ASTM_F_1781_-_15.pdf

Designation:F178115Standard Specification forElastomeric Flexible Hinge Finger Total Joint Implants1This standard is issued under the fixed designation F1781;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()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers elastomeric flexible hingefinger total joint implants,used with and without metalgrommets in the reconstruction of the metacarpophalangeal(MCP)and proximal interphalangeal(PIP)joints.1.2 This specification excludes those implants that do nothave an across-the-joint elastomeric linkage.The specificationis limited to implants made from one material in a singleone-step molding procedure.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD624 Test Method for Tear Strength of Conventional Vul-canized Rubber and Thermoplastic ElastomersD813 Test Method for Rubber DeteriorationCrack GrowthD1052 Test Method for Measuring Rubber DeteriorationCut Growth Using Ross Flexing ApparatusD2240 Test Method for Rubber PropertyDurometer Hard-nessF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF2038 Guide for Silicone Elastomers,Gels,and Foams Usedin Medical Applications Part IFormulations and Un-cured MaterialsF2042 Guide for Silicone Elastomers,Gels,and Foams Usedin Medical Applications Part IICrosslinking and Fabri-cation2.2 Government Standards:321 CFR 820 Good Manufacturing Practices for MedicalDevicesMIL STD 177A Rubber Products,Terms for Visible De-fects32.3 ISO Standard:4ISO 10993-1 Biological Evaluations of Medical Devices Part 1:Evaluation and testing within a risk managementprocess3.Significance and Use3.1 The prostheses described in this specification are in-tended for use in the proximal interphalangeal(PIP)andmetacarpophalangeal(MCP)joints.4.Classification4.1 ConstrainedA constrained joint prosthesis is used forjoint replacement and prevents dislocation of the prosthesis inmore than one anatomical plane and consists of either a single,flexible,across-the-joint component,or more than one compo-nent linked together or affined.5.Materials and Manufacture5.1 Proper material selection is necessary,but insufficient toensure suitable functioning of a device.All devices conformingto this specification shall be fabricated from materials with1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.22 on Arthroplasty.Current edition approved Oct.1,2015.Published December 2015.Originallyapproved in 1997.Last previous edition approved in 2009 as F1781 03(2009).DOI:10.1520/F1781-15.2For 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.3Available 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.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 adequate mechanical strength,durability and biocompatibility.All elastomeric components shall conform to Guides F2038and F2042.5.2 Test and evaluation parameters that could be consideredfor the elastomeric implant materials are Test Methods D813,D1052,D2240,D412 and D624.Before implants can bemanufactured from other materials,manufacturers shall com-ply with 5.3.5.3 BiocompatibilityFlexible hinge implants shall bemanufactured from the materials listed in 5.2 and 5.3.Beforeimplants can be manufactured from other materials,theirbiocompatibility shall be demonstrated by producing an ac-ceptable response after testing in accordance with PracticesF748 or ISO 10993-1.5.4 Titanium used as a material of construction for metalgrommets shall conform to Specification F67.Metal grommetsshall match the shape of the implant and not interfere with theflexible hinge implant