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Designation: F 754 - 88
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 lasf revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (c) indicates an ediforial change since the last revision or reapproval.
1. Scope
1.1 This specification describes the performance of poly-
tetrafluoroethylene (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 (i-9).2
1.4 This specification does not apply to specific surgical
implants. Such implants would be subject to appropriate
end-use performance standards.
2. Referenced Documents
2.1 ASTM Standards:
D 1457 Specification for PTFE Molding and Extrusion
Materials3
D 17 10 Specification for TE-Fluorocarbon Rod4
D 1898 Practice for Sampling of Plastics4
D 3293 Specification for PTFE Resin Molded Sheet'
F 748 Practice for Selecting Generic Biological Test
Methods for Materials and Devices6
F 749 Practice for Evaluating Material Extracts by Intra-
cutaneous Injection in the Rabbit6
F 750 Practice for Evaluating Material Extracts by Sys-
temic Injection in the Mouse6
F 8 13 Practice for Direct Contact Cell Culture Evaluation
of Materials for Medical Devices6
F 895 Test Method for Agar Diffusion Cell Culture
Screening for Cytotoxity6
F 981 Practice for Assessment of Compatibility of Bio-
materials (Nonporous) for Surgical Implants with Re-
spect to Effect of Materials on Muscle and Bone6
3. Significance and Use
3.1-Fabricated PTFE meeting the requirements of this
I This specification is under the juridiction of ASTM Committee ~ - on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.02 on Resources.
Current edition approved April 29, 1988. Published June 1988. Originally
published as F 754 - 83. Last previous edition F 754 - 83.
The boldface numbers in parentheses refer to the list of references at the end
of this specification.
' Annital Book of ASTM Siandards, Vol 08.0 I.
Annital Book of ASTM Standards, Vol 08.02.
Aniiiial Book of ASTM Standards, Vol 08.03.
Annital Book of ASTM Standards, Vol 13.01.
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1916 Race Ct.; Philadelphia, Pa. 19103
Reprinted from lha Annual Book of ASTM Standards. Copyright ASTM
If not listed in the current combined index, will appear in the naxt edition.
specification will exhibit consistent and reproducible chem-
ical, physical, and biological properties.
3.1.1 This specification ensures the absence of adulter-
ants, additives, or processing aids.
3.1.2 This specification ensures the absence of extractable
organic contaminants from fabricated configurations.
3.1.3 Fabricated configurations satisfying this specifica-
tion should be compatible with tissue.
3.1.4 This specification addresses the characteristics of
virgin raw molding powders obtained from resin manufac-
turers and used for producing implant configurations and of
configurations packaged in either nonsterile or sterile states.
3.2 PTFE configurations were first used for implantation
in the early 1950's and have served as compatible implants in
large numbers of patients since that time with some implant
durations beyond 20 years (1). Reports of reaction to
particulate debris of PTFE in load bearing applications
outside of the pressure-velocity (PV) limits for the polymer
( 1 0 , l l ) have not been correlated with other biocompatibility
assays for this polymer and clinical experience with molding
powders or intact implants of this polymer (1,12). The shape
and size of wear particles of this polymer and other im-
planted high polymers have been suggested as factors in
elicited tissue reaction (1, 11, 13). Therefore, care should be
exercised not to construe this specification for applications
where particulate debris may be anticipated.
4. Physical Property Requirements
4.1 Molding and Extrusion Powders:
4.1.1 PTFE Polymer-Molding and extrusion powders
used for fabrication of implant configurations shall be virgin
product which conform to Specification D 1457.
4.2 PTFE Standard Shapes:
4.2.1 Standard shapes such as molded sheet, rod, or tube
shall have been prepared from virgin molding or extrusion
materials which meet Specification D 1457.
4.2.2 PTFE molded sheet shall comply with Type I, Grade
I, Class A requirements in specification D 32931 ~
4.2.3 PTFE rod and tube shall comulv with Tvue I, Grade
I, Class D specifications in Specific&& D 17iÔ. Material
4 purchased for conversion into final implant shapes may meet
Classes A, B, C, or D by vendor and vendee agreement.
4.3 Surface Contamination-The surface of a fabricated
shape shall not contain particles of residue of diameter
greater than 300 Um. The Concentration O f visible Darticles
under 8X magnification shail not be greater than 10 particles
per 400 cm2.
4.4 Physical properties for other than standard shapes are
not encompassed by this specification and must be addressed
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 A S T M F75Y 88
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by appropriate performance standards for given configura-
tions.
5. Chemical Property Requirements
5.1 Carbon Tetrachloride Extraction-PTFE sampled in
accordance with Practice D 1898, from packaged-for-sale
stock shall be extracted with carbon tetrachloride by the
method described in Annex A I.
5.1.1 Extractable Hydrocarbons-The absence of extract-
able hydrocarbons shall be demonstrated by infrared analysis
of the carbon tetrachloride extract using the methodology
and acceptance criteria described in Annex Al.
5.1.2 Appeurance-A sample should be obtained from
packaged-for-sale stock and examined under daylight condi-
tions with the naked eye immediately following carbon
tetrachloride extraction as described in Annex Al. This
sample while still wet with carbon tetrachloride shall not be
apparently changed in size or consistency. When dried for 4
h in a 100°C air-circulating oven, the appearance of the
extracted polymer sample shall be unchanged as compared
to an unextracted specimen.
5.2 Extraction with Distilled Water-PTFE sampled from
packaged-for-sale stock shall be extracted with distilled water
by the methodology described in Annex A2.
5.2.1 Extractable Electrolytes-The resistivity of the water
as measured by a resistivity conductivity meter shall be
greater than 0.05 MQ-cm.
5.2.2 Appearance-When examined by unaided vision in
daylight, the appearance of PTFE sampled from stock
immediately following water extraction shall be unchanged
except for being obviously wet with water. When dried for 4
h at 100°C in an air-circulating oven the appearance shall be
(Mandatory Information)
Al. INFRARED ANALYSIS OF HYDROCARBONS EXTRACTABLE IN CARBON TETRACHLORIDE
A1.1 Stir at least 1 g of chopped sample, all of which passes
a No. 40 mesh screen, for 30 min with 7-mL of reagent-grade
carbon tetrachloride. When decanted, the carbon tetrachlo-
ride shall be clear and colorless.
A1.2 Perform infrared analysis with a Beckman Infrared
Spectrophotometer IR-8, with Beckman Cell Part No.
A2. EXTRACTION WITH WATER FOR ELECTROLYTES
A2.1 The specimens shall be cubes or rectangles with no
edge dimension greater than 1 cm. The total specimen
weight shall be 10 f 1 g.
A2.2 Place the specimens in a suitable container, such as a
100-cm3suction flask, along with 50 mL of distilled water.
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unchanged from pre-extraction appearance.
6. Biocompatibility
6.1 Extractables Under Simulated and Accelerated In
Vivo Exposure-The polymer sampled from packaged-for-
sale stock shall be tested under the general methodology and
Practices F 749 and F 750 with specific conditions and
criteria described in Annex A3.
6.2 Acute Biocompatibility Requirements-The polymer
sampled from packaged-for-sale stock shall show no
cytopathic effect when evaluated by a tissue culture test using
direct contact of specimen with cell layer technique (13,14)
or ASTM Practice F 813 and Test Method F 895.
6.3 Chronic Biocompatibility Requirements-Vendor and
vendee agreement may utilize the large, long-term and
benign animal and clinical history of this generic class of
polymer as equivalent to Practice F 748 and Practice F 98 1
certification.
7. Sterility
7.1 Fabricated configurations of PTFE are thermally
stable to indefinite exposure at 200°C. The fabricated
polymer shall, after sterilization, pass the USP Sterility Test
(15). Therefore, primary or repetitive sterilization by reliable
steam autoclave technique is suggested. An alternative steril-
ization technique of using ethylene oxide may be adopted
with due consideration for degassing rates for the particular
specimen configuration. Sterilization by irradiation may
cause molecular degradation of the polymer above certain
radiation levels. Depending on the intended tise of the
implant, this molecular degradation could affect its mechan-
ical and biocompatible properties.
ANNEXES
580012, or equivalent.
A 1.2.1 The requirements of this analysis shall be satisfied
when transmission between 3 and 4 pm is essentially 100 %
for the reagent grade control and at least 95 % of that of the
control scan for carbon tetrachloride in which the chopped
sample was stored.
Store the flask 48 h at ambient temperature.
A2.3 After 48 h, decant the water. The water shall remain
clear and colorless. The extractable electrolyte requirements
shall be satisfied when the resistivity of the water is greater
than 0.05 MQ-cm.
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 A3. INFRARED ANALYSIS FOR ORGANIC SUBSTANCES EXTRACTABLE UNDER ACCELERATED,
SIMULATED IN VIVO CONDITIONS (4)
A3.1 Use a total sample size of i50 squares each mea-
suring l by 5 by 5 mm or a sample size having equivalent
volume and surface area.
A3.2 Extracting Media-Prepare pseudo-extracellular
fluid by dissolving 6.68 g of NaC1, 2.50 g of NaHCO,, O. 174
g of K2HP04, and 0.220 g of KCL in 1000 mL of distilled
water.
A3.3 Extraction Technique-Place the sample in a monel
metal screen cage and submerge in 250 mL of the extracting
media. Conditions of extraction shall be 66 h at 96°C.
A3.4 Infrared Analysis-After extraction is complete, de-
cant the pseudo-extracellular fluid. Its color shall be un-
changed from pre-extraction. Extract the decanted liquid
APPENDIX
(Nonmandatory Information)
X1. STATEMENT OF RATIONALE
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X1.l The intention of this standard is to provide a
performance specification by: (1) specification of raw mate-
rials; (2) specification of fabricated shape, physical, and
chemical properties; and (3) biocompatibility performance
specifications for finished product. In this way, end users
may be assured of safety and efficacy of such products in
permanent in vivo implantation applications. If intended
efficacy cannot be provided by simple sheet, tube, and rod
shapes as described in the specification, an additional per-
formance specification for other physical forms of this
polymer must be used in addition to this specification.
X 1.2 The scope section of this document defines the term
“PTFE” and limits the specific scope of the document to
fabricated sheet, tube, and rod shapes. It further makes clear
that the specification does not apply to specific surgical
implants that would be subject to appropriate specific
end-use performance standards. This section emphasizes the
extraordinary chemical and thermal stability and inherent
absence of additives in PTFE, these factors are no doubt
responsible for the large bibliography of successful implant
use for this polymer in the absence of any previous implant
grade specification guidance.
X1.3 The significance section sets out the capability of
this standard by ensuring consistent and reproducible be-
havior. Section 3.2 explains the caution against construing
this specification for applications where particulate debris
may be anticipated.
X1.4 In 4.1 the specific raw polymer properties consistent
with the scope and intent of this specification are defined in
terms of existing ASTM specifications so that the raw
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with 14 mL of reagent-grade carbon tetrachloride in a
separatory funnel. Separate the carbon tetrachloride and dry
with anhydrous MgS04. Compare a sample of the dried
extractant sample with fresh reagent-grade carbon tetrachlo-
ride using an infrared spectrophotometer (Beckman IR-8
spectrophotometeror equivalent, Beckman Part No. 5800 12
cell, or equivalent). If hydrocarbons are present infrared
absorption will occur between 3 and 4 pm.
A3.4.1 The requirements of this test shail be satisfied
when transmission between 3 and 4 pm is essentially 100 %
for reagent-grade carbon tetrachloride and at least 95 % of
that for that of the control scan for the carbon tetrachloride
extract.
polymers wiii be virgin products providing the highest purity
available under current manufacturing technology. Simi-
larly, 4.2 relates the finished shape physical properties
consistent with the scope and objectives of this standard
specification to existing ASTM specifications for such
standard shapes. These requirements would provide the
superior properties for such shapes available with current
fabrication technology.
X1.5 Section 5 provides appearance and extractable cri-
teria for PTFE-fabricated shapes sampled from packaged-
for-sale stock to establish the absence of extractable organic
or electrolytic contaminants that may have contaminated the
product during its preparation and packaging. These tests
would then signal the need for review of manufacturing
protocol to determine where a breach may have occurred of
the Good Manufacturing Practices regulations detailed in the
U.S. Code of Federal Regulations.
X1.6 Section 6 prescribes specific biocompatibility assays
that may be readily conducted on samples from packaged-
for-sale stock to ensure biocompatibility. Although ASTM
Practices F 749 and F 750 are the primary references for the
evaluation of extractables under accelerated simulated in
vivo exposure, more stringent test conditions are recom-
mended in Annex A3 which the unique chemical and
thermal stability and absence of additives of PTFE make
feasible. These more stringent test conditions have provided
assurance of safe and effective long-term in vivo implant
performance for fabricated PTFE (1, 12).
X1.7 Finally, in Section 7 factors relating to mode of
sterilization and reference to the USP sterility test protocols
are described.
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REFERENCES

(1) Homsy, C. A., “Biocompatibility of Perfluorinated Polymers and (8) Friedenberg, Z. B., “Bone Growth into Teflon Sponge,” Surgery,
Composites of These Polymers,” Bìocompatìbilìty of Clinical Gynecology, and Obstetrics, Vol 116, 1963, p. 588.
Implant Materials, O.F. Williams, ed., Chap. 3, Vol II, Boca (9) U.S.Food and Drug Administration, Minutes of Panel Hearings,
Raton, FL, C.R.C. Press, Inc., 1982, pp 59-77. General and Plastic Surgery Devices Classification Panel,
(2) Calnan, J., “The Use of Inert Plastic Material in Reconstructive Washington, D.C., March 24, 1978.
Surgery,” British Journal of Plastic Surgery, Vol 16, 1963, p. 1. (10) Charnley, J., “Factors in the Design of an Artificial Hip Joint,
(3) Homsy, C. A., and Anderson, M. S.,“Functional Stabilization of Lubrication and Wear in Living and Artificial Human Joints,”
Soft Tissue and Bone Prostheses with a Porous Low Modulus Proceedings of the Institute of Mechanical Engineers, Vol 18 1,
Materials System,” Biocompatibility of Implant Materials, 1966-1967, pp. 104-1 1I.
Williams, D. F., Ed., Sector Publishing, Ltd., Tunbridge Wells, (11) Swanson, S. A. V., and Freeman, M. A. R., The Scientific Basis of
1976, Chapt. 10. Joint Replacement, John Wiley and Sons, New York, N.Y. 1977,
(4) Sullivan, B., Homsy, C. A., Woods, G. W., and Tullos, H. S., pp. 46-85.
“Stabilization of Thompson Femoral Head Prosthesis with a (12) Homsy, C. A., et al, “Rapid In-Vitro Screening of Polymers for
Porous Stem Coating: A Case Report,” Clinical Orthopedics, Vol Biocompatibility,” Journal of Macromolecular Science, Chemistry,
132, 1978, p. 136. Vol A4, NO. 3, 1970, pp. 615-634.
(5) Rice, R. M., Hegyeli, A. F., Gourlay, S . J., Wade, C. W. R., Dillon, (13) Wilsnack, R. E., Meyer, F. J., and Smith, M. S., “Human Cell
J. G., Jaffe, H., and Kulkarni, R. K., “Biocompatibility Testing of Culture Testing of Medical Devices and Correlation to Animal
Polymers: In Vitro Studies with In Vivo Correlation,” Journal of Tests,’’ Bio-materials, Medical and Artificial Organs, Vol 1, 1973,
Biomedical Material Research, Vol 12, 1978, p. 43. pp. 543-562.
(6) Gourlay, S.J., Rice, R. M., Hegyeli, A. F., Wade, C.W. R., Dillon, (14) Wilsnack, R. E., “Quantitative Cell Culture Biocompatibility
J. G., Jaffe, H., and Kulkarni, R. K.,“Biocompatibility Testing of Testing of Medical Devices and Correlation to Animal Tests,”
Polymers: In Vivo Implantation Studies,” Joiirnal of Biomedical Biomaterials, Medical Devices and Artificial Organs, Vol 4, 1976,
Materials Research, Vol 12, 1978, p. 219. pp. 235-261.
(7) Harrison, J. H., “The Use of Teflon as a Blood Vessel Replacement (15) US.Pharmacopeia, Vol 21, 1985, pp. 1156-1160.
in Experimental Animals, Surgery, Gynecology, and Obstetrics, (16) Anderson, B. C., Barton, L. R., and Collette, J. W., Trends in
Vol 104, 1975, p. 81. Polymer Development, Science, 208,826, 1980.

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