Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
STANDARD published on 15.9.2024
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Designation standards: ASTM F754-24
Publication date standards: 15.9.2024
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM
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.
Keywords:
perfluorocarbon, polytetrafluoroethylene, PTFE, surgical implant,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)