ASTM F86-2013 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实施规程》.pdf

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1、Designation: F86 13Standard 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 surfacech

3、aracteristics, 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 precedence

4、 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 n

5、ot 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 Standar

6、ds:2A380 Practice for Cleaning, Descaling, and Passivation ofStainless Steel Parts, Equipment, and SystemsA967 Specification for Chemical Passivation Treatments forStainless Steel PartsB600 Guide for Descaling and Cleaning Titanium and Tita-nium 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,machining, tumbling, bead blasting, and so forth. These par-ticles should be removed to minimize localized rust formationand superficial 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 cause1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and De

14、vices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved June 1, 2013. Published July 2013. Originally approvedin 1984. Last previous edition approved in 2012 as F86 12a. DOI: 10.1520/F0086-13.2For referenced ASTM standards, visit the ASTM webs

15、ite, 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.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor D

16、rive, PO Box C700, West Conshohocken, PA 19428-2959. United States1environmentally assisted cracking of titanium and its alloys should beavoided.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.5.2.2

17、.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 mechanical p

18、roperties 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 3Before an

19、 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.5.4 A

20、n 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,anodiz

21、ing, and oxidation. The following surface treatmentsshould not be considered restrictive:6.2 Final nitric acid surface treatments are as follows:6.2.1 Immerse in 20 to 45 volume % nitric acid at roomtemperature for a minimum of 30 min. The room temperaturepassivation treatment is equivalent to the N

22、itric 2 treatment ata temperature range from 70 to 90F (21 to 32C) in Specifi-cation A967. For an accelerated process, a 20 to 25 volume %acid solution, heated at a temperature in the range from 120 to140F (49 to 60C), may be used for a minimum of 20 min.(See Specification A967 and Practice A380).6.

23、2.1.1 This treatment provides 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

24、procedure for product 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, titanium,

25、 and tantalum alloys (seeSpecification 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

26、 acceptable alternative surface 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

27、. Product Marking7.1 Markings 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 l

28、ocation for the markingof the 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

29、or labeling on the implant at 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 m

30、arking are as follows:7.5.1 Mechanical imprinting of round-bottom and round-edge characters,7.5.2 Chemical etching using an anodic electrolyticprocedure,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 char

31、acters,7.5.5 Marking with vibrator-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 Th

32、e surfaces of the finished implants, 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 atleast as selective as unaided visual examination may be used inaddit

33、ion to or instead of unaided visual examination.9. Keywords9.1 alkaline cleaners; cleaning; electropolishing; final in-spections; markings; metal implants; passivation; surface treat-mentsF86132APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The surface treatment and marking of implants caninflu

34、ence the following: local tissue response, bonding or lackof bonding to tissues as indicated 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. Fore

35、ign material on the surfaces asa result of manufacturing operations may jeopardize thecompatibility 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.X

36、1.3 Limited studies have indicated the nitric acid passiva-tion treatments specified in this 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 thisin

37、formation, it is imperative that the implant manufacturerobserve the intended purposes of 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 fulfilloth

38、er purposes, some of which have been published.3,4Thispractice does not currently include 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 exp

39、eri-mentally. Therefore, to evaluate or test the fatigue strength offinished implants, they should have surface structures, residualstresses, surface treatments, and other characteristics that arerepresentative of the manufacturing process by which theimplant is produced.SUMMARY OF CHANGESCommittee

40、F04 has identified the location of selected changes to this standard since the last issue (F86 12a)that may impact the use of this standard. (Approved June 1, 2013.)(1) Removed incorrect nitric acid specific gravity wording.ASTM International takes no position respecting the validity of any patent r

41、ights 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 responsibility.This standard is subject to revision at a

42、ny 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 ASTM International Headquarters. Your comments

43、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 address shown below.This standard is copyrighted by

44、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);

45、 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.F86133