ASTM_F_370_-_94_1999.pdf

Designation:F 370 94(Reapproved 1999)Standard Specification forProximal Femoral Endoprosthesis1This standard is issued under the fixed designation F 370;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 indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the materials,functional di-mensions,and tolerances for single piece,metallic proximalfemoral endoprosthesis.1.2 In recognition of many broad and varied uses of suchprostheses,many options are included.A variety,but notnecessarily all,of the options are illustrated in Fig.1.1.3 The values stated in inch-pound units are to be regardedas the standard.2.Referenced Documents2.1 ASTM Standards:F 55 Specification for Stainless Steel Bar and Wire forSurgical Implants2F 75 Specification for Cast Cobalt-Chromium-MolybdenumAlloy for Surgical Implant Applications2F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants2F 136 Specification for Wrought Titanium 6A1-4V ELIAlloy for Surgical Implant Applications2F 138 Specification for Stainless Steel Bar and Wire forSurgical Implants(Special Quality)2F 601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical Implants2F 620 Specification for Titanium 6A1-4V ELI Alloy Forg-ings for Surgical Implants2F 621 Specification for Stainless Steel Forgings for SurgicalImplants2F 629 Practice for Radiography of Cast Metallic SurgicalImplants2F 983 Practice for Permanent Marking of Orthopedic Im-plant Components2F 1108 Specification for Cast Titanium 6A1-4V Alloy forSurgical Implants22.2ASQC Standard:C1-1985 Specification of General Requirements for a Qual-ity Control Program33.Materials3.1 Proximal femoral endoprosthesis conforming to thisspecification shall be made of a material conforming to one ofthe following Specifications:F 55,F 75,F 136,F 138,orF 1108.3.2 Proximal femoral endoprostheses made from stainlesssteel or titanium alloy forgings shall conform to one of thefollowing,as applicable;Specifications F 620 or F 621.4.Dimensions4.1 Proximal femoral endoprosthesis conforming to thisspecification shall be fabricated in accordance with the toler-ances indicated for specific dimensions illustrated in Fig.2 ofthis specification.Where tolerances are not indicated fordimensions the following tolerances shall apply:Fractional dimen-sions6164in.(0.40 mm)Decimal dimensions60.005 in.(0.13 mm)Angles62Metric dimensions60.5 mm(0.019 in.)5.Finish and Marking5.1 Proximal femoral endoprosthesis conforming to thisspecification shall be finished in accordance with Practice F 86.5.2 Permanent identification marking on proximal femoralendoprostheses conforming to this specification shall be inaccordance with F 983.Such markings shall include thefollowing:5.2.1 Head size(spherical diameter)5.2.2 Stem length5.2.3 Manufacturers name and/or logo5.2.4 Lot number or serial number5.2.5 Catalogue number6.Quality Program Requirements6.1 The manufacturer shall maintain a quality program,such as,for example,is defined in the ASQC C1-1985.6.2 Nondestructive inspection,as appropriate to the methodof manufacturer,shall be used to ensure prostheses quality.Fluorescent penetrant inspection and radiography,when used,shall be in accordance with Practices F 601 and F 629 respec-tively.1This specification is under the jurisdiction ofASTM Committee F-4 on Medicaland Surgical Materials and Devices,and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Feb.15,1994.Published March 1994.Originallypublished as F 370 73.Last previous edition F 370 73(1991)e1.2Annual Book of ASTM Standards,Vol 13.01.3Available fromAmerican Society of Quality Control,161 West WisconsinAve.,Milwaukee,WI 53203.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.(a)Long Fenestrated Moore(c)Mller(b)Thompson(d)LeinbachFIG.1 Proximal Femoral EndoprosthesisTypical ExamplesF 3702APPENDIX(Nonmandatory Information)X1.(RATIONALE)X1.1This standard specification describes the basic fea-tures of classic femoral prostheses used for hemiarthroplasty ofthe hip(commonly termed endoprostheses).This specificationapplies to prostheses of fixed head construction only.X1.2More detailed requirements for this class of hipimplant,including those of modular and bi-polar construction,are currently under development as part of comprehensivephysical and performance standards for all hip prostheses.Thisrevision of F 370 is intended to reflect current industry practiceand to include reference to relevant ASTM standards passedsince its last revision.In accordance with reflecting industrypractice for this class of prostheses,primary dimensions arelisted in inch-pound units.X1.3This standard is not meant to be perfect but to serveuntil the comprehensive standards are ready.When the com-preh