Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
NORMA vydaná dňa 1.3.2015
Označenie normy: ASTM F754-08(2015)
Dátum vydania normy: 1.3.2015
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy 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)