1、Designation: F86 12aStandard 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 revisio
2、n. 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 surfacec
3、haracteristics, 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 precedenc
4、e 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 Standa
6、rds: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
7、Orthopaedic 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
8、foreign 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 an
9、d 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 shou
10、ld 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 treatm
12、ents 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 foll
13、ow-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 unde
14、r 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 Dec. 1, 2012. Published December 2012. Originallyapproved in 1984. Last previous edition approved in 2012 as
15、 F86 12. DOI:10.1520/F0086-12A.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.*A Summary of Changes section
16、appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.2.2 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
17、.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 mechanic
18、al 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 3Befor
19、e 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.5
20、.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,an
21、odizing, 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 (specificgravity 1.1197 to 1.285) at room temperature for a minimum of30 min. The room temperature passi
22、vation 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 Specification A967 andPractice A380).6.2.1.1 This treatment prov
23、ides 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 des
24、igns 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, and tantalum alloys (see
25、Specification 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 s
26、urface 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 Mark
27、ings 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
28、 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 or labeling on the implan
29、t 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 marking are as follows:7.5
30、.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 characters,7.5.5 Marking with
31、 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 The surfaces of the finishe
32、d 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 inaddition to or instead of unai
33、ded visual examination.9. Keywords9.1 alkaline cleaners; cleaning; electropolishing; final in-spections; markings; metal implants; passivation; surface treat-mentsF86 12a2APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The surface treatment and marking of implants caninfluence the following: loc
34、al 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. Foreign material on the sur
35、faces 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.X1.3 Limited studies hav
36、e 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 thisinformation, it is impera
37、tive 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 fulfillother purposes, some of wh
38、ich 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 experi-mentally. Therefore
39、, 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 F04 has identified the
40、location of selected changes to this standard since the last issue (F86 12)that may impact the use of this standard. (Approved Dec. 1, 2012.)(1) Added titanium to 6.3. (2) Revised 8.1.Committee F04 has identified the location of selected changes to this standard since the last issue (F86 04(2009) th
41、at 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 International takes no posit
42、ion 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 responsibilit
43、y.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 ASTM
44、 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 address s
45、hown 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), 610-8
46、32-9555 (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.F86 12a3
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