Radiography of Cast Metallic Surgical Implants: Standard Practice For

Designation: F629 – 02 (Reapproved 2007)´1
Standard Practice for

Radiography of Cast Metallic Surgical Implants1
This standard is issued under the fixed designation F629; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
´1 NOTE—Subsections 4.1, 5.1, and 5.3 were editorially corrected in March 2008.
1. Scope 5. Radiographic Methods

1.1 This practice covers the procedure for radiographic 5.1 The radiographic method shall be agreed upon between
testing of cast metallic surgical implants and related weld- the purchaser and supplier but should be in accordance with
ments. Test Method E1030 and Guide E94.
1.2 This standard does not purport to address all of the 5.1.1 Acceptance criteria should be derived from the refer-
safety concerns, if any, associated with its use. It is the ence radiographs presented in Reference Radiographs E192.
responsibility of the user of this standard to establish appro- 5.2 Radiography of cobalt- or iron-base surgical implant
priate safety and health practices and determine the applica- castings may create film images resulting from grain diffrac-
bility of regulatory limitations prior to use. tion. Radiographic techniques shall be utilized to ensure
differentiation between these images and actual indications.
2. Referenced Documents 5.2.1 Generally, cobalt- or iron-base surgical implant cast-
2.1 ASTM Standards:2 ings require radiation intensities higher than normal, facilitat-
E94 Guide for Radiographic Examination ing reduced exposure times.
E192 Reference Radiographs of Investment Steel Castings 5.2.1.1 Energies between 250 and 400 kV may be required
for Aerospace Applications to radiograph surgical implants with a 1⁄2-in. (12.7-mm) mate-
E1030 Test Method for Radiographic Examination of Me- rial thickness.
tallic Castings 5.2.2 In some instances, filters, at the tube head, and
2.2 ASNT Standard: relatively thick lead intensifying screens may reduce grain
SNT-TC-1A Recommended Practice for Personnel Quali- diffraction while sustaining adequate radiographic sensitivity.
fication and Certification in Nondestructive Testing3 5.2.3 Multiple radiographic exposures in which the implant
is rotated between 5 and 180°, relative to the film, may help
3. Terminology reduce grain diffraction. Additionally, multiple radiographic
3.1 For definitions used in this practice, refer to the terms in exposures in which the radiographic film is moved relative to
Test Method E1030 and Reference Radiographs E192. the central ray of radiation also helps to change the diffraction
pattern.
4. Significance and Use 5.3 Radiography of titanium-base surgical implant castings
4.1 The requirements in this practice are intended to control may create a general mottled image. However, standard low-
the quality of the radiographic image of cast metallic surgical energy radiation should produce acceptable sensitivity.
implants and related weldments.
6. Sensitivity Requirements
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
6.1 Sensitivity of surgical implant castings shall be 2-2T,
Surgical Materials and Devices and is the direct responsibility of Subcommittee with the 2T hole clearly discernible, in the area of interest.
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2007. Published January 2008. Originally 7. Metallurgical Requirements
approved in 1979. Last previous edition approved in 2002 as F629 – 02. DOI:
10.1520/F0629-02R07E01.
7.1 In the absence of cast metallic implant standards at this
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or time, the following requirements are suggested:
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 7.1.1 The product acceptance and rejection criteria shall be
Standards volume information, refer to the standard’s Document Summary page on as agreed upon between the purchaser and supplier; however,
the ASTM website.
3
Available from American Society for Nondestructive Testing (ASNT), P.O. Box indications which are linear in nature, generally, are unaccept-
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org. able.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
F629 – 02 (2007)´1
7.1.2 The mutually agreed upon acceptance or rejection 9. Report
limits shall employ ASTM reference radiographs or other
9.1 A certified report shall be maintained showing radio-
radiographs, and where feasible, shall identify discontinuity of
graphic test results including any rejected pieces.
size and type levels.
9.1.1 Reports and radiographs, or an equivalent image of a
8. Personnel Certification radiograph shall be maintained by the purchaser for the life of
8.1 The personnel performing radiography under this prac- the device.
tice shall be certified in accordance with SNT-TC-1A, or
recognized national equivalent.
8.1.1 The personnel performing radiographic interpretation
shall be certified Level II or Level III individuals, or equiva-
lent, in accordance with SNT-TC-1A or equivalent.
APPENDIX
(Nonmandatory Information)
X1. RATIONALE
X1.1 The acceptance criteria for the radiographic examina- to aid film image interpretation and ensure that adequate
tion of cast metallic surgical implants and related weldments is sensitivity has been maintained.
based on reference radiographs presented in Reference Radio-
graphs E192. X1.3 Cobalt-, iron-, and titanium-base surgical implant
castings may be radiographically examined according to the
X1.2 Specific radiographic techniques have been included procedures referenced in this practice.
ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned
in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk
of 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 and
if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards
and should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of the
responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should
make 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 (single or multiple copies) of this standard may be obtained by contacting ASTM at the above
address or at 610-832-9585 (phone), 610-832-9555 (fax), or service@astm.org (e-mail); or through the ASTM website
(www.astm.org).

Radiography of Cast Metallic Surgical Implants: Standard Practice For

Uploaded by

Copyright:

Available Formats

Radiography of Cast Metallic Surgical Implants: Standard Practice For

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Radiography of Cast Metallic Surgical Implants: Standard Practice For

Uploaded by

Copyright:

Available Formats

Designation: F629 – 02 (Reapproved 2007)´1

Standard Practice for

1. Scope 5. Radiographic Methods

You might also like