ASTM F86-2004 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

1、Designation: F 86 04Standard Practice forSurface Preparation and Marking of Metallic SurgicalImplants1This standard is issued under the fixed designation F 86; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revisi

2、on. A number in parentheses indicates the year of last reapproval. A superscriptepsilon (e) 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 surfac

3、e 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 shall take prece

4、dence overrequirements listed in this practice, where appropriate.1.2 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 app

5、lica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2A 380 Practice for Cleaning, Descaling, and Passivation ofStainless Steel Parts, Equipment, and SystemsA 967 Specification for Chemical Passivation Treatmentsfor Stainless Steel PartsB 600 Guide for Descali

6、ng and Cleaning Titanium andTitanium Alloy SurfacesF 983 Practice for Permanent 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,

7、 cobalt, titanium, andtantalum base materials.3.2 Iron particles, ceramic 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 remove

8、d to minimize localized rust formation andsuperficial blemishes.3.3 The various 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 f

9、or an additional implant surface treatmentsuch as secondary passivation in 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 impla

10、nts, when inspected in accordance withthis practice, shall be free of surface 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 S

11、pecific finish requirements such as texture, surfaceroughness, or additional 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 mini

12、mizeforeign material.5.2 The cleaning operations used shall relate to the 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 assist

13、ed cracking of titanium and its alloys should beavoided.5.2.2 A method such as one of the following for the removalof adherent foreign material, if necessary.5.2.2.1 Hot alkaline cleaner used as recommended.1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materia

14、ls and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Oct. 1, 2004. Published October 2004. Originallyapproved in 1984. Last previous edition approved in 2001 as F 86 01.2For referenced ASTM standards, visit the ASTM website, www.as

15、tm.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 appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO

16、Box C700, West Conshohocken, PA 19428-2959, United States.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

17、should be considered to confirmthat acidic cleaning will not affect the mechanical properties of alloyssusceptible to hydrogen contamination effects.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

18、cleaning pro-cesses may be found in Guide B 600.NOTE 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 neu

19、tralizing treatment shall be carried out whereappropriate.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 aresuffici

20、ent 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 implant.6.1.1 Details on marking are found in Practice F 983.6.2 Identify or label metallic implants in a manner t

21、hat willminimize potential impairment of the mechanical 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 im

22、plants. Indicate thelocation of the marking on the manufacturing 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

23、 proce-dure,6.5.3 Marking with a round rotating burr 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,

24、its material, and the type ofmarking method and procedure, 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 Immers

25、e in 20 to 45 volume % nitric acid (specificgravity 1.1197 to 1.285) at room temperature for a minimum of30 min. For an accelerated process, a 20 to 25 % acid solution,heated at 120 to 140F (49 to 60C), may be used for aminimum of 20 min. (See Specification A 967 and PracticeA 380).7.2.1.1 This trea

26、tment 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.7.2.2 Use a neutralizing procedure for p

27、roduct designs inwhich acidic liquid could be trapped.7.2.3 A 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 materi

28、al (see Specifi-cation A 967).7.4 For titanium base materials, electrochemical anodizingprocesses can provide similar passivating and cleaning effectsas the electrochemical polishing procedures have. Alternativeoxidation treatments can render passive surfaces as well.7.5 If alternative surface treat

29、ments for implants are used,these treatments should be specified 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

30、 finished implants, at least represen-tative samples of a production lot, shall be inspected usingvisual examination with the unaided eye (but corrected wherenecessary). Other surface inspection methods may be used inaddition.9. Keywords9.1 alkaline cleaner; cleaning; electropolishing; final inspec-

31、tion; marking; metal implants; passivation; surface treatmentF86042APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The surface treatment and marking of implants caninfluence the following important qualities: local tissue re-sponse, bonding or lack of bonding to tissues as indicated bythe applic

32、ation, and fatigue 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 thecompatibility even

33、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 this practice can

34、 neutralizeendotoxin3,4left on an implant surface, while other passivationtreatments (such as those referenced in Specification A 967)cannot or have not been evaluated. In light of this information,it is imperative the implant manufacturer observe the intendedpurposes of processes specified in this

35、practice, such asdescribed in Section 3, and note that neutralization of endot-oxin is not among them. Many different processes exist thatcan neutralize endotoxin, and fulfill other purposes, some ofwhich have been published.3,4This practice does not currentlyinclude biological contaminants in its s

36、cope.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, they should have surface structure

37、s, 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 (F 86 01)that may impact the us

38、e of this standard. (Approved Oct. 1, 2004.)(1) Revised Scope 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 sta

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42、ommittee 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 obtained by contacting ASTM at the abovead

43、dress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).3Merritt, K., Brown, S. A., Hitchins, V. M., “Ability of Nitric Acid or Acetoneto Inactivate Bacterial Lipopolysaccharide (LPS),” Tra Society for Biomaterials,Vol25, 2002, p. 339.4Hitchins, V. M. and Merritt, K., “Decontaminating Particles Exposed toBacterial Endotoxin (LPS),” J Biomed Mater Res, Vol 46, 1999, pp. 434437.F86043