1.1 This specification describes the physical, chemical, and mechanical performance requirements for polytetrafluoroethylene (PTFE) pre-fabricated by compression molding or extrusion into sheet, tube, and rod shapes which may be used for implant products. 1.2 PTFE is a high molecular weight straight chain member of the generic class of perfluorocarbon (containing only the elements fluorine and carbon) polymers. 1.3 Perfluorocarbon high polymers exhibit extraordinary thermal and chemical stability and do not require stabilizing additives of any kind. 1.4 This specification applies to primarily void-free molded or extruded PTFE shapes formed from granular molding powders. This specification does not apply to shapes formed from "fine powder" resins by lubricated paste extrusion, which includes expanded PTFE. 1.5 This specification does not apply to specific surgical implant products, including their packaging, sterilization, or material boicompatibility and/or suitability for a particular end-use application.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Appendix X2.2 is in conflict with an existing published final guidance, see section III. C. bullet 2 of the guidance listed below.