ASTM F86-2012 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants《金属外科植入物表面制备和标记的标准操作规程》.pdf

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1、Designation: F86 12Standard Practice forSurface Preparation and Marking of Metallic SurgicalImplants1This standard is issued under the fixed designation F86; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision

2、. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.1. Scope*1.1 This practice provides a description of surface c

3、harac-teristics, methods of surface preparation, and methods ofmarking for metallic surgical implants. Marking nomenclatureand neutralization of endotoxin are not specified in this practice(see X1.3). Surface requirements and marking methods in-cluded in the implant specification shall take preceden

4、ce overrequirements listed in this practice, where appropriate.1.2 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.1.3 This standard does

5、 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 regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Stand

6、ards:2A380 Practice for Cleaning, Descaling, and Passivation ofStainless Steel Parts, Equipment, and SystemsA967 Specification for Chemical Passivation Treatmentsfor Stainless Steel PartsB600 Guide for Descaling and Cleaning Titanium andTitanium Alloy SurfacesF983 Practice for Permanent Marking of O

7、rthopaedic Im-plant Components3. Significance and Use3.1 The surface treatments documented in this practice areintended to improve the corrosion resistance of metallicsurgical implants manufactured from iron, cobalt, titanium, andtantalum base materials.3.2 Iron particles, ceramic media, and other f

8、oreign particlesmay become smeared over or imbedded into the surface ofimplants during processing operations such as forming, ma-chining, tumbling, bead blasting, and so forth. These particlesshould be removed to minimize localized rust formation andsuperficial blemishes.3.3 The various chemical and

9、 electrochemical surface treat-ments specified in this practice are intended to remove objec-tionable surface contaminants and to restore maximum corro-sion resistance to the passive oxide film.3.4 The need for an additional implant surface treatmentsuch as secondary passivation in nitric acid shoul

10、d be evaluatedfor localized implant surfaces that have electrochemical orlaser product markings created after the final surface treatment.4. Description of Acceptable Surface Characteristics4.1 Metallic implants, when inspected in accordance withthis practice, shall be free of surface imperfections

11、such astoolmarks, nicks, scratches, cracks, cavities, burrs, and otherdefects that would impair the serviceability of the device. Thesurfaces shall be cleaned to minimize the presence of foreignmaterial.4.2 Specific finish requirements such as texture, surfaceroughness, or additional surface treatme

12、nts shall be included inthe implant production specification.4.3 The implants shall be given an appropriate final surfacetreatment according to Section 6.5. Cleaning5.1 The surface of the implants shall be cleaned to minimizeforeign material.5.2 The cleaning operations used shall relate to the follo

13、w-ing as appropriate:5.2.1 A method such as organic solvent degreasing for theremoval of oils, greases, and other loose surface contaminants.NOTE 1Anhydrous methanol and other solvents known to causeenvironmentally assisted cracking of titanium and its alloys should beavoided.1This practice is under

14、 the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved May 15, 2012. Published May 2012. Originallyapproved in 1984. Last previous edition approved in 2009 as F86 0

15、4 (2009). DOI:10.1520/F0086-12.2For 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.1*A Summary of Changes section

16、 appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.2.2 Amethod such as one of the following for the removalof adherent foreign material, if necessary.5.2.2.1 Hot alkaline cleaner used as recommended

17、.5.2.2.2 Alkaline cleaner applied electrochemically as rec-ommended.NOTE 2Avoid cathodic cleaning of metals known to be susceptible tohydrogen contamination and anodic cleaning of metals known to besusceptible to pitting. In addition, testing to confirm that acidic cleaningwill not affect the mechan

18、ical properties of alloys susceptible to hydrogencontamination effects should be considered .5.2.2.3 Ultrasonically agitated cleaning agent.5.2.3 An acidic cleaning process may be used. For titanium,titanium alloys, and tantalum, some possible cleaning pro-cesses may be found in Guide B600.NOTE 3Bef

19、ore an acidic cleaning, degreasing shall be consideredwhere appropriate to make the acidic cleaning effective in a uniformmanner.5.2.3.1 If acidic cleaning methods are used, this shall bestated in the implant production specification.5.3 A neutralizing treatment shall be carried out whereappropriate

20、.5.4 An adequate rinsing operation shall be carried out.5.5 An adequate drying cycle shall follow.6. Final Surface Treatment6.1 Implants shall be given a final surface treatment beforethey are packaged.Anumber of different surface treatments areacceptable, including acid treatment, electropolishing,

21、 anodiz-ing, and oxidation. The following surface treatments should notbe considered restrictive:6.2 Final nitric acid surface treatments are as follows:6.2.1 Immerse in 20 to 45 volume % nitric acid (specificgravity 1.1197 to 1.285) at room temperature for a minimum of30 min. The room temperature p

22、assivation treatment is equiva-lent to the Nitric 2 treatment at 70 to 90F (21 to 32C) inSpecification A967. For an accelerated process, a 20 to 25 %acid solution, heated to 120 to 140F (49 to 60C), may be usedfor a minimum of 20 min. (See SpecificationA967 and PracticeA380).6.2.1.1 This treatment p

23、rovides passivation by surface oxi-dation and is able to dissolve certain foreign material thatmight be present from previous operations; it is thereforeparticularly recommended when no other treatments take placethat would remove such foreign material.6.2.2 Use a neutralizing procedure for product

24、designs inwhich acidic liquid could be trapped.6.2.3 A thorough water rinsing process and a drying processare essential.6.3 A final electropolishing procedure can provide passivesurface conditions and cleansing from certain foreign materialfor stainless steel, cobalt, and tantalum alloys (see Specif

25、ica-tion A967).6.4 Electrochemical anodizing processes for titanium andtantalum base materials can provide similar passivating andcleaning effects as the electrochemical polishing procedureshave. Alternative oxidation treatments can render passivesurfaces as well.6.5 If acceptable alternative surfac

26、e treatments for implantsare used, these treatments should be specified in the productionprocedure documentation.6.6 If marking of implants is performed after the finalsurface treatment, it must be evaluated whether a secondarypassivation treatment is necessary or not.7. Product Marking7.1 Markings

27、are applied to the implant surfaces to providetraceability if the size and configuration of the implant aresufficient for such markings. To minimize potential adverseeffects, it is necessary to use an appropriate marking procedureand technique and to select a suitable location for the markingof the

28、implant.7.1.1 Details on marking are found in Practice F983.7.2 Identify or label metallic implants in a manner that willminimize potential impairment of the mechanical properties orcorrosion resistance and will not elicit adverse tissue response.7.3 Locate the marking or labeling on the implant at

29、a pointof low stress in such a manner as not to intersect the edges ofdrilled holes, countersinks, or edges of implants. Indicate thelocation of the marking on the manufacturing drawing of theimplant.7.4 The marking nomenclature shall be documented.7.5 Some methods of marking are as follows:7.5.1 Me

30、chanical imprinting of round-bottom and round-edge characters,7.5.2 Chemical etching using an anodic electrolytic proce-dure,7.5.3 Marking with a round rotating burr under low-contactpressure,7.5.4 Casting of markings into the surface using round-edgeand round-bottom characters,7.5.5 Marking with vi

31、brator-type contact,7.5.6 Electro-pencil marking, and7.5.7 Marking with laser beam.7.6 Depending on the implant, its material, and the type ofmarking method and procedure, the marking may be appliedbefore or after the final surface treatment. (See 6.6).8. Inspection8.1 The surfaces of the finished i

32、mplants, at least of repre-sentative samples from a production lot, shall be inspectedusing visual examination with the unaided eye (with visioncorrected if necessary). Other surface inspection methods maybe used in addition to or instead of visual examination.9. Keywords9.1 alkaline cleaners; clean

33、ing; electropolishing; final in-spections; markings; metal implants; passivation; surfacetreatmentsF86122APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The surface treatment and marking of implants caninfluence the following: local tissue response, bonding or lackof bonding to tissues as indica

34、ted by the application, andfatigue strength of implants.X1.2 Local tissue response of metallic implants is affectedby corrosion that, in turn, may be affected by embedded foreignparticles and other factors. Foreign material on the surfaces asa result of manufacturing operations may jeopardize thecom

35、patibility even in the absence of corrosion or may affectcontacting implant components. Specifications and control ofsurface characteristics to inhibit local undesirable tissue re-sponse are therefore required.X1.3 Limited studies have indicated the nitric acid passi-vation treatments specified in t

36、his practice can neutralizeendotoxin3,4left on an implant surface, while other passivationtreatments (such as those referenced in Specification A967)cannot or have not been evaluated for this. In light of thisinformation, it is imperative that the implant manufacturerobserve the intended purposes of

37、 processes specified in thispractice, such as described in Section 3, and note that neutral-ization of endotoxin is not among them. There are manydifferent processes that can neutralize endotoxin, and fulfillother purposes, some of which have been published.3,4Thispractice does not currently include

38、 biological contaminants inits scope.X1.4 The fatigue strength of implants is affected by thetopography of the surfaces, residual stresses, and structure. Thefatigue strength of a component may be determined experi-mentally. Therefore, to evaluate or test the fatigue strength offinished implants, th

39、ey should have surface structures, residualstresses, surface treatments, and other characteristics that arerepresentative of the manufacturing process by which theimplant is produced.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue

40、 (F86 04(2009) that may impact the use of this standard. (Approved May 15, 2012.)(1) Swapped the order of the Final Surface Treatment andProduct Marking sections so all surface treatment informationis contiguous.(2) Added the possibility of alternative inspection methods inSection 8.ASTM Internation

41、al 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 the riskof infringement of such rights, are entirely their

42、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 standardsand should be

43、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 shouldmake your views known to the ASTM Committee on Standards,

44、 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 obtained by contacting ASTM at the aboveaddress or at 610-832-95

45、85 (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 ASTM website (www.astm.org/COPYRIGHT/).3Merritt, K., Brown, S. A., Hitchins, V. M., “Ability of Nitric Acid or Acetoneto Inactivate Bacterial Lipopolysaccharide (LPS),” Tra Society for Biomaterials,Vol 25, 2002, p. 339.4Hitchins, V. M. and Merritt, K., “Decontaminating Particles Exposed toBacterial Endotoxin (LPS),” J Biomed Mater Res, Vol 46, 1999, pp. 434437.F86123