ASTM F629-2011 Standard Practice for Radiography of Cast Metallic Surgical Implants《铸造金属外科植入物放射照相的标准操作规程》.pdf

1、Designation: F629 11Standard 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. Scope1.1 This practice covers the procedure for radiographictesting of cast metallic surgical implants and related weld-ments.1.2 The values stated in i

3、nch-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

4、 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 Stee

5、l 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 P

6、ractice for Digital Radiography of Cast MetallicImplants2.2 ASNT Standard:SNT-TC-1A Recommended Practice for Personnel Quali-fication and Certification in Nondestructive Testing33. Terminology3.1 For definitions used in this practice, refer to the terms inTest Method E1030 and Reference Radiographs

7、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

8、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

9、 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 General

10、ly, 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, filter

11、s, 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

12、. Additionally, multiple radio-graphic exposures in which the radiographic film or detector is1This 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 a

13、pproved 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 ASTM

14、Standards 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box

15、 C700, West Conshohocken, PA 19428-2959, United States.moved 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 accept

16、able sensitivity.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 suggeste

17、d: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 reference radiographic images o

18、rother radiographic images, and where feasible, shall identifydiscontinuity of size 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

19、radiographic interpretationshall be certified Level II or Level III individuals, or equiva-lent, in 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 radiographic images, or a

20、n 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 radiographs pre

21、sented 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 surgical implan

22、tcastings may be radiographically examined according to theprocedures referenced in this practice.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 determ

23、ination 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 any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or w

24、ithdrawn. Your comments are invited either for revision of this standard or for additional 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

25、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 ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (s

26、ingle 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F629 112