ASTM F629-02(2007)e1

Standard Practice for Radiography of Cast Metallic Surgical Implants

SIGNIFICANCE AND USE
The requirements in this practice are intended to control the quality of the radiographic image of cast metallic surgical implants and related weldments.
SCOPE
1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Nov-2007
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F629-02(2007) - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Dec-2007
• Replaced By: ASTM F629-11 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Dec-2011
• Referred By: ASTM F1108-21 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Dec-2007
• Referred By: ASTM F3055-14a(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2895-20 - Standard Practice for Digital Radiography of Cast Metallic Implants
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2007
• Referred By: ASTM F75-23 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
• Effective Date: 01-Dec-2007
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-Dec-2007
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Dec-2007
• Referred By: ASTM F2924-14(2021) - Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
• Effective Date: 01-Dec-2007
• Referred By: ASTM F3056-14(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion
• Effective Date: 01-Dec-2007
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Dec-2007

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation:F629–02 (Reapproved 2007)
Standard Practice for
Radiography of Cast Metallic Surgical Implants
ThisstandardisissuedunderthefixeddesignationF629;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
´ 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: 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 ⁄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 Testing
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
6.1 Sensitivity of surgical implant castings shall be 2-2T,
ThispracticeisunderthejurisdictionofASTMCommittee F04onMedicaland
with the 2T hole clearly discernible, in the area of interest.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2007. Published January 2008. Originally 7. Metallurgical Req
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
e1
Designation:F629–97 Designation: F 629 – 02 (Reapproved 2007)
Standard Practice for
Radiography of Cast Metallic Surgical Implants
This standard is issued under the fixed designation F 629; 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 (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Subsections 4.1, 5.1, and 5.3 were editorially corrected in March 2008.
1. Scope
1.1 This practice covers the procedure for radiographic testing of cast metallic surgical implants and related weldments.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2.1 ASTM Standards:
E 94Guide for Radiographic Testing
E142Method for Controlling Quality of Radiographic Testing Guide for Radiographic Examination
E 192Reference Radiographs of Investment Steel Castings forAerospaceApplications Reference Radiographs of Investment
Steel Castings for Aerospace Applications
E 1030 Test Method for Radiographic Examination of Metallic Castings
2.2 ASNT Standard:
SNT-TC-1A Personnel Qualification and Certification in Nondestructive Testing Recommended Practice for Personnel
Qualification and Certification in Nondestructive Testing
3. Terminology
3.1 For definitions used in this practice, refer to the terms in Guide E94, Test Method E142E 1030, and Reference Radiographs
E 192.
4. Significance and Use
4.1 The requirements expressed in this practice are intended to control the quality of the radiographic image of cast metallic
surgical implants and related weldments.
5. Radiographic Methods
5.1 The radiographic method shall be agreed upon between the purchaser and supplier but should be in accordance with Guide
E94Test Method E 1030 and Method E142Guide E 94.
5.1.1 Acceptance criteria should be derived from the reference radiographs presented in Reference Radiographs E 192.
5.2 Radiography of cobalt- or iron-base surgical implant castings may create film images resulting from grain diffraction.
Radiographic techniques shall be utilized to ensure differentiation between these images and actual indications.
5.2.1 Generally, cobalt- or iron-base surgical implant castings require radiation intensities higher than normal, facilitating
reduced exposure times.
5.2.1.1 Energies between 250 and 400 kV may be required to radiograph surgical implants with a ⁄2-in. (12.7-mm) material
thickness.
5.2.2 Insomeinstances,filters,atthetubehead,andrelativelythickleadintensifyingscreensmayreducegraindiffractionwhile
sustaining adequate radiographic sensitivity.
This practice is under the jurisdiction of ASTM Committee F-4F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved April 10, 1997.Dec. 1, 2007. Published March 1998.January 2008. Originally published as F629–79.approved in 1979. Last previous edition
F629–86(1992).approved in 2002 as F 629 – 02.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book ofASTM Standards
, Vol 03.03.volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American Society for Non-Destructive Testin
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