ASTM F86-2004(2009) Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants《金属外科植入物表面制备和标志的标准实施规程》.pdf

1、Designation: F86 04 (Reapproved 2009)Standard 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 yea

2、r of last revision. 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 descri

3、ption of surface charac-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 s

4、hall take precedence 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

5、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 determine the applica-bility of regulatory limitations prior to use.2. Referenced Docum

6、ents2.1 ASTM Standards: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 Perm

7、anent Marking of 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

8、media, and other foreign 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 va

9、rious chemical and 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

10、 nitric acid should 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 surf

11、ace imperfections 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 addition

12、al surface treatments shall be included inthe implant production specification.4.3 The implants shall be given a final surface treatmentaccording to Section 7.5. Cleaning5.1 The surface of the implants shall be cleaned to minimizeforeign material.5.2 The cleaning operations used shall relate to the

13、follow-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

14、under 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, 2009. Published December 2009. Originallyapproved in 1984. Last previous edition approved in 200

15、4 as F86 04. DOI:10.1520/F0086-04R09.2For 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 s

16、ection 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 recom

17、mended.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

18、mechanical 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.NOT

19、E 3Before 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 whereappro

20、priate.5.4 An adequate rinsing operation shall be carried out.5.5 An adequate drying cycle shall follow.6. Product Marking6.1 Markings are applied to the implant surfaces to providetraceability if the size and configuration of the implant aresufficient for such markings. To minimize potential advers

21、eeffects, it is necessary to use an appropriate marking procedureand technique and to select a suitable location for the markingof the implant.6.1.1 Details on marking are found in Practice F983.6.2 Identify or label metallic implants in a manner that willminimize potential impairment of the mechani

22、cal properties orcorrosion resistance and will not elicit adverse tissue response.6.3 Locate the marking 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 m

23、anufacturing drawing of theimplant.6.4 The marking nomenclature shall be documented.6.5 Some methods of marking are as follows:6.5.1 Mechanical imprinting of round-bottom and round-edge characters,6.5.2 Chemical etching using an anodic electrolytic proce-dure,6.5.3 Marking with a round rotating burr

24、 under low-contactpressure,6.5.4 Casting of markings into the surface using round-edgeand round-bottom characters,6.5.5 Marking with vibrator-type contact,6.5.6 Electro-pencil marking, and6.5.7 Marking with laser beam.6.6 Depending on the implant, its material, and the type ofmarking method and proc

25、edure, the marking may be appliedbefore or after the final surface treatment. (See 7.6).7. Final Surface Treatment7.1 Implants shall be given a final surface treatment beforethey are packaged.7.2 Final surface treatments are as follows:7.2.1 Immerse in 20 to 45 volume % nitric acid (specificgravity

26、1.1197 to 1.285) at room temperature for a minimum of30 min. For an accelerated process, a 20 to 25 % acid solution,heated to 120 to 140F (49 to 60C), may be used for aminimum of 20 min. (See Specification A967 and PracticeA380).7.2.1.1 This treatment provides passivation by surface oxi-dation and c

27、an dissolve certain foreign material that might bepresent from previous operations; it is therefore particularlyrecommended when no other treatments that would removesuch foreign material take place.7.2.2 Use a neutralizing procedure for product designs inwhich acidic liquid could be trapped.7.2.3 A

28、 thorough water rinsing process and a drying processare essential.7.3 Alternatively, for stainless steel and cobalt alloys, a finalelectropolishing procedure can provide passive surface condi-tions and cleansing from certain foreign material (see Specifi-cation A967).7.4 For titanium base materials,

29、 electrochemical anodizingprocesses can provide similar passivating and cleaning effectsas the electrochemical polishing procedures. Alternative oxi-dation treatments can provide passive surfaces as well.7.5 If alternative surface treatments for implants are used,these treatments should be specified

30、 in the production proce-dure documentation.7.6 If marking of implants is performed after the finalsurface treatment, it must be evaluated whether a secondarypassivation treatment is necessary or not.8. Inspection8.1 The surfaces of the finished implants, at least represen-tative samples of a produc

31、tion lot, shall be inspected usingvisual examination with the unaided eye (with vision correctedif necessary). Other surface inspection methods may be used inaddition.9. Keywords9.1 alkaline cleaner; cleaning; electropolishing; final inspec-tion; marking; metal implants; passivation; surface treatme

32、ntF86 04 (2009)2APPENDIX(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 indicated by the application, andfatigue strength of implants.X1.2 Local tissue response of met

33、allic 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 thecompatibility even in the absence of corrosion or may affectcontacting implant components. S

34、pecifications 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 this practice can neutralizeendotoxin3,4left on an implant surface, while other passivatio

35、ntreatments (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 processes specified in thispractice, such as described in Section 3, and note that neutr

36、al-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 biological contaminants inits scope.X1.4 The fatigue strength of implants is affected by

37、 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, they should have surface structures, residualstresses, surface treatments, and other charac

38、teristics 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 (F86 01)that may impact the use of this standard. (Approved Oct. 1, 2004.)(1) Revised Sc

39、ope to exclude neutralization of endotoxin.(2) Corrected temperature conversion error in 7.2.1.(3) Added new section X1.3 to Rationale discussing subject ofneutralization of endotoxin by a passivation treatment and thescope of the current standard.ASTM International takes no position respecting the

40、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 responsibility.This standard is

41、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 International Head

42、quarters. 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 shown below.This sta

43、ndard 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 s

44、erviceastm.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 04 (2009)3