ASTM F629-02

Standard Practice for Radiography of Cast Metallic Surgical Implants

SIGNIFICANCE AND USE
The requirements expressed 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 problems, 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: 09-Apr-2002
• 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 F629-97 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 10-Apr-2002
• Replaced By: ASTM F629-02(2007) - Standard Practice for Radiography of Cast Metallic Surgical Implants
• 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: 10-Apr-2002
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 10-Apr-2002
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 10-Apr-2002
• Referred By: ASTM F3056-14(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion
• Effective Date: 10-Apr-2002
• Referred By: ASTM F1108-21 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2924-14(2021) - Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 10-Apr-2002
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2895-20 - Standard Practice for Digital Radiography of Cast Metallic Implants
• Effective Date: 10-Apr-2002
• Referred By: ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 10-Apr-2002
• Referred By: ASTM F3055-14a(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion
• Effective Date: 10-Apr-2002

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:F629–02
Standard Practice for
1
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.
1. Scope * 5.1.1 Acceptance criteria should be derived from the refer-
ence radiographs presented in Reference Radiographs E 192.
1.1 This practice covers the procedure for radiographic
5.2 Radiography of cobalt- or iron-base surgical implant
testing of cast metallic surgical implants and related weld-
castings may create film images resulting from grain diffrac-
ments.
tion. Radiographic techniques shall be utilized to ensure
1.2 This standard does not purport to address all of the
differentiation between these images and actual indications.
safety concerns, if any, associated with its use. It is the
5.2.1 Generally, cobalt- or iron-base surgical implant cast-
responsibility of the user of this standard to establish appro-
ings require radiation intensities higher than normal, facilitat-
priate safety and health practices and determine the applica-
ing reduced exposure times.
bility of regulatory limitations prior to use.
5.2.1.1 Energies between 250 and 400 kV may be required
1
2. Referenced Documents
to radiograph surgical implants with a ⁄2-in. (12.7-mm) mate-
rial thickness.
2.1 ASTM Standards:
2
5.2.2 In some instances, filters, at the tube head, and
E 94 Guide for Radiographic Examination
relatively thick lead intensifying screens may reduce grain
E 192 Reference Radiographs of Investment Steel Castings
2
diffraction while sustaining adequate radiographic sensitivity.
for Aerospace Applications
5.2.3 Multiple radiographic exposures in which the implant
E 1030 Test Method for Radiographic Examination of Me-
2
is rotated between 5 and 180°, relative to the film, may help
tallic Castings
reduce grain diffraction. Additionally, multiple radiographic
2.2 ASNT Standard:
exposures in which the radiographic film is moved relative to
SNT-TC-1A Recommended Practice for Personnel Quali-
3
the central ray of radiation also helps to change the diffraction
fication and Certification in Nondestructive Testing
pattern.
3. Terminology
5.3 Radiography of titanium-base surgical implant castings
may create a general mottled image, however standard low-
3.1 For definitions used in this practice, refer to the terms in
energy radiation should produce acceptable sensitivity.
Test Method E 1030 and Reference Radiographs E 192.
6. Sensitivity Requirements
4. Significance and Use
6.1 Sensitivity of surgical implant castings shall be 2-2T,
4.1 The requirements expressed in this practice are intended
with the 2T hole clearly discernible, in the area of interest.
to control the quality of the radiographic image of cast metallic
surgical implants and related weldments.
7. Metallurgical Requirements
5. Radiographic Methods
7.1 In the absence of cast metallic implant standards at this
time, the following requirements are suggested:
5.1 The radiographic method shall be agreed upon between
7.1.1 The product acceptance and rejection criteria shall be
the purchaser and supplier but should be in accordance with
as agreed upon between the purchaser and supplier; however,
Test Method E 1030.
indications which are linear in nature, generally, are unaccept-
able.
1
This practi
...