1、Designation: F629 15Standard 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. A number i
2、n parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This practice covers the procedure for radiographictesting of cast metallic surgical implants and related weld-ments.1.2 The values stated in
3、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 i
4、s 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 Ste
5、el Castingsfor Aerospace ApplicationsE1030 Practice for Radiographic Examination of MetallicCastingsE1320 Reference Radiographs for Titanium CastingsE2660 Digital Reference Images for Investment Steel Cast-ings for Aerospace ApplicationsE2669 Digital Reference Images for Titanium CastingsF2895 Pract
6、ice for Digital Radiography of Cast MetallicImplants2.2 ASNT Standard:3SNT-TC-1A Recommended Practice for Personnel Qualifi-cation and Certification in Nondestructive Testing2.3 AIA/NAS Standard:4NAS410 Certification and Qualification of NondestructiveTest Personnel2.4 CEN Standard:5EN 4179 Aerospac
7、e series Qualification and approval ofpersonnel for non-destructive testing3. 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
8、 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 t
9、he 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 implant
10、castings 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, f
11、acilitat-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 su
12、staining adequate radiographic 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, 2015. Published February 2016. Orig
13、inallyapproved in 1979. Last previous edition approved in 2011 as F629 11. DOI:10.1520/F0629-15.2For 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 Docume
14、nt 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.4Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd.,Suite 1700, Arlington, VA 22209, http:/www.ai
15、a-aerospace.org.5Available from European Committee for Standardization (CEN), AvenueMarnix 17, B-1000, Brussels, Belgium, http:/www.cen.eu.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-29
16、59. United States15.2.3 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
17、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.6. Sensitivity Requirements6.1 Sensitivity of surgical implant castings
18、shall be 2-2T,with the 2T hole clearly discernible.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; h
19、owever,indications which are linear in nature, generally, are unaccept-able.7.1.2 The mutually agreed upon acceptance or rejectionlimits shall employ ASTM reference radiographic images orother radiographic images, and where feasible, shall identifydiscontinuity of size and type levels.8. Personnel C
20、ertification8.1 The personnel performing radiography under this prac-tice shall be certified in accordance with SNT-TC-1A,NAS410, EN 4179, or other internationally recognized equiva-lent society or organization.8.1.1 The personnel performing radiographic interpretationshall be certified Level II or
21、Level III individuals, orequivalent, in accordance with SNT-TC-1A, NAS410, EN4179, or other internationally recognized equivalent society ororganization.9. Report9.1 A certified report shall be maintained showing radio-graphic test results including any rejected pieces.9.1.1 Reports and radiographic
22、 images, or an equivalentimage of a radiograph shall be maintained by the purchaser forthe life of the device.APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The acceptance criteria for the radiographic examina-tion of cast metallic surgical implants and related weldments isbased on reference ra
23、diographs presented in Reference Radio-graphs E192, E1320, or digital reference images of E2660 orE2669.X1.2 Specific radiographic techniques have been includedto aid radiographic image interpretation and ensure that ad-equate sensitivity has been maintained.X1.3 Cobalt-, iron-, and titanium-base su
24、rgical implantcastings may be radiographically examined according to theprocedures referenced in this practice.SUMMARY OF CHANGESCommittee F04.13 has identified the location of selected changes to this standard since the last issue (F62911)that may impact the use of this standard. (Approved Dec. 1,
25、2015.)(1) Section 6.1: Deleted the phrase “in the area of interest.”(2) Section 8.1: Changed wording to be consistent with “E”specifications.(3) Section 8.1.1: Changed wording to be consistent with “E”specifications.F629 152ASTM International takes no position respecting the validity of any patent r
26、ights 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 subject to revision at a
27、ny 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 Headquarters. Your comments
28、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 standard is copyrighted by
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