ASTM_F_1715_-_00e1.pdf

Designation:F 1715 00e1Standard Guide forWear Assessment of Prosthetic Knee Designs in SimulatorDevices1This standard is issued under the fixed designation F 1715;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.e1NOTESection 2 was editorially corrected in June 2001.1.Scope1.1 This guide covers a laboratory method for evaluating thewear properties of materials or devices,or both,that are beingconsidered for use as the bearing surfaces of human knee jointreplacement prostheses.The knee prostheses are evaluated in adevice intended to simulate the tribological conditions encoun-tered in the human knee joint.1.2 The methods described in this guide are intended toapply to a number of fundamentally different types of kneewear simulators.These include apparatuses which are designedto apply some combination of axial load,flexion/extensionangular motion,AP displacement or shear force,and tibialrotational displacement or torque to femoral and tibial wear testspecimens.1.3 Since the knee simulator method permits the use ofactual implant designs,materials,and physiological load/motion combinations,it can represent a more physiologicalsimulation than basic wear-screening tests,such as“pin-on-disc”(Test Method F 732)or“ring-on-disc”(ISO-6474).1.4 It is the intent of this guide to rank the combination ofimplant designs and materials with regard to material wearrates under simulated physiological conditions.It must berecognized,however,since there are many possible variationsin the in vivo conditions,a single-laboratory simulation with afixed set of parameters may not be universally representative.(1,2)21.5 The reference materials for the comparative evaluationof candidate materials,designs,and processes shall be the wearrate of extruded or compression-molded ultra-high molecularweight(UHMW)polyethylene(Specification F 648)bearingagainst standard counter faces cobalt-chromium-molybdenumalloy(Specification F 75);thermomechanically processed co-balt chrome(Specification F 799 or F 1537),having typicalprosthetic-quality surface finish and geometry similar to thosewith established clinical history.These reference materials willhave been tested under the same wear conditions as thecandidate materials.2.Referenced Documents2.1 ASTM Standards:D 883 Terminology Relating to Plastics3F 75 Specification for Cast Cobalt-Chromium-MolybdenumAlloy for Surgical Implant Applications4F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants5F 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plants5F 732 Test Method for Pin-on-Flat Wear Test for PolymericMaterials for Used in Total Joint Prostheses Which Expe-rience Linear Reciprocating Wear Motion5F 799 Specification for Thermomechanically ProcessedCobalt-Chrome-Molybdenum Alloy for Surgical Implants5F 1537 Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants5F 2025 Practice for Gravimetric Measurement of PolymericComponents for Wear Assessment5G 40 Terminology Relating to Erosion and Wear52.2ISO Standard:ISO 6474 Implants for SurgeryCeramic Materials Basedon Alumina63.Terminology3.1 DefinitionsFor definitions of terms in this guide relat-ing to plastics,refer to Definitions D 883.For definitionsrelating to erosion and wear,refer to Terminology G 40.3.2 Definitions of Terms Specific to This Standard:3.2.1 wear,nthe progressive loss of material from aprosthetic component as a result of tangential motion against1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.22on Arthroplasty.Current edition approved May 10,2000.Published August 2000.Originallypublished as F 1715 96.Last previous edition F 1715 96.2The boldface numbers given in parentheses refer to the list of references at theend of the text.3Annual Book of ASTM Standards,Vol 08.01.4Annual Book of ASTM Standards,Vol 13.01.5Annual Book of ASTM Standards,Vol 03.02.6Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.its mating component under load.4.Significance and Use4.1 This guide provides general guidelines for establishingtest conditions,obtaining wear measurements,and determiningthe appropriateness of results for wear simulation of thefemoro-tibial components of knee joint prostheses.Fundamen-tal aspects of these methods include the use of bovine serum ordemonstrated equivalent lubricant,and use of dynamic loadand motion profiles representative of the human knee jointduring activities of daily living.(3)The addition or substitutionof other patient activiti