ASTM F629-2002(2007) Standard Practice for Radiography of Cast Metallic Surgical Implants.pdf

1、Designation: F 629 02 (Reapproved 2007)Standard Practice forRadiography of Cast Metallic Surgical Implants1This standard is issued under the fixed designation F 629; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 T

3、his 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 Docume

4、nts2.1 ASTM Standards:2E 94 Guide for Radiographic ExaminationE 192 Reference Radiographs of Investment Steel Castingsfor Aerospace ApplicationsE 1030 Test Method for Radiographic Examination of Me-tallic Castings2.2 ASNT Standard:SNT-TC-1A Recommended Practice for Personnel Quali-fication and Certi

5、fication in Nondestructive Testing33. Terminology3.1 For definitions used in this practice, refer to the terms inTest Method E 1030 and Reference Radiographs E 192.4. Significance and Use4.1 The requirements expressed in this practice are intendedto control the quality of the radiographic image of c

6、ast metallicsurgical implants 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 E 1030.5.1.1 Acceptance criteria should be derived from the refer-ence radiographs presented in Re

7、ference Radiographs E 192.5.2 Radiography of cobalt- or iron-base surgical implantcastings may create film images resulting from grain diffrac-tion. Radiographic techniques shall be utilized to ensuredifferentiation between these images and actual indications.5.2.1 Generally, cobalt- or iron-base su

8、rgical 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, andrel

9、atively 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, may helpreduce grain diffraction. Additionally, multiple radiographicex

10、posures in which the radiographic film is moved relative tothe central ray of radiation also helps to change the diffractionpattern.5.3 Radiography of titanium-base surgical implant castingsmay create a general mottled image, however standard low-energy radiation should produce acceptable sensitivit

11、y.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 pro

12、duct acceptance and rejection criteria shall beas agreed upon between the purchaser and supplier; however,indications which are linear in nature, generally, are unaccept-able.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct

13、responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Dec. 1, 2007. Published January 2008. Originallyapproved in 1979. Last previous edition approved in 2002 as F 629 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer

14、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.1Copyrigh

15、t ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7.1.2 The mutually agreed upon acceptance or rejectionlimits shall employ ASTM reference radiographs or otherradiographs, and where feasible, shall identify discontinuity ofsize and type levels.

16、8. Personnel Certification8.1 The personnel performing radiography under this prac-tice shall be certified in accordance with SNT-TC-1A,orrecognized national equivalent.8.1.1 The personnel performing radiographic interpretationshall be certified Level II or Level III individuals, or equiva-lent, in

17、accordance with SNT-TC-1A or equivalent.9. Report9.1 A certified report shall be maintained showing radio-graphic test results including any rejected pieces.9.1.1 Reports and radiographs, or an equivalent image of aradiograph shall be maintained by the purchaser for the life ofthe device.APPENDIX(No

18、nmandatory Information)X1. RATIONALEX1.1 The acceptance criteria for the radiographic examina-tion of cast metallic surgical implants and related weldments isbased on reference radiographs presented in Reference Radio-graphs E 192.X1.2 Specific radiographic techniques have been includedto aid film i

19、mage interpretation and ensure that adequatesensitivity has been maintained.X1.3 Cobalt-, iron-, and titanium-base surgical implantcastings may be radiographically examined according to theprocedures referenced in this practice.ASTM International takes no position respecting the validity of any pate

20、nt 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 subject to revision

21、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 Headquarters. Your comme

22、nts 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

23、 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 serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 629 02 (2007)2