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ASTM F755-99(2011)

(Specification)

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

ABSTRACT
This specification covers the raw material and final product requirements, and the associated test methods for the selection of porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications. Physical properties such as pore size and volume, as well as tensile, compressive, flexural, and shear properties shall be determined, but will be specified in the particular device to which its end use shall be applied.
SCOPE
1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications.
1.2 Evaluation of tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.
1.3 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may allow for the establishment of implant fixation.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This section 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

Status
Historical
Publication Date
30-Nov-2011
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F755-99(2005) - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Effective Date
01-Dec-2011
Replaced By
ASTM F755-19 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Effective Date
01-Dec-2019
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Dec-2011

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ASTM F755-99(2011) - Standard Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsASTM F755-99(2011) - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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ASTM F755-99(2011) - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F755 −99 (Reapproved 2011)
Standard Specification for
Selection of Porous Polyethylene for Use in Surgical
Implants
ThisstandardisissuedunderthefixeddesignationF755;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D1238Test Method for Melt Flow Rates of Thermoplastics
by Extrusion Plastometer
1.1 This specification covers the properties and test meth-
D1505Test Method for Density of Plastics by the Density-
ods for porous high density and ultra high molecular weight
Gradient Technique
polyethylenesintendedforuseinsurgicalimplants.Theporous
D1621Test Method for Compressive Properties of Rigid
polyethylene may be used as a free standing product or as a
Cellular Plastics
coating on a substrate in nonloaded applications.
D1623Test Method for Tensile and TensileAdhesion Prop-
1.2 Evaluation of tissue response to a porous polyethylene
erties of Rigid Cellular Plastics
must be completed. Guidance in establishing biocompatibility 3
D1898Practice for Sampling of Plastics (Withdrawn 1998)
may be found in the list of references.
D2238TestMethodsforAbsorbanceofPolyethyleneDueto
−1
1.3 Clinicalexperienceandanimalstudieshaveshownthat Methyl Groups at 1378 cm
D2873Test Method for Interior Porosity of Poly(Vinyl
tissue will grow into the open pores of porous polyethylene.
The tissue ingrowth into the pores may allow for the establish- Chloride) (PVC) Resins by Mercury Intrusion Porosim-
etry (Withdrawn 2003)
ment of implant fixation.
E562Test Method for Determining Volume Fraction by
1.4 The values stated in SI units are to be regarded as
Systematic Manual Point Count
standard. No other units of measurement are included in this
F316Test Methods for Pore Size Characteristics of Mem-
standard.
brane Filters by Bubble Point and Mean Flow Pore Test
1.5 This section does not purport to address all of the safety
F648Specification for Ultra-High-Molecular-Weight Poly-
concerns, if any, associated with its use. It is the responsibility
ethylene Powder and Fabricated Form for Surgical Im-
of the user of this standard to establish appropriate safety and
plants
health practices and determine the applicability of regulatory
F748PracticeforSelectingGenericBiologicalTestMethods
limitations prior to use.
for Materials and Devices
F763Practice for Short-Term Screening of Implant Materi-
2. Referenced Documents
als
2.1 ASTM Standards:
F981Practice for Assessment of Compatibility of Biomate-
D638Test Method for Tensile Properties of Plastics
rials for Surgical Implants with Respect to Effect of
D732Test Method for Shear Strength of Plastics by Punch
Materials on Muscle and Bone
Tool
2.2 Other Documents:
D790Test Methods for Flexural Properties of Unreinforced
Code of Federal RegulationsTitle 21, Paragraph 177.1520
and Reinforced Plastics and Electrical Insulating Materi-
U.S. Pharmacopeia,Vol 23, 1995
als
3. Significance and Use
D883Terminology Relating to Plastics
3.1 Porous polyethylene is a matrix of substantially open
cells, interconnected to form multidirectional paths. Perfor-
This specification is under the jurisdiction of ASTM Committee F04 on
mance of these structures, including tissue ingrowth, depends
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.11 on Polymeric Materials.
Current edition approved Dec. 1, 2011. Published January 2012. Originally The last approved version of this historical standard is referenced on
approved in 1982. Last previous edition approved in 2005 as F755 –99 (2005). www.astm.org.
DOI: 10.1520/F0755-99R11. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.access.gpo.gov.
Standards volume information, refer to the standard’s Document Summary page on AvailablefromU.S.Pharmacopeia(USP),12601TwinbrookPkwy.,Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F755−99 (2011)
upon the biocompatibility of the polymer, average pore and 5.4 The porous product shall be inspected under 8×
interstitial opening diameters (ordinarily referred to as average magnification to assure that the surface porosity is open.
poresize)inconjunctionwithvoidvolume(referredtoaspore
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
3.2 Thisspecificationisapplicabletoalldevicestandardsin value unless the end-use application requires less deviation.
which a porous polyethylene is used. A complete list of end
5.6 Porous product quality and uniformity shall be assured
uses has not been established. In those cases where the use of
by the appropriate test methods as specified by vendor-user
aporouspolyethylenehasnotbeenestablished,themechanical
agreement and listed in Section 6.
and physical characteristics required shall be determined by
propertesting.Theporesize,porevolume,andthemechanical
6. Test Methods
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
4. Raw Material Requirements
point analysis on a total ossicular replacement, while mercury intrusion
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-densitypolyethyleneshallexhibitadensityofnot
6.2 Average pore size shall be established by appropriate
less than 0.941 g/cm when tested in accordance with Test
Method D1505. test methods such as is found in Test Method F316 or by
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 produc
...

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