ASTM F629-2002 Standard Practice for Radiography of Cast Metallic Surgical Implants《铸造金属外科植入物X光照相的标准实施规范》.pdf

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1、Designation: F 629 02Standard 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 revision. A number

2、 in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 This standard doe

3、s 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 Stan

4、dards:E 94 Guide for Radiographic Examination2E 192 Reference Radiographs of Investment Steel Castingsfor Aerospace Applications2E 1030 Test Method for Radiographic Examination of Me-tallic Castings22.2 ASNT Standard:SNT-TC-1A Recommended Practice for Personnel Quali-fication and Certification in No

5、ndestructive 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 cast metallicsu

6、rgical 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 Reference Radiog

7、raphs 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 surgical implant

8、 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

9、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 radiographicexposures in whi

10、ch 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 sensitivity.6. Sensitivi

11、ty 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 acceptanc

12、e 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 reference radiographs or otherradiographs, and where feasibl

13、e, shall identify discontinuity ofsize and type levels.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 certifie

14、d Level II or Level III individuals, or equiva-lent, in accordance with SNT-TC-1A or equivalent.1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current editio

15、n approved Apr. 10, 2002. Published June 2002. Originallypublished as F 629 79. Last previous edition F 629 97.2Annual Book of ASTM Standards, Vol 03.03.3Available from American Society for Non-Destructive Testing, P.O. Box 28518,1711 Arlingate Ln., Columbus, OH 43228-0518.1*A Summary of Changes sec

16、tion appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.9. Report9.1 A certified report shall be maintained showing radio-graphic test results including any rejected pieces.9.1.1 Reports and radiograph

17、s, or an equivalent image of aradiograph shall be maintained by the purchaser for the life ofthe 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 radiogra

18、phs presented in Reference Radio-graphs E 192.X1.2 Specific radiographic techniques have been includedto aid film image interpretation and ensure that adequatesensitivity has been maintained.X1.3 Cobalt-, iron-, and titanium-base surgical implantcastings may be radiographically examined according to

19、 theprocedures referenced in this practice.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 629 97)which may impact the use of this standard.(1) Removed references to obsolete Method E 142. (2) Added new references to Test Metho

20、d E 1030.ASTM International takes no position respecting the validity of any patent 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 ri

21、ghts, are entirely their own responsibility.This standard is subject to revision 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 additiona

22、l standardsand should be addressed to ASTM International Headquarters. Your comments 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 AST

23、M Committee 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 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 6292