ASTM_F_755_-_99_2011.pdf

Designation:F75599(Reapproved 2011)Standard Specification forSelection of Porous Polyethylene for Use in SurgicalImplants1This standard is issued under the fixed designation F755;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1This specification covers the properties and test meth-ods for porous high density and ultra high molecular weightpolyethylenes intended for use in surgical implants.The porouspolyethylene may be used as a free standing product or as acoating on a substrate in nonloaded applications.1.2Evaluation of tissue response to a porous polyethylenemust be completed.Guidance in establishing biocompatibilitymay be found in the list of references.1.3 Clinical experience and animal studies have shown thattissue will grow into the open pores of porous polyethylene.The tissue ingrowth into the pores may allow for the establish-ment of implant fixation.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This section does not purport to address all of the safetyconcerns,if any,associated with its use.It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D638 Test Method for Tensile Properties of PlasticsD732 Test Method for Shear Strength of Plastics by PunchToolD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD883 Terminology Relating to PlasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1621 Test Method for Compressive Properties of RigidCellular PlasticsD1623 Test Method for Tensile and Tensile Adhesion Prop-erties of Rigid Cellular PlasticsD1898 Practice for Sampling of Plastics(Withdrawn 1998)3D2238 Test Methods forAbsorbance of Polyethylene Due toMethyl Groups at 1378 cm1D2873 Test Method for Interior Porosity of Poly(VinylChloride)(PVC)Resins by Mercury Intrusion Porosim-etry(Withdrawn 2003)3E562 Test Method for Determining Volume Fraction bySystematic Manual Point CountF316 Test Methods for Pore Size Characteristics of Mem-brane Filters by Bubble Point and Mean Flow Pore TestF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF763 Practice for Short-Term Screening of Implant Materi-alsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 Other Documents:Code of Federal Regulations Title 21,Paragraph 177.15204U.S.Pharmacopeia,Vol 23,199553.Significance and Use3.1Porous polyethylene is a matrix of substantially opencells,interconnected to form multidirectional paths.Perfor-mance of these structures,including tissue ingrowth,depends1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Dec.1,2011.Published January 2012.Originallyapproved in 1982.Last previous edition approved in 2005 as F755 99(2005).DOI:10.1520/F0755-99R11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.5Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 upon the biocompatibility of the polymer,average pore andinterstitial opening diameters(ordinarily referred to as averagepore size)in conjunction with void volume(referred to as porevolume or percent porosity).3.2 This specification is applicable to all device standards inwhich a porous polyethylene is used.A complete list of enduses has not been established.In those cases where the use ofa porous polyethylene has not been established,the mechanicaland physical characteristics required shall be determined byproper testing.The pore size,pore volume,and the mechanicalproperties will be specified in the particular device standard.4.Raw Material Requirements4.1 Th