ASTM F3018-2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices《评估硬-硬关节置换全髋关节置换和髋关节表面置换装置的标准指南》.pdf

1、Designation: F3018 17Standard Guide forAssessment of Hard-on-Hard Articulation Total HipReplacement and Hip Resurfacing Arthroplasty Devices1This standard is issued under the fixed designation F3018; the number immediately following the designation indicates the year oforiginal adoption or, in the c

2、ase of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide covers materials and design recommenda-tions and general test methods for the

3、chemical, mechanical,and preclinical assessment of implantable devices with hard-on-hard articulations intended to replace a hip joint. Theprovided guidance is intended to encompass both Total HipReplacement (THR) devices with stems that extend or fixwithin the intramedullary canal as well as Hip Re

4、surfacingArthroplasty (HRA) wherein only the hip articulating surfacesare replaced. There has been long term clinical experience withmetal-on-metal articulating components manufactured fromcobalt-28 % chromium-6 % molybdenum (Co28Cr6Mo) alloy(Specifications F75, F799,orF1537) or high purity alumina(

5、ISO 6474-1) and ceramic-on-ceramic articulating componentsmanufactured from high purity alumina (ISO 6474-1) oralumina matrix composite ceramics (ISO 6474-2). There hasalso been some limited clinical experience with metal(Co28Cr6Mo) on alumina matrix composite ceramic articulat-ing components. This

6、guide has been created based on thecurrent understanding derived from those clinical histories.Device articulating components manufactured from other me-tallic alloys, ceramics or with coated or elementally modifiedarticulating surfaces could also be evaluated with this guide.However, such materials

7、 that do not have a history of clinicaluse may present different risks.1.2 This guide applies to the acetabular and femoral articu-lating components of hard-on-hard hip replacement devices.Acetabular components can be monoblock, or a modularcomponent with a separate acetabular shell and acetabularli

8、ner.As stated above, articulating components have been madefrom Co28Cr6Mo for a metal-on-metal bearing; high purityalumina or alumina matrix composite ceramics for a ceramic-on-ceramic bearing; and Co28Cr6Mo and alumina matrixcomposite (ISO 6474-2) for a metal-on-ceramic bearing.Modular acetabular s

9、hells have to date been made fromTi-6Al-4V or Co28Cr6Mo. The shell is considered part of theacetabular component. Acetabular components may have ex-ternal coating and/or porous structure intended foruncemented, press-fit or biological fixation; or, for use withbone cement.1.3 This standard is a summ

10、ary of available specifications,test methods, practices, and guides from published standards orthe scientific literature. Their clinical relevance is unproven.Most of the methods do not have an established precision andbias; therefore, their repeatability and reproducibility has notbeen established.

11、 As the clinical relevance of these methodshave not been established, consequently, most do not haveperformance requirements. This document does not requirethat all the listed methodologies are always necessary toevaluate these implant systems provided justification for notusing each unused method i

12、s provided. This document does notintend to prevent the use of new methodologies as they aredeveloped.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, healt

13、h and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of Internatio

14、nal Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F136 Specific

15、ation for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial)Alloy for SurgicalImplant Applications (UNS R56401)1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthr

16、oplasty.Current edition approved Sept. 1, 2017. Published September 2017. DOI:10.1520/F3018-172For 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

17、 Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Princ

18、iples for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1F561 Practice for Retrieval and Analysis of MedicalDevices, and Associated Tissues and FluidsF799 Specification for Cobalt-28Chromium-6M

19、olybdenumAlloy Forgings for Surgical Implants (UNS R31537,R31538, R31539)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNSR31537, UNS R31538, and UNS R31539)F1814 Guide for Evaluating Modular Hip and Knee JointComponentsF1820 Test Method for Determining

20、the Forces for Disas-sembly of Modular Acetabular DevicesF1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF1877 Practice for Characterization of ParticlesF2033 Specification for Total Hip Joint Prosthesis and HipEndoprosthesis Bearing Surfaces Made of Metallic,Cera

21、mic, and Polymeric MaterialsF2068 Specification for Femoral ProsthesesMetallic Im-plantsF2091 Specification for Acetabular ProsthesesF2345 Test Methods for Determination of Static and CyclicFatigue Strength of Ceramic Modular Femoral HeadsF2582 Test Method for Impingement of Acetabular Prosthe-sesF3

22、047M Guide for High Demand Hip Simulator Wear Test-ing of Hard-on-hard Articulations2.2 ISO Standards:3ISO 1302 Geometrical Product Specifications (GPS) - In-dication of surface texture in technical product documen-tationISO 4287 Geometrical Product Specifications (GPS) - Sur-face texture: Profile m

23、ethod - Terms, definitions andsurface texture parametersISO 4288 Geometrical Product Specifications (GPS) - Sur-face texture: Profile method - Rules and procedures forthe assessment of surface textureISO 5832-3 Implants for surgery - Metallic materials Part3: Wrought titanium 6-aluminium 4vanadium a

24、lloyISO 5832-4 Implants for surgery - Metallic materials - Part4: Cobalt-chromium-molybdenum casting alloyISO 5832-12 Implants for surgery - Metallic materials -Part 12: Wrought cobalt-chromiummolybdenum alloyISO 6474-1 Implants for surgery - Part 1: Ceramic materialsbased on high purity aluminaISO

25、6474-2 Implants for surgery - Part 2: Compositematerials based on a high purity alumina matrix withzirconia reinforcementISO 7206-1 Implants for surgery - Partial and total hip jointprostheses - Part 1: Classification and designation ofdimensionsISO 7206-2 Implants for surgery - Partial and total hi

26、p jointprostheses - Part 2: Articulating surfaces made ofmetallic, ceramic and plastics materialsISO 7206-4 Implants for surgery - Partial and total hip jointprostheses - Part 4: Determination of endurance proper-ties and performance of stemmed femoral componentsISO 7206-6 Implants for surgery - Par

27、tial and total hip jointprostheses - Part 6: Endurance properties testing andperformance requirements of neck region of stemmedfemoral componentsISO 7206-10 Implants for surgery - Partial and total hipjoint prostheses - Part 10: Determination of resistance tostatic load of modular femoral headsISO 7

28、206-12 Implants for surgery - Partial and total hipjoint prostheses Part 12: Deformation test method foracetabular shellsISO 7206-13 Implants for surgery - Partial and total hipjoint prostheses - Part 13: Determination of resistance totorque of head fixation of stemmed femoral componentsISO 14242-1

29、Implants for surgery - Wear of total hip-jointprostheses - Part 1: Loading and displacement parametersfor wear-testing machines and corresponding environmen-tal conditions for testISO 14242-2 Implants for surgery - Wear of total hip-jointprostheses - Part 2: Methods of MeasurementISO 14242-3 Implant

30、s for surgery - Wear of total hip-jointprostheses - Part 3: Loading and displacement parametersfor orbital bearing type wear testing machines and corre-sponding environmental conditions for testISO 17853 Wear of implant materials - Polymer and metalwear particles - Isolation, characterization and qu

31、antifi-cationISO 21535 Non-active surgical implants - Joint replacementimplants - Specific requirements for hip-joint replace-ment implantsISO 25178-6 Geometrical product specifications (GPS) -Surface texture: areal - Part 6: Classification of methodsfor measuring surface texture2.3 Other Standards:

32、ASME Y14.36M Surface Texture SymbolsUS FDA 510(k) Information needed for HydroxyapatiteCoated Orthopedic Implants March 10, 1995 (revised Feb.20, 1997)43. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 alloy fabricated form, nthe raw material form of themetallic alloy and any pr

33、ocessing techniques used to fabricatethe final form of the implant.3.1.2 breakaway wear, na higher unexpected wear ratethat follows a period of steady-state wear as illustrated in Fig.1. (1)53.1.3 breakaway wear with recovery, nbreakaway wearthat returns to lower steady-state wear rates. The breakaw

34、ay/recovery phenomenon can be a single event or multipleepisodic events during the steady-state conditions as illus-trated in Fig. 1.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Submission and Review of Sterility Info

35、rmation in Premarket Notification(510(k) Submissions for Devices Labeled as Sterile, issued January 21, 2016,updated March 16, 2016.5The boldface numbers in parentheses refer to a list of references at the end ofthis standard.F3018 1723.1.4 ceramic material sample, nny bulk shape of hardinorganic no

36、n-metallic ceramic materials that is prepared to thefinal physical, chemical, and mechanical material propertiesspecified for the implant component before packaging andsterilization.3.1.5 ceramic-on-ceramic hip articulation, na device in-tended to replace a human hip joint in which the femoral andac

37、etabular articulating surfaces are composed of ceramic.Clinical history exists for high purity alumina or aluminamatrix composite ceramics in this application. Other ceramicmaterials have not yet had a history of clinical use.3.1.6 contact patch, nan estimated contact area betweenthe acetabular and

38、the femoral articulating surfaces for a givenjoint reaction force3.1.7 contact patch edge to rim (CPER) distance, nfor agiven acetabular component orientation the arc distance be-tween the edge of the contact patch ata3kNjoint reactionFIG. 1 Modes/Phases of Wear Illustrated Schematically (1)FIG. 2 I

39、llustration of Contact Patch Edge to Rim DistanceF3018 173force and the last portion of articulating surface on theacetabular component as illustrated in Fig. 2.3.1.8 cup articular arc angle (CAAA), nthe angle sub-tended by the articular surface of the acetabular component. Itcan be determined with

40、a computeraided design system ormanual measurements. With a head placed in the acetabularliner, it is the minimum angle in a plane bisecting the femoralhead and the liner, formed by the last contacts between thehead and liner, and the rotational center of the head. It isillustrated in Fig. 3. The me

41、asurement applies to both THR andHRA systems.3.1.9 diametral clearance, nthe diameter of the acetabulararticulating surface minus the diameter of the femoral articularsurface.3.1.10 hip bearing couple, na usually spherical ball andcup system intended to articulate against each other as areplacement

42、for the articulating surfaces of the natural hip.3.1.11 metal-on-metal hip prosthesis, na device intendedto replace a human hip joint in which the ball and cuparticulating surfaces are historically composed of Co28Cr6Mocobalt alloy. The ball is attached to an intramedullary stem inTHR systems.FIG. 3

43、 Illustration of Cup Articular Arc AngleFIG. 4 Illustration of Edge Loading Due to MicroseparationF3018 1743.1.12 microseparation, na dynamic condition that canoccur in where the centers of rotation of the femoral head andthe acetabular cup are displaced during an activity. This canlead to edge load

44、ing where the femoral head contacts the rim.It is illustrated in Fig. 4. The phenomenon is relevant to bothTHR and HRA systems.3.1.13 modular acetabular device, na modular acetabularsystem consisting of a minimum of two components, one ofwhich includes the bearing surface and the second componentis

45、a modular acetabular shell intended to contain the bearingliner and contact bone or bone cement.3.1.14 modular acetabular linerportion of the modularacetabular device with an internal hemispherical socket in-tended to articulate with the head of a femoral prosthesis. Theexternal geometry of this com

46、ponent interfaces with theacetabular shell through a locking mechanism which may beintegral to the design of the liner and shell or may rely uponadditional components (for example, metal ring, screws, and soforth).3.1.15 modular acetabular shell, nthe external, hollowstructure, usually metallic, tha

47、t provides additional mechanicalsupport or reinforcement for an acetabular liner and whoseexternal features interface directly with the bones of the pelvicsocket (for example, through bone cement, intimate press-fit,coatings for attachment to bone cement or tissue, integralscrew threads, anchoring s

48、crews, pegs, and so forth). Theacetabular shell may be solid or contain holes for fixation orattachment of instrumentation.3.1.16 monoblock acetabular device, nan acetabular sys-tem manufactured as a single piece3.1.17 runaway wear, nan initial high wear rate thatshows no sign of achieving a lower s

49、teady-state wear rate asillustrated in Fig. 1.3.1.18 run-in wear, nwear rate that occurs when thecomponents are first implanted in vivo, or during the initialphase of an in vitro hip simulator test. During this period, wearrates are typically higher than during steady state as thearticulating surfaces wear into conformity with each other andany initially contacting surface asperities or form errors areworn away as illustrated in Fig. 1. In hip simulator wear testsit is often considered to be about one million cycles