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ASTM F754-00

Historical Revision

Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

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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.


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.


SDO ASTM: ASTM International
Document Number F754
Publication Date May 10, 2000
Language en - English
Page Count 4
Revision Level 00
Supercedes
Committee F04.11
Publish Date Document Id Type View
Sept. 15, 2024 F0754-24 Revision
Oct. 1, 2008 F0754-08 Revision
May 10, 2000 F0754-00 Revision
March 1, 2015 F0754-08R15 Reaffirmation