ASTM F754-08(2015)
(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
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.
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.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F754 −08 (Reapproved 2015)
Standard Specification for
Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and
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.
This standard has been approved for use by agencies of the U.S. Department of Defense.
1. Scope priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This specification describes the physical, chemical, and
mechanical performance requirements for polytetrafluoroeth-
2. Referenced Documents
ylene(PTFE)pre-fabricatedbycompressionmoldingorextru-
2.1 ASTM Standards:
sion into sheet, tube, and rod shapes which may be used for
D1710Specification for Extruded Polytetrafluoroethylene
implant products.
(PTFE) Rod, Heavy Walled Tubing and Basic Shapes
1.2 PTFE is a high molecular weight straight chain member
D3294 Specification for Polytetrafluoroethylene (PTFE)
of the generic class of perfluorocarbon (containing only the
Resin Molded Sheet and Molded Basic Shapes
elements fluorine and carbon) polymers.
D4894 Specification for Polytetrafluoroethylene (PTFE)
1.3 Perfluorocarbon high polymers exhibit extraordinary
Granular Molding and Ram Extrusion Materials
thermal and chemical stability and do not require stabilizing
E1994Practice for Use of Process Oriented AOQL and
additives of any kind.
LTPD Sampling Plans
2.2 AAMI Standards:
1.4 This specification applies to primarily void-free molded
AAMI STBK9–1 Sterilization—Part 1: Sterilization in
or extruded PTFE shapes formed from granular molding
Health Care Facilities
powders. This specification does not apply to shapes formed
AAMI STBK9–2Sterilization—Part 2: Sterilization Equip-
from“finepowder”resinsbylubricatedpasteextrusion,which
ment
includes expanded PTFE.
AAMI STBK9–3Sterilization—Part 3: Industrial Process
1.5 This specification does not apply to specific surgical
Control
implant products, including their packaging, sterilization, or
2.3 ANSI Standards:
material boicompatibility and/or suitability for a particular
ANSI/ISO/ASQ Q9000Quality Management Systems—
end-use application.
Fundamentals and Vocabulary
1.6 The values stated in SI units are to be regarded as
ANSI/ISO/ASQ Q9001Quality Management Systems—
standard. No other units of measurement are included in this
Requirements
standard. 4
2.4 ISO Standards:
1.7 This standard does not purport to address all of the
ISO 10993Biological Evaluation of Medical Devices
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
This specification is under the jurisdiction of ASTM Committee F04 on Standards volume information, refer to the standard’s Document Summary page on
Medical and Surgical Materials and Devices and is the direct responsibility of the ASTM website.
Subcommittee F04.11 on Polymeric Materials. Available from Association for the Advancement of Medical Instrumentation
Current edition approved March 1, 2015. Published May 2015. Originally (AAMI), 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201–4795.
approved in 1983. Last previous edition approved in 2008 as F754–08. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0754-08R15. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F754 − 08 (2015)
2.5 U. S. Code of Federal Regulations: 5. Chemical Property Requirements
21 CFR 820Quality System Regulation
5.1 Carbon Tetrachloride Extraction—The supplier-
2.6 U. S. Pharmacopeia (USP) Standards: provided or as-converted final PTFE implant shapes shall be
USP30/NF25 <1211>Sterilization and Sterility Assurance sampled in accordance with Practice E1994 (or equivalent
of Compendial Articles standard guidance) and extracted with carbon tetrachloride by
the method described in Annex A1.
3. Significance and Use 5.1.1 Extractable Hydrocarbons—The absence of extract-
able hydrocarbons shall be demonstrated by infrared analysis
3.1 FabricatedPTFEmeetingtherequirementsofthisspeci-
of the carbon tetrachloride extract using the methodology and
fication can be expected to exhibit consistent and reproducible
acceptance criteria described in Annex A1.
chemical, physical, and biological properties.
5.1.2 Appearance—Asample shall be examined under day-
3.1.1 This specification provides an analytic method to
light conditions with the naked eye immediately following
extract organic contaminants from fabricated configurations,
carbon tetrachloride extraction as described in AnnexA1.This
which includes a limit to the presence of residual adulterants,
sample while still wet with carbon tetrachloride shall not be
additives, or processing aids.
apparently changed in size or consistency. When dried for 4 h
3.1.2 This specification addresses the characteristics of
ina100°Cair-circulatingoven,theappearanceoftheextracted
virgin raw granular molding powders obtained from resin
polymer sample shall be unchanged as compared to an unex-
manufacturers and used for producing implant configurations.
tracted specimen.
4. Physical Property Requirements 5.2 Extraction with Distilled Water—Final PTFE implant
shapes sampled from stock shall be extracted with distilled
4.1 Molding and Extrusion Powders:
water by the methodology described in Annex A2.
4.1.1 PTFE Polymer—Granular molding and extrusion
5.2.1 Extractable Electrolytes—The resistivity of the water
powdersusedforfabricationofimplantconfigurationsshallbe
asmeasuredbyaresistivityconductivitymetershallbegreater
virgin product and shall conform to Specification D4894.
than 0.05 MΩ·cm.
4.2 PTFE Standard Shapes:
5.2.2 Appearance—When examined by unaided vision in
4.2.1 Standard shapes, such as molded sheet, rod, and/or
daylight, the appearance of PTFE sampled from stock imme-
tube utilized in implants, shall have been prepared from virgin
diately following water extraction shall be unchanged except
molding or extrusion materials which meet the provisions of
for being obviously wet with water. When dried for 4 h at
4.1.1.
100°C in an air-circulating oven the appearance shall be
4.2.2 PTFEmoldedsheetshallcomplywithTypeI,GradeI,
unchanged from pre-extraction appearance.
Class A requirements in Specification D3294.
6. Manufacturing Control, Sterilization, and
4.2.3 PTFE rod and/or tube in the final implant shape shall
Biocompatibility
comply with Type I, Grade I, Class D specifications in
Specification D1710. Material purchased for conversion into a
6.1 Any final implant product needs to be manufactured
final implant shape may meet Classes A, B, C, or D. under an acceptable level of control and provided both in
4.2.4 The final implant manufacturer shall determine if the
sterileformandwithalevelofbiocompatibilitysuitableforthe
specified dimensions and mechanical properties of the
final implant application.
supplier-provided and/or as-converted sheet, rod, and/or tube
6.2 Acceptable levels of manufacturing control are likely to
areappropriatefortheintendedimplantapplication.Additional
berequiredforcommercialdistribution.Generalguidelinesfor
material property data (such as fatigue life, wear, and abrasion
achieving acceptable levels of manufacturing quality control
resistance) may also be necessary to assure suitability, depen-
may be found in the following standards:
dent on the implant application.
6.2.1 United States Code of Federal Regulations (CFR), 21
4.3 Surface Contamination—The surface of a fabricated CFR 820.
shape shall not contain particles or residue of a diameter 6.2.2 ANSI/ISO/ASQ Q9000—Provides fundamentals for
greater than 300 µm. The concentration of visible particles quality management systems as described in the ISO 9000
under 8× magnification shall not be greater than 10 particles family (informative); and specifies quality management terms
per 400 cm . and their definitions (normative).
6.2.3 ANSI/ISO/ASQ Q9001—Presents requirements for a
4.4 Physical properties for other than standard shapes are
quality management system. The application of this guide can
not encompassed by this specification and must be addressed
beusedbyanorganizationtodemonstrateitscapabilitytomeet
byappropriateperformances
...
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