ASTM F629-11

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 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.3 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-2011
• 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)e1 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Dec-2011
• Replaced By: ASTM F629-15 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2011
• Referred By: ASTM F3056-14(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2895-20 - Standard Practice for Digital Radiography of Cast Metallic Implants
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 01-Dec-2011
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Dec-2011
• Referred By: ASTM F3055-14a(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Dec-2011
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist 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-2011
• 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-2011
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2924-14(2021) - Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
• Effective Date: 01-Dec-2011

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
Designation: F629 − 11
StandardPractice for
1
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.
1. Scope 3. Terminology
1.1 This practice covers the procedure for radiographic 3.1 For definitions used in this practice, refer to the terms in
Test Method E1030 and Reference Radiographs E192.
testing of cast metallic surgical implants and related weld-
ments.
4. Significance and Use
1.2 The values stated in inch-pound units are to be regarded
as standard. The values given in parentheses are mathematical 4.1 The requirements in this practice are intended to control
conversions to SI units that are provided for information only the quality of the radiographic image of cast metallic surgical
and are not considered standard. implants and related weldments.
1.3 This standard does not purport to address all of the
5. Radiographic Methods
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
5.1 The radiographic method shall be agreed upon between
priate safety and health practices and determine the applica-
the purchaser and supplier but should be in accordance with
bility of regulatory limitations prior to use.
Test Method E1030 and Guide E94.
5.1.1 Acceptance criteria should be derived from the refer-
2. Referenced Documents
ence radiographs presented in Reference Radiographs E192,
2 E1320, or digital reference images E2660 and E2669.
2.1 ASTM Standards:
5.1.2 Digital radiography when agreed upon between pur-
E94 Guide for Radiographic Examination
chaser and supplier shall be performed in accordance with
E192 Reference Radiographs of Investment Steel Castings
Practice F2895.
for Aerospace Applications
E1030 Test Method for Radiographic Examination of Me-
5.2 Radiography of cobalt- or iron-base surgical implant
tallic Castings
castings may create radiographic images resulting from grain
E1320 Reference Radiographs for Titanium Castings
diffraction. Radiographic techniques shall be utilized to ensure
E2660 Digital Reference Images for Investment Steel Cast-
differentiation between these images and actual indications.
ings for Aerospace Applications
5.2.1 Generally, cobalt- or iron-base surgical implant cast-
E2669 Digital Reference Images for Titanium Castings
ings require radiation intensities higher than normal, facilitat-
F2895 Practice for Digital Radiography of Cast Metallic
ing reduced exposure times.
Implants
5.2.1.1 Energies between 250 and 400 kV may be required
2.2 ASNT Standard: 1
to radiograph surgical implants with a ⁄2-in. (12.7-mm) mate-
SNT-TC-1A Recommended Practice for Personnel Qualifi-
rial thickness.
3
cation and Certification in Nondestructive Testing
5.2.2 In some instances, filters, at the tube head, and
relatively thick lead intensifying screens may reduce grain
diffraction while sustaining adequate radiographic sensitivity.
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
5.2.3 Multiple radiographic exposures in which the implant
Surgical Materials and Devices and is the direct responsibility of Subcommittee
is rotated between 5 and 180°, relative to the film or detector,
F04.12 on Metallurgical Materials.
may help reduce grain diffraction.Additionally, multiple radio-
Current edition approved Dec. 1, 2011. Published December 2011. Originally
´1
approved in 1979. Last previous edition approved in 2007 as F629 – 02 (2007) . graphic exposures in which the radiographic film or detector is
DOI: 10.1520/F0629-11.
moved relative to the central ray of radiation also helps to
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
change the diffraction pattern.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
5.3 Radiography of titanium-base surgical implant castings
the ASTM website.
3
may create a general mottled image. However, standard low-
AvailablefromAmericanSocietyforNondestructiveTesting(ASNT),P.O.Box
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org. energy radiation should produce acceptable sensitivity.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F629 − 11
6. Sensitivity Requirements 8. Personnel Certification
6.1 Sensitivity of surgical implant castings shall be 2-2T,
8.1 The personnel performing radiography under this prac-
with the 2T
...

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.
´1
Designation:F629–02 (Reapproved 2007) Designation: F629 – 11
Standard Practice for
1
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.
1
´ 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
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
1.3 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
2.1 ASTM Standards:
E94 Guide for Radiographic Examination
E192 Reference Radiographs of Investment Steel Castings for Aerospace Applications
E1030 Test Method for Radiographic Examination of Metallic CastingsTest Method for Radiographic Examination of Metallic
Castings
E1320 Reference Radiographs for Titanium Castings
E2660 Digital Reference Images for Investment Steel Castings for Aerospace Applications
E2669 Digital Reference Images for Titanium Castings
F2895 Practice for Digital Radiography of Cast Metallic Implants
2.2 ASNT Standard:
3
SNT-TC-1A 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 Test Method E1030 and Reference Radiographs E192.
4. Significance and Use
4.1The4.1 The requirements in this practice are intended to control the quality of the radiographic image of cast metallic
surgical implants and related weldments.
5. Radiographic Methods
5.1The5.1 The radiographic method shall be agreed upon between the purchaser and supplier but should be in accordance with
Test Method E1030 and Guide E94.
5.1.1 Acceptance criteria should be derived from the reference radiographs presented in Reference Radiographs E192, E1320,
or digital reference images E2660 and E2669.
5.2Radiography 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.
1
This practice is under the jurisdiction ofASTM Committee F04 on Medical and 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 approved in 1979. Last previous edition approved in 2002 as F629–02. DOI:
10.1520/F0629-02R07E01.
´1
Current edition approved Dec. 1, 2011. Published December 2011. Originally approved in 1979. Last previous edition approved in 2007 as F629 – 02 (2007) . DOI:
10.1520/F0629-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book ofASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American Society for Nondestructive Testing (ASNT), P.O. Box 28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F629 – 11
5.1.2 Digital radiography when agreed upon between purchaser and supplier shall be performed in accordance with Practice
F2895.
5.2 Radiography of cobalt- or iron-base surgical implant castings may create radiographic 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.
1
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 Inso
...