1、Designation:F98386(Reapproved 2013)Standard Practice forPermanent Marking of Orthopaedic Implant Components1This standard is issued under the fixed designation F983;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last rev
2、ision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 It is common practice for orthopaedic implant manufac-turers to apply permanent identification to implant compo-nents.In this regard,
3、Practice F86 describes recommendedlocations and methods of marking for metallic implants.1.2 The purpose of this practice is to(1)recommend thatorthopaedic implants be permanently marked,and(2)recom-mend practical amounts of information that should be includedin the marking.It is recognized,however,
4、that marking is notpractical in some cases(see 4.1).1.3 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 and health practices and determine the applica-bility of re
5、gulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F86 Practice for Surface Preparation and Marking of Metal-lic Surgical Implants3.Methods of Marking3.1 For metallic implants,the procedures described inPractice F86 should be followed.3.2 For nonmetallic implants,other metho
6、ds should bedevised and utilized.3.3 In any case,however,the marking method should(a)not compromise implant performance significantly,and(b)provide legibility over the anticipated service life of theimplant.4.Information Included in Permanent Marking4.1 Orthopaedic implants vary widely in size(for e
7、xample,from wire to total joint prostheses),and the amount ofinformation that practically can be included in marking variesaccordingly.Some implants,such as threaded pins and cerclagewire and very small bone screws,do not provide any surfaceswhich can be marked practically.4.2 Standard InformationWh
8、ere implant size and shapeallow,it is recommended that the following information beincluded in permanent marking:4.2.1 Manufacturer:4.2.2 MaterialThe use of generic names or ASTMstandards,or both,in addition to or in place of trade names isrecommended,where applicable.4.2.3 Implant component catalog
9、 number or model number.4.2.4 Implant component serial number or lot number.4.3 Minimum InformationWhere implant size and shapeallow,it is recommended that the manufacturer mark smallerimplants with symbols or letters selected by the manufacturerwhich identify(a)the manufacturer and(b)the material f
10、romwhich the component is made.The system of symbols or lettersshould be described in the manufacturers product literature.4.4 Optional InformationManufacturers may wish to in-clude additional information in the permanent marking,indicating,for example,implant size and whether an implant isintended
11、for right limb or left limb reconstruction.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Current edition approved Oct.1,2013.Published October 2013.Originallyapproved
12、 in 1986.Last previous edition approved in 2009 as F983 86(2009).DOI:10.1520/F0983-86R13.2For 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 p
13、age onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 APPENDIX(Nonmandatory Information)X1.RATIONALEX1.1 The intent of this practice is to provide neededinformation to users of orthopaedic implants under two differ-ent ci
14、rcumstances.First,many implants are removed from theirpackages outside the operating room long before surgery takesplace,so that they may be sterilized or otherwise prepared foruse.Permanent,readily understood marking will provide forpositive identification of the implants under such circum-stances.
15、Second,when an implant is surgically removed,positive identification is desirable information for deciding thecourse of subsequent patient care and for purposes of researchin implant utilization and performance.ASTM International takes no position respecting the validity of any patent rights asserte
16、d in connection with any item mentionedin this standard.Users of this standard are expressly advised that determination of the validity of any such patent rights,and the riskof infringement of such rights,are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised,either reapproved or withdrawn.Your comments are invited either for revision of this standard or for additional s
