ASTM_F_629_-_11.pdf

Designation:F62911Standard Practice forRadiography of Cast Metallic Surgical Implants1This standard is issued under the fixed designation F629;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.1.Scope1.1 This practice covers the procedure for radiographictesting of cast metallic surgical implants and related weld-ments.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:2E94 Guide for Radiographic ExaminationE192 Reference Radiographs of Investment Steel Castingsfor Aerospace ApplicationsE1030 Test Method for Radiographic Examination of Me-tallic CastingsE1320 Reference Radiographs for Titanium CastingsE2660 Digital Reference Images for Investment Steel Cast-ings for Aerospace ApplicationsE2669 Digital Reference Images for Titanium CastingsF2895 Practice for Digital Radiography of Cast MetallicImplants2.2 ASNT Standard:SNT-TC-1A Recommended Practice for Personnel Qualifi-cation and Certification in Nondestructive Testing33.Terminology3.1 For definitions used in this practice,refer to the terms inTest Method E1030 and Reference Radiographs E192.4.Significance and Use4.1 The requirements in this practice are intended to controlthe quality of the radiographic image of cast metallic surgicalimplants and related weldments.5.Radiographic Methods5.1 The radiographic method shall be agreed upon betweenthe purchaser and supplier but should be in accordance withTest Method E1030 and Guide E94.5.1.1 Acceptance criteria should be derived from the refer-ence radiographs presented in Reference Radiographs E192,E1320,or digital reference images E2660 and E2669.5.1.2 Digital radiography when agreed upon between pur-chaser and supplier shall be performed in accordance withPractice F2895.5.2 Radiography of cobalt-or iron-base surgical implantcastings may create radiographic images resulting from graindiffraction.Radiographic techniques shall be utilized to ensuredifferentiation between these images and actual indications.5.2.1 Generally,cobalt-or iron-base surgical implant cast-ings require radiation intensities higher than normal,facilitat-ing reduced exposure times.5.2.1.1 Energies between 250 and 400 kV may be requiredto radiograph surgical implants with a12-in.(12.7-mm)mate-rial thickness.5.2.2 In some instances,filters,at the tube head,andrelatively thick lead intensifying screens may reduce graindiffraction while sustaining adequate radiographic sensitivity.5.2.3 Multiple radiographic exposures in which the implantis rotated between 5 and 180,relative to the film or detector,may help reduce grain diffraction.Additionally,multiple radio-graphic exposures in which the radiographic film or detector ismoved relative to the central ray of radiation also helps tochange the diffraction pattern.5.3 Radiography of titanium-base surgical implant castingsmay create a general mottled image.However,standard low-energy radiation should produce acceptable sensitivity.1This 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 Dec.1,2011.Published December 2011.Originallyapproved in 1979.Last previous edition approved in 2007 as F629 02(2007)1.DOI:10.1520/F0629-11.2For 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.3Available fromAmerican Society for Nondestructive Testing(ASNT),P.O.Box28518,1711 Arlingate Ln.,Columbus,OH 43228-0518,http:/www.asnt.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 6.Sensitivity Requirements6.1 Sensitivity of surgical implant castings shall be 2-2T,with the 2T hole clearly discernible,in the area of interest.7.Metallurgical Requirements7.1 In the absence of cast metallic implant standards at thistime,the following requirements are suggested:7.1.1 The product acceptance and rejection criteria shall beas agreed upon between the purchaser and supplier;however,indications which are linear in nature,generally,are unaccept-able.7.1.2 The mutually agreed upon acceptance or rejectionlimits shall employ ASTM