un melange de tabac a pipe au cigarettes et de TEFLON® est particulierement dangereux car tous les produits de combustion du TEFLON® pourraient etre directement inhales. Ceci peut etre evite en n'introduisant pas de cigarettes au de tabac dans les endroits ou ils risquent d'etre contamines.   Pour plus amples informations, consulter les Bulletins Techniques du TFA.

Beim Verarbeiten van TEFLON® Fluorkohlenwasserstoff-Fasern ist eine ausreichende Entluttung erforderlich. Bei erhohten Verarbeitungstemperaturen geben TEFLON® Fluorkohlenwasserstoff-­Fasern Dampfe ab, die gesundheitsschadlich sein konnen. Um das Einatmen van erhitztem TEFLON® Dampfe zu vermeiden, bieten erfahrungsgemass eine gute Entluftung sowie sorgfaltiges Handhaben genugend Sicherheit. Es muss darauf geachtet werden, dass Tabak nicht mit TEFLON® Fasern verunreinigt wird. Eine solche Mischung (Pfeifen-oder Zigarettentabak und TEFLON®) zu rauchen ware besonders gefahrlich, weil alle Verbrennungsruckstande des TEFLON® direkt eingeatmet werden. Dies kann verhUtef werden, wenn Zigaretten oderTabak nicht in Raume gebracht werden, wo sie verunreinigt werden konnten.   Weitere Einzelheiten sind im Technischen Merkblatt der Fasern-Abteilung enthalten.   TORAY Fluorofibers ( America), Inc.