This specification describes the physical and chemical property, biocompatibility, and sterility requirements for polytetrafluoroethylene (PTFE) polymers fabricated in sheet, tube, and rod shapes that may be used for surgical implants. It ensures the absence of adulterants, additives, processing aids, or extractable organic contaminants from fabricated configurations. It does not apply to specific surgical implants, would instead be subjected to appropriate end-use performance standards.

1.1 This specification describes the performance of polytetrafluoroethylene (PTFE) fabricated in sheet, tube, and rod shapes which may be used for surgical implants. PTFE is a member of the generic class of perfluorocarbon (containing only the elements fluorine and carbon) polymers.

1.2 Perfluorocarbon high polymers are solids exhibiting extraordinary thermal and chemical stability. They do not require stabilizing additives of any kind.

1.3 The biological response to PTFE in soft tissue and bone has been well characterized by a history of clinical use and animal studies (1-9).

1.4 This specification does not apply to specific surgical implants. Such implants would be subject to appropriate end-use performance standards.