ASTM F629-97

Standard Practice for Radiography of Cast Metallic Surgical Implants

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

• Replaced By: ASTM F629-02 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• 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 F3055-14a(2021) - Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion
• Effective Date: 10-Apr-2002
• 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• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)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 F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 10-Apr-2002

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 629 – 97
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.
1. Scope castings may create film images resulting from grain diffrac-
tion. Radiographic techniques shall be utilized to ensure
1.1 This practice covers the procedure for radiographic
differentiation between these images and actual indications.
testing of cast metallic surgical implants and related weld-
5.2.1 Generally, cobalt- or iron-base surgical implant cast-
ments.
ings require radiation intensities higher than normal, facilitat-
1.2 This standard does not purport to address all of the
ing reduced exposure times.
safety concerns, if any, associated with its use. It is the
5.2.1.1 Energies between 250 and 400 kV may be required
responsibility of the user of this standard to establish appro-
to radiograph surgical implants with a ⁄2-in. (12.7-mm) mate-
priate safety and health practices and determine the applica-
rial thickness.
bility of regulatory limitations prior to use.
5.2.2 In some instances, filters, at the tube head, and
2. Referenced Documents
relatively thick lead intensifying screens may reduce grain
diffraction while sustaining adequate radiographic sensitivity.
2.1 ASTM Standards:
5.2.3 Multiple radiographic exposures in which the implant
E 94 Guide for Radiographic Testing
is rotated between 5 and 180°, relative to the film, may help
E 142 Method for Controlling Quality of Radiographic
reduce grain diffraction. Additionally, multiple radiographic
Testing
exposures in which the radiographic film is moved relative to
E 192 Reference Radiographs of Investment Steel Castings
the central ray of radiation also helps to change the diffraction
for Aerospace Applications
pattern.
2.2 ASNT Standard:
5.3 Radiography of titanium-base surgical implant castings
SNT-TC-1A Personnel Qualification and Certification in
may create a general mottled image, however standard low-
Nondestructive Testing
energy radiation should produce acceptable sensitivity.
3. Terminology
6. Sensitivity Requirements
3.1 For definitions used in this practice, refer to the terms in
6.1 Sensitivity of surgical implant castings shall be 2-2T,
Guide E 94, Method E 142, and Reference Radiographs E 192.
with the 2T hole clearly discernible, in the area of interest.
4. Significance and Use
7. Metallurgical Requirements
4.1 The requirements expressed in this practice are intended
7.1 In the absence of cast metallic implant standards at this
to control the quality of the radiographic image of cast metallic
time, the following requirements are suggested:
surgical implants and related weldments.
7.1.1 The product acceptance and rejection criteria shall be
5. Radiographic Methods
as agreed upon between the purchaser and supplier; however,
indications which are linear in nature, generally, are unaccept-
5.1 The radiographic method shall be agreed upon between
able.
the purchaser and supplier but should be in accordance with
7.1.2 The mutually agreed upon acceptance or
...