ASTM-F754 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders (Withdrawn 2024)

ASTM-F754 - 2008 R15 EDITION - SUPERSEDED
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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.

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.

Significance and Use

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

3.1.1 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.

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

Keywords

perfluorocarbon; polytetrafluoroethylene; PTFE; surgical implant;

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F754-08(2015)

Revision Level

2008 R15 EDITION

Status

Superseded

Modification Type

Withdrawn

Publication Date

May 15, 2015

Document Type

Specification

Page Count

4 pages

Committee Number

F04.11