ASTM F754-08
(Specification)Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
ABSTRACT
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.
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.
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.
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Designation:F754 −08
StandardSpecification for
Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and
1
Rod Shapes Fabricated from Granular Molding Powders
ThisstandardisissuedunderthefixeddesignationF754;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This specification describes the physical, chemical, and 2.1 ASTM Standards:
mechanical performance requirements for polytetrafluoroeth- D1710Specification for Extruded Polytetrafluoroethylene
ylene(PTFE)pre-fabricatedbycompressionmoldingorextru- (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
sion into sheet, tube, and rod shapes which may be used for D3294 Specification for Polytetrafluoroethylene (PTFE)
implant products. Resin Molded Sheet and Molded Basic Shapes
D4894 Specification for Polytetrafluoroethylene (PTFE)
1.2 PTFE is a high molecular weight straight chain member
Granular Molding and Ram Extrusion Materials
of the generic class of perfluorocarbon (containing only the
E1994Practice for Use of Process Oriented AOQL and
elements fluorine and carbon) polymers.
LTPD Sampling Plans
1.3 Perfluorocarbon high polymers exhibit extraordinary
3
2.2 AAMI Standards:
thermal and chemical stability and do not require stabilizing
AAMI STBK9–1 Sterilization—Part 1: Sterilization in
additives of any kind.
Health Care Facilities
1.4 This specification applies to primarily void-free molded
AAMI STBK9–2Sterilization—Part 2: Sterilization Equip-
or extruded PTFE shapes formed from granular molding
ment
powders. This specification does not apply to shapes formed
AAMI STBK9–3Sterilization—Part 3: Industrial Process
from“finepowder”resinsbylubricatedpasteextrusion,which
Control
4
includes expanded PTFE.
2.3 ANSI Standards:
ANSI/ISO/ASQ Q9000Quality Management Systems—
1.5 This specification does not apply to specific surgical
Fundamentals and Vocabulary
implant products, including their packaging, sterilization, or
ANSI/ISO/ASQ Q9001Quality Management Systems—
material boicompatibility and/or suitability for a particular
Requirements
end-use application.
4
2.4 ISO Standards:
1.6 The values stated in SI units are to be regarded as
ISO 10993Biological Evaluation of Medical Devices
standard. No other units of measurement are included in this
5
2.5 U. S. Code of Federal Regulations:
standard.
21 CFR 820Quality System Regulation
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 appro-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
priate safety and health practices and determine the applica-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
bility of regulatory limitations prior to use. Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from Association for the Advancement of Medical Instrumentation
1
This specification is under the jurisdiction of ASTM Committee F04 on (AAMI), 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201–4795.
4
Medical and Surgical Materials and Devicesand is the direct responsibility of Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Subcommittee F04.11 on Polymeric Materials. 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Current edition approved Oct. 1, 2008. Published November 2008. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
approved in 1983. Last previous edition approved in 2000 as F754–00. DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F0754-08. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F754−08
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2.6 U. S. Pharmacopeia (USP) Standards: standard guidance) and extracted with carbon tetrachloride by
USP30/NF25 <1211>Sterilization and Sterility Assurance the method described in Annex A1.
of Compendial Articles
5.1.1 Extractable Hydrocarbons—The absence of extract-
able hydrocarbons shall be demonstrated by infrared analysis
3. Significance and Use
of the carbon tetrachloride extract using the methodology and
acceptance criteria described in Annex A1.
3.1 FabricatedPTFEmeetingtherequirementsofthisspeci-
fication can be expected to exhibit consistent and reproducible 5.1.2 Appearance—Asample shall be examined under day-
light conditions with the naked eye immediately following
chemical, physical, and biological properties.
3.1.1 This specification provides an analyti
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F754–00 Designation: F 754 – 08
Standard Specification for
Implantable Polytetrafluoroethylene (PTFE) Polymer
Fabricated in Sheet, Tube, and Rod Shapes Implantable
Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod
1
Shapes Fabricated from Granular Molding Powders
This standard is issued under the fixed designation F 754; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification describes the performance of polytetrafluoroethylene (PTFE) fabricated in sheet, tube, and rod shapes
which may be used for surgical implants. PTFE is a member of the generic class of perfluorocarbon (containing only the elements
fluorine and carbon) polymers.
1.2 Perfluorocarbon high polymers are solids exhibiting extraordinary thermal and chemical stability. They do not require
stabilizing additives of any kind.
1.3 The biological response to PTFE in soft tissue and bone has been well characterized by a history of clinical use and animal
studies (1-9).
1.4 This specification does not apply to specific surgical implants. Such implants would be subject to appropriate end-use
performance standards.
1.5
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
2
2.1 ASTM Standards:D1457Specification for PTFE Molding and Extrusion Materials
D 1710Specification for Polytetrafluoroethylene (PTFE) Basic Shapes, Rod, and Heavy–Walled Tubing
4
D1898PracticeforSamplingofPlastics SpecificationforExtrudedPolytetrafluoroethylene(PTFE)Rod,HeavyWalledTubing
and Basic Shapes
1
This specification is under the jurisdiction of ASTM Committee F-4 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility.
Current edition approved May 10, 2000. Published August 2000. Originally published as F754–83. Last previous edition F754–88 (95).
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Oct. 1, 2008. Published November 2008. Originally approved in 1983. Last previous edition approved in 2000 as F 754 – 00.
2
The boldface numbers in parentheses refer to the list of references at the end of this specification.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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F754–08
D3293Specification for PTFE Resin Molded Sheet 3294 Specification for Polytetrafluoroethylene (PTFE) Resin Molded Sheet
and Molded Basic Shapes
F748Practice for Selecting Generic Biological Test Methods for Materials and DevicesD 4894 Specificati
...
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