1、Designation:F167214Standard Specification forResurfacing Patellar Prosthesis1This standard is issued under the fixed designation F1672;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses
2、indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers patellar resurfacing devicesused to provide a functioning articulation between the patellaand the femur.1.2 This specification is inten
3、ded to provide basic descrip-tions of material and device geometry.Additionally,thosecharacteristics determined to be important to in-vivo perfor-mance of the device are defined.1.3 This specification does not cover the details for qualityassurance,design control,and production control contained in2
4、1 CFR 820 and ISO 9001.NOTE1Devices for custom applications are not covered by thisspecification.2.Referenced Documents2.1 ASTM Standards:2F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and M
5、arking of Metal-lic Surgical ImplantsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Spec
6、ification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F451 Specification for Acrylic Bone CementF562 SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F563 Specificationfor
7、WroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications(UNS R30563)(With-drawn 2005)3F603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated F
8、orm for Surgical Im-plantsF732 Test Method for Wear Testing of Polymeric MaterialsUsed in Total Joint ProsthesesF745 Specificationfor18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications(Withdrawn2012)3F746 Test Method for Pitting or Crevice
9、 Corrosion ofMetallic Surgical Implant MaterialsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF799 Specification for Cobalt-28Chromium-6MolybdenumAlloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)F981 Practice for Assessment of Compatibility of Bioma
10、te-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1044 Test Method for Shear Testing of Calcium PhosphateCoatings and Metallic CoatingsF1108 Specification for Titanium-6Aluminum-4VanadiumAlloy Ca
11、stings for Surgical Implants(UNS R56406)F1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1160 Test Method for Shear and Bending Fatigue Testingof Calcium Phosphate and Metallic Medical and Compos-ite Calcium Phosphate/Metallic Coatings1This specification is under the
12、 jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is under the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved April 1,2014.Published April 2014.Originallyapproved in 1995.Last previous edition approved in 2011 as F1672 95(2011)
13、.DOI:10.1520/F1672-14.2For 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 historica
14、l standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.2 Government Document:21 CFR 820 Good Manufacturing Practice for MedicalDevices42.3 ISO Standard:ISO 9001 Quality Systems Model for Quality Assuranc
15、e inDesign/Development,Production,Installation,and Ser-vicing53.Terminology3.1 DefinitionsDimensions defined as follows are mea-sured in whole or in part in the sagittal,transverse,and coronal(or frontal)planes as appropriate.See Fig.1 and Fig.2.3.1.1 T1total overall prosthetic thickness,for example
16、,from the apex of the dome to the free end of pegs or otherfixation geometry.3.1.2 T2thickness of the patellar prosthesis from the planeof the bone-prosthesis interface(excluding pegs,keels,and soforth)to the apex of the articulating surface.3.1.3 T3minimum polymer thickness of the patellar pros-thesis in direct contact with the femoral component that is“atrisk”for wear;this is measured perpendicular to the tangent ofthe wear surface at the point of contact with the femoralcomponent.3.1.4 Discus
