ASTM F755-99(2005)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F755 – 99 (Reapproved 2005)
Standard Specification for
Selection of Porous Polyethylene for Use in Surgical
Implants
ThisstandardisissuedunderthefixeddesignationF755;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D1623 Test Method for Tensile and TensileAdhesion Prop-
erties of Rigid Cellular Plastics
1.1 This specification covers the properties and test meth-
D1898 Practice for Sampling of Plastics
ods for porous high density and ultra high molecular weight
D2238 Test Methods for Absorbance of Polyethylene Due
polyethylenesintendedforuseinsurgicalimplants.Theporous
Ø1 3
to Methyl Groups at 1378 cm
polyethylene may be used as a free standing product or as a
D2873 Test Method for Interior Porosity of Poly(Vinyl
coating on a substrate in nonloaded applications.
Chloride) (PVC) Resins by Mercury Intrusion Porosim-
1.2 Evaluation of tissue response to a porous polyethylene
etry
must be completed. Guidance in establishing biocompatibility
E562 Test Method for Determining Volume Fraction by
may be found in the list of references.
Systematic Manual Point Count
1.3 Clinical experience and animal studies have shown that
F316 Test Methods for Pore Size Characteristics of Mem-
tissue will grow into the open pores of porous polyethylene.
brane Filters by Bubble Point and Mean Flow Pore Test
The tissue ingrowth into the pores may allow for the establish-
F469 Practice for Assessment of Compatibility of Nonpo-
ment of implant fixation.
rous Polymeric Materials for Surgical Implants With Re-
1.4 This section does not purport to address all of the safety
gard to Effect of Materials on Tissue
concerns, if any, associated with its use. It is the responsibility
F648 Specification for Ultra-High-Molecular-Weight Poly-
of the user of this standard to establish appropriate safety and
ethylene Powder and Fabricated Form for Surgical Im-
health practices and determine the applicability of regulatory
plants
limitations prior to use.
F748 Practice for Selecting Generic Biological Test Meth-
2. Referenced Documents ods for Materials and Devices
F763 Practice for Short-Term Screening of Implant Materi-
2.1 ASTM Standards:
als
D638 Test Method for Tensile Properties of Plastics
F981 Practice forAssessment of Compatibility of Biomate-
D732 Test Method for Shear Strength of Plastics by Punch
rials for Surgical Implants with Respect to Effect of
Tool
Materials on Muscle and Bone
D790 Test Methods for Flexural Properties of Unreinforced
2.2 Other Documents:
and Reinforced Plastics and Electrical Insulating Materials
Code of Federal Regulations Title 21, Paragraph 177.1520
D883 Terminology Relating to Plastics
U.S. Pharmacopeia, Vol 23, 1995
D1238 Test Method for Melt Flow Rates of Thermoplastics
by Extrusion Plastometer
3. Significance and Use
D1505 Test Method for Density of Plastics by the Density-
3.1 Porous polyethylene is a matrix of substantially open
Gradient Technique
cells, interconnected to form multidirectional paths. Perfor-
D1621 Test Method for Compressive Properties Of Rigid
mance of these structures, including tissue ingrowth, depends
Cellular Plastics
upon the biocompatibility of the polymer, average pore and
interstitial opening diameters (ordinarily referred to as average
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 Mar. 1, 2005. Published March 2005. Originally Withdrawn.
´1 4
approved in 1982. Last previous edition approved in 1999 as F755 – 99 . DOI: Withdrawn. The last approved version of this historical standard is referenced
10.1520/F0755-99R05. on www.astm.org.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F755 – 99 (2005)
pore size) in conjunction with void volume (referred to as pore 5.5 The average pore size shall be specified by vendor-user
volume or percent porosity). agreement and shall be held to within 20 % of the nominal
value unless the end-use application requires less deviation.
3.2 This specification is applicable to all device standards in
5.6 Porous product quality and uniformity shall be assured
which a porous polyethylene is used. A complete list of end
by the appropriate test methods as specified by vendor-user
uses has not been established. In those cases where the use of
agreement and listed in Section 6.
aporouspolyethylenehasnotbeenestablished,themechanical
and physical characteristics required shall be determined by
6. Test Methods
proper testing.The pore size, pore volume, and the mechanical
properties will be specified in the particular device standard. NOTE 1—The shape and end use of the porous product dictates which
tests are appropriate. For example, it is impossible to perform a bubble
point analysis on a total ossicular replacement, while mercury intrusion
4. Raw Material Requirements
porosimetry is quite acceptable. A flexural test may be an acceptable
4.1 Thepolyethyleneplasticshallconsistofbasicpolymers
nondestructive test where tensile strength tests are destructive.
made with ethylene as essentially the sole monomer as defined
6.1 All mechanical and physical tests shall be sampled as
in Terminology D883.
required in Practice D1898.
4.2 High-density polyethylene shall exhibit a density of not
6.2 Average pore size shall be established by appropriate
less than 0.941 g/cm when tested in accordance with Test
test methods such as is found in Test Method F316 or by
Method D1505.
mercury intrusion porosimetry. Test Method D2873 is an
4.3 Ultra-high-molecular-weight polyethylene shall con-
acceptable method.
form to those sections of Specification F648 that apply to base
6.3 Average pore volume shall be established using one of
resin.
the following methods:
4.4 Particular raw materials shall contain no dirt or other
6.3.1 Pore volume can be measured by mercury intrusion
foreign matter which will cause the end product to fail to meet
porosimetry. Test Method D2873 is an acceptable method.
the product requirement specified in 5.2. 6.3.2 Pore volume can be
...