ASTM F983-1986(2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components《整形植入件耐用标志的标准实施规程》.pdf

1、Designation: F 983 86 (Reapproved 2009)Standard Practice forPermanent Marking of Orthopaedic Implant Components1This standard is issued under the fixed designation F 983; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、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 It is common practice for orthopaedic implant manufac-turers to apply permanent identification to implant compo-nents.

3、 In this regard, 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

4、 is recognized, however, 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 deter

5、mine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants3. Methods of Marking3.1 For metallic implants, the procedures described inPractice F86should be followed.3.2 For n

6、onmetallic implants, other methods 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 Orthopae

7、dic implants vary widely in size (for example,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 ma

8、rked practically.4.2 Standard InformationWhere 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 ASTM stan-dards, or both, in addition to or in place of trade names isrecommended,

9、 where applicable.4.2.3 Implant component catalog 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 manufacturerwhic

10、h identify (a) the manufacturer and (b) the material fromwhich 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, indi-cating, f

11、or example, implant size and whether an implant isintended 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 ap

12、proved Aug. 1, 2009. Published September 2009. Originallyapproved in 1986. Last previous edition approved in 2005 as F 983 86(2005).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume inform

13、ation, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The intent of this practice is to provide neededinformation to

14、 users of orthopaedic implants under two differ-ent circumstances. 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 forpositiv

15、e identification of the implants under such circum-stances. 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

16、position respecting the validity of any patent rights asserted 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 responsi

17、bility.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 standardsand should be addressed to

18、 ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the addr

19、ess shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 983 86 (2009)2