ASTM_F_86_-_13.pdf

Designation:F8613Standard 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.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()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 surfacecharacteristics,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 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 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 Standards: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 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 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 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 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 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 Specific finish requirements such as texture,surfaceroughness,or additional surface treatments 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 follow-ing as appropriate:5.2.1 A method such as organic solvent degreasing for theremoval of oils,greases,and other loose surface contaminants.NOTE1Anhydrous methanol and other solvents known to cause1This practice is 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 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 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 appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 environmentally 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.5.2.2.2 Alkaline cleaner applied electrochemically as rec-ommended.NOTE2Avoid 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 cleaningwil