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  • ASTM
    F754-08(2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
    Edition: 2015
    $68.64
    Unlimited Users per year

Description of ASTM-F754 2015

ASTM F754-08-Reapproved2015

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




ASTM F754

Scope

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.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


Keywords

perfluorocarbon; polytetrafluoroethylene; PTFE; surgical implant;


ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)


DOI: 10.1520/F0754-08R15

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