ASTM F754

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.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

Significance and Use

Fabricated PTFE meeting the requirements of this specification can be expected to exhibit consistent and reproducible chemical, physical, and biological properties.

This specification provides an analytic method to extract organic contaminants from fabricated configurations, which includes a limit to the presence of residual adulterants, additives, or processing aids.

This specification addresses the characteristics of virgin raw granular molding powders obtained from resin manufacturers and used for producing implant configurations.

1. 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.

2. Referenced Documents

D1457 Specification for PTFE Molding and Extrusion Materials
D1710 Specification for Polytetrafluoroethylene (PTFE) Basic Shapes, Rod, and Heavy-Walled Tubing
D1898 Practice for Sampling of Plastics
D3293 Specification for PTFE Resin Molded Sheet
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
F750 Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxity
F981 Practice for Assessment of Compatibility of Biomaterials (Non-porous) for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

Index Terms

perfluorocarbon; polytetrafluoroethylene; PTFE; surgical implant; Implantable surgical materials/applications; Plastic surgical devices/applications--specifications; Polymers--surgical applications (specifications); PTFE (polytetrafluoroethylene)--surgical implant specifications; Surgical implants--specifications ; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Citing ASTM Standards

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