ASTM F755-99

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: F 755 – 99
Standard Specification for
Selection of Porous Polyethylene for Use in Surgical
Implants
This standard is issued under the fixed designation F 755; 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 2
1. Scope to Methyl Groups at 1378 cm
D 2873 Test Method for Interior Porosity of Poly(Vinyl
1.1 This specification covers the properties and test meth-
Chloride) (PVC) Resins by Mercury Intrusion Porosim-
ods for porous high density and ultra high molecular weight
etry
polyethylenes intended for use in surgical implants. The porous
E 562 Practice for Determining Volume Fraction by Sys-
polyethylene may be used as a free standing product or as a
tematic Manual Point Count
coating on a substrate in nonloaded applications.
F 316 Test Method for Pore Size Characteristics of Mem-
1.2 Evaluation of tissue response to a porous polyethylene
brane Filters for Use with Aerospace Fluids
must be completed. Guidance in establishing biocompatibility
F 469 Practice for Assessment of Compatibility of Nonpo-
may be found in the list of references.
rous Polymeric Materials for Surgical Implants With Re-
1.3 Clinical experience and animal studies have shown that
gard to Effect of Materials on Tissue
tissue will grow into the open pores of porous polyethylene.
F 648 Specification for Ultra-High-Molecular-Weight Poly-
The tissue ingrowth into the pores may allow for the establish-
ethylene Powder and Fabricated Form for Surgical Im-
ment of implant fixation.
plants
1.4 This section does not purport to address all of the safety
F 748 Practice for Selecting Generic Biological Test Meth-
concerns, if any, associated with its use. It is the responsibility
ods for Materials and Devices
of the user of this standard to establish appropriate safety and
F 763 Practice for Short-Term Screening of Implant Mate-
health practices and determine the applicability of regulatory
rials
limitations prior to use.
F 981 Practice for Assessment of Compatibility of Bioma-
2. Referenced Documents terials (Non-porous) for Surgical Implants with Respect to
Effect of Materials on Muscle and Bone
2.1 ASTM Standards:
2.2 Other Documents:
D 638 Test Method for Tensile Properties of Plastics
Code of Federal Regulations Title 21, Paragraph 177.1520.
D 732 Test Method for Shear Strength of Plastics by Punch
U. S. Pharmacopeia XXIII, 1995
Tool
D 790 Test Methods for Flexural Properties of Unreinforced
3. Significance and Use
and Reinforced Plastics and Electrical Insulating Materi-
3.1 Porous polyethylene is a matrix of substantially open
als
cells, interconnected to form multidirectional paths. Perfor-
D 883 Definitions of Terms Relating to Plastics
mance of these structures, including tissue ingrowth, depends
D 1238 Test Method for Flow Rates of Thermoplastics by
2 upon the biocompatibility of the polymer, average pore and
Extrusion Plastometer
interstitial opening diameters (ordinarily referred to as average
D 1505 Test Method for Density of Plastics by the Density-
2 pore size) in conjunction with void volume (referred to as pore
Gradient Technique
volume or percent porosity).
D 1621 Test Method for Compressive Properties of Rigid
2 3.2 This specification is applicable to all device standards in
Cellular Plastics
which a porous polyethylene is used. A complete list of end
D 1623 Test Method for Tensile and Tensile Adhesion
2 uses has not been established. In those cases where the use of
Properties of Rigid Cellular Plastics
a porous polyethylene has not been established, the mechanical
D 1898 Practice for Sampling of Plastics
and physical characteristics required shall be determined by
D 2238 Test Methods for Absorbance of Polyethylene Due
proper testing. The pore size, pore volume, and the mechanical
properties will be specified in the particular device standard.
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
F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 08.02.
Current edition approved August 10, 1999. Published September 1999. Origi- Annual Book of ASTM Standards, Vol 03.01.
nally published as F 755 – 82. Last previous edition F 755 – 98. Discontinued—See 1995 Annual Book of Standards, Vol 11.02.
2 6
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 755
4. Raw Material Requirements 6. Test Methods
4.1 The polyethylene plastic shall consist of basic polymers
NOTE 1—The shape and end use of the porous product dictates which
made with ethylene as essentially the sole monomer as defined
tests are appropriate. For example, it is impossible to perform a bubble
point analysis on a total ossicular replacement, while mercury intrusion
in Terminology D 883.
porosimetry is quite acceptable. A flexural test may be an acceptable
4.2 High-density polyethylene shall exhibit a density of not
3 nondestructive test where tensile strength tests are destructive.
less than 0.941 g/cm when tested in accordance with Test
Method D 1505.
6.1 All mechanical and physical tests shall be sampled as
4.3 Ultra-high-molecular-weight polyethylene shall con- required in Practice D 1898.
form to those sections of Specification F 648 that apply to base
6.2 Average pore size shall be established by appropriate
resin. test methods such as is found in Method F 316 or by mercury
4.4 Particular raw materials shall contain no dirt or other
intrusion porosimetry. Test Method D 2873 is an acceptable
foreign matter which will cause the end product to fail to meet method.
the product requirement specified in 5.2.
6.3 Average pore volume shall be established using one of
4.5 The polyethylene resin shall conform to all parts of the following methods:
Paragraph 177.1520 of Title 21 which apply to polyethylene.
6.3.1 Pore volume can be measured by mercury intrusion
4.6 The polymer shall be characterized by determining the porosimetry. Test Method D 2873 is an acceptable method.
infrared absorption spectrum. An acceptable procedure may be
6.3.2 Pore volume can be approximated by measurement of
found in Test Methods D 2238.
weight of a nonsolvent saturant of known gravity and relating
4.7 The polymer shall be characterized by one or more of
its volume to the matrix volume.
the following test methods:
6.3.3 Pore volume can be estimated
...