ASTM F754-00
(Specification)Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes
Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes
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.
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.
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Designation: F 754 – 00
Standard Specification for
Implantable Polytetrafluoroethylene (PTFE) Polymer
Fabricated in Sheet, Tube, and Rod Shapes
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope ods for Materials and Devices
F 749 Practice for Evaluating Material Extracts by Intracu-
1.1 This specification describes the performance of poly-
taneous Injection in the Rabbit
tetrafluoroethylene (PTFE) fabricated in sheet, tube, and rod
F 750 PracticeforEvaluatingMaterialExtractsbySystemic
shapes which may be used for surgical implants. PTFE is a
Injection in the Mouse
member of the generic class of perfluorocarbon (containing
F 813 PracticeforDirectContactCellCultureEvaluationof
only the elements fluorine and carbon) polymers.
Materials for Medical Devices
1.2 Perfluorocarbon high polymers are solids exhibiting
F 895 Test Method forAgar Diffusion Cell Culture Screen-
extraordinary thermal and chemical stability. They do not
ing for Cytotoxity
require stabilizing additives of any kind.
F 981 Practice for Assessment of Compatibility of Bioma-
1.3 The biological response to PTFE in soft tissue and bone
terials (Non-porous) for Surgical Implants with Respect to
has been well characterized by a history of clinical use and
Effect of Materials on Muscle and Bone
animal studies (1-9).
1.4 This specification does not apply to specific surgical
3. Significance and Use
implants. Such implants would be subject to appropriate
3.1 FabricatedPTFEmeetingtherequirementsofthisspeci-
end-use performance standards.
fication will exhibit consistent and reproducible chemical,
1.5 This standard does not purport to address all of the
physical, and biological properties.
safety concerns, if any, associated with its use. It is the
3.1.1 This specification ensures the absence of adulterants,
responsibility of the user of this standard to establish appro-
additives, or processing aids.
priate safety and health practices and determine the applica-
3.1.2 This specification ensures the absence of extractable
bility of regulatory limitations prior to use.
organic contaminants from fabricated configurations.
2. Referenced Documents 3.1.3 Fabricated configurations satisfying this specification
should be compatible with tissue.
2.1 ASTM Standards:
3.1.4 This specification addresses the characteristics of
D 1457 Specification for PTFE Molding and Extrusion
virginrawmoldingpowdersobtainedfromresinmanufacturers
Materials
and used for producing implant configurations and of configu-
D 1710 Specification for Polytetrafluoroethylene (PTFE)
rations packaged in either nonsterile or sterile states.
Basic Shapes, Rod, and Heavy–Walled Tubing
4 3.2 PTFE configurations were first used for implantation in
D 1898 Practice for Sampling of Plastics
the early 1950’s and have served as compatible implants in
D 3293 Specification for PTFE Resin Molded Sheet
large numbers of patients since that time with some implant
F 748 Practice for Selecting Generic Biological Test Meth-
durations beyond 20 years (1). Reports of reaction to particu-
late debris of PTFE in load bearing applications outside of the
pressure-velocity (PV) limits for the polymer (10, 11) have not
ThisspecificationisunderthejurisdictionofASTMCommitteeF-4onMedical
been correlated with other biocompatibility assays for this
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
polymer and clinical experience with molding powders or
F04.16 on Biocompatibility.
intact implants of this polymer (1, 12). The shape and size of
Current edition approved May 10, 2000. Published August 2000. Originally
published as F 754 – 83. Last previous edition F 754 – 88 (95).
wear particles of this polymer and other implanted high
The boldface numbers in parentheses refer to the list of references at the end of
polymers have been suggested as factors in elicited tissue
this specification.
Annual Book of ASTM Standards, Vol 08.01.
Annual Book of ASTM Standards, Vol 08.02.
5 6
Annual Book of ASTM Standards, Vol 08.03. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F754–00
reaction (1, 11, 13). Therefore, care should be exercised not to 5.2 Extraction with Distilled Water—PTFE sampled from
construe this specification for applications where particulate packaged-for-sale stock shall be extracted with distilled water
debris may be anticipated. by the methodology described in Annex A2.
5.2.1 Extractable Electrolytes—The resistivity of the water
4. Physical Property Requirements
as measured by a resistivity conductivity meter shall be greater
4.1 Molding and Extrusion Powders:
than 0.05 MV·cm.
4.1.1 PTFE Polymer— Molding and extrusion powders 5.2.2 Appearance—When examined by unaided vision in
used for fabrication of implant configurations shall be virgin
daylight, the appearance of PTFE sampled from stock imme-
product which conform to Specification D 1457. diately following water extraction shall be unchanged except
4.2 PTFE Standard Shapes:
for being obviously wet with water. When dried for 4 h at
4.2.1 Standard shapes such as molded sheet, rod, or tube 100°C in an air-circulating oven the appearance shall be
shall have been prepared from virgin molding or extrusion
unchanged from pre-extraction appearance.
materials which meet Specification D 1457.
4.2.2 PTFEmoldedsheetshallcomplywithTypeI,GradeI,
6. Biocompatibility
Class A requirements in Specification D 3293.
6.1 Extractables Under Simulated and Accelerated In Vivo
4.2.3 PTFE rod and tube shall comply with Type I, Grade I,
Exposure—The polymer sampled from packaged-for-sale
Class D specifications in Specification D 1710. Material pur-
stock shall be tested under the general methodology and
chased for conversion into final implant shapes may meet
Practices F 749 and F 750 with specific conditions and criteria
Classes A, B, C, or D by vendor and vendee agreement.
described in Annex A3.
4.3 Surface Contamination—The surface of a fabricated
6.2 Acute Biocompatibility Requirements—The polymer
shape shall not contain particles of residue of diameter greater
sampled from packaged-for-sale stock shall show no cyto-
than 300 µm. The concentration of visible particles under 83
pathiceffectwhenevaluatedbyatissueculturetestusingdirect
magnification shall not be greater than 10 particles per 400
contact of specimen with cell layer technique (13, 14) or
cm .
ASTM Practice F 813 and Test Method F 895.
4.4 Physical properties for other than standard shapes are
6.3 Chronic Biocompatibility Requirements—Vendor and
not encompassed by this specification and must be addressed
vendee agreement may utilize the large, long-term and benign
by appropriate performance standards for given configurations.
animal and clinical history of this generic class of polymer as
equivalent to Practice F 748 and Practice F 981 certification.
5. Chemical Property Requirements
5.1 Carbon Tetrachloride Extraction—PTFE sampled in
7. Sterility
accordance with Practice D 1898, from packaged-for-sale
7.1 Fabricated configurations of PTFE are thermally stable
stock shall be extracted with carbon tetrachloride by the
to indefinite exposure at 200°C. The fabricated polymer shall,
method described in Annex A1.
after sterilization, pass the USP Sterility Test (15). Therefore,
5.1.1 Extractable Hydrocarbons—The absence of extract-
primary or repetitive sterilization by reliable steam autoclave
able hydrocarbons shall be demonstrated by infrared analysis
techniqueissuggested.Analternativesterilizationtechniqueof
of the carbon tetrachloride extract using the methodology and
using ethylene oxide may be adopted with due consideration
acceptance criteria described in Annex A1.
for degassing rates for the particular specimen configuration.
5.1.2 Appearance—A sample should be obtained from
Sterilizationbyirradiationmaycausemoleculardegradationof
packaged-for-sale stock and examined under daylight condi-
the polymer above certain radiation levels. Depending on the
tions with the naked eye immediately following carbon tetra-
intended use of the implant, this molecular degradation could
chloride extraction as described in Annex A1. This sample
affect its mechanical and biocompatible properties.
whilestillwetwithcarbontetrachlorideshallnotbeapparently
changed in size or consistency. When dried for4hina 100°C
8. Keywords
air-circulating oven, the appearance of the extracted polymer
sample shall be unchanged as compared to an unextracted 8.1 high polymer; polymer; polytetrafluoroethylene; PTFE;
specimen. surgical implant
F754–00
ANNEXES
(Mandatory Information)
A1. INFRARED ANALYSIS OF HYDROCARBONS EXTRACTABLE IN CARBON TETRACHLORIDE
A1.1 Stiratleast1gofchoppedsample,allofwhichpasses A1.2.1 The requirements of this analysis shall be satisfied
a No. 40 mesh screen, for 30 min with 7-mL of reagent-grade whentransmissionbetween3and4µmisessentially100 %for
carbon tetrachloride. When decanted, the carbon tetrachloride
the reagent grade control and at least 95% of that of the control
shall be clear and colorless.
scan for carbon tetrachloride in which the chopped sample was
stored.
A1.2 Perform infrared analysis with a Beckman Infrared
Spectrophotometer IR-8, with Beckman Cell Part No. 580012,
or equivalent.
A2. EXTRACTION WITH WATER FOR ELECTROLYTE
...
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