ASTM F983-1986(2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components《矫形外科植入物部件永久性标记的标准实施规程》.pdf

1、Designation: F983 86 (Reapproved 2018)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 la

2、st revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () 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. I

3、n 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 i

4、s 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, health, and environmental pract

5、ices and deter-mine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and

6、 Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.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 inPra

7、ctice F86 should be followed.3.2 For nonmetallic 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 Inc

8、luded in Permanent Marking4.1 Orthopaedic 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 n

9、ot provide any surfaceswhich can be marked 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 ASTMstandards, or both, in addition to or in

10、 place of trade names isrecommended, 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 lett

11、ers selected by the manufacturerwhich 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 t

12、he permanent marking,indicating, for 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

13、 Osteosynthesis.Current edition approved Feb. 1, 2018. Published April 2018. Originallyapproved in 1986. Last previous edition approved in 2013 as F983 86(2013). DOI:10.1520/F0983-86R18.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceas

14、tm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document 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 i

15、nternationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1APPENDIX(Nonmandatory Information)X1. RATION

16、ALEX1.1 The intent of this practice is to provide neededinformation to 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

17、 foruse. Permanent, readily understood marking will provide forpositive 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 resea

18、rchin implant utilization and performance.ASTM International takes no 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 t

19、he 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

20、of this standard or for additional standardsand should be addressed to 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 shoul

21、dmake your views known to the ASTM Committee on Standards, at the address 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 obtain

22、ed 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). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 86 (2018)2