ASTM F601-03

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

SIGNIFICANCE AND USE
This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic surgical implants.
The product acceptance and rejection criteria will be as agreed upon between the purchaser and the supplier.
SCOPE
1.1 This practice is intended as a guide for fluorescent penetrant inspection of metallic surgical implants.
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: 09-Sep-2003
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F601-98 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• Effective Date: 10-Sep-2003
• Replaced By: ASTM F601-03(2008) - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• Effective Date: 01-Feb-2008
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 10-Sep-2003
• Referred By: ASTM F1801-20 - Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• Effective Date: 10-Sep-2003
• Referred By: ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• Effective Date: 10-Sep-2003
• Referred By: ASTM F961-20 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
• Effective Date: 10-Sep-2003
• Referred By: ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 10-Sep-2003
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 10-Sep-2003
• Referred By: ASTM F1108-21 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
• Effective Date: 10-Sep-2003
• 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-Sep-2003
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 10-Sep-2003

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:F601–03
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
1
Implants
This standard is issued under the fixed designation F 601; 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* 4.2 The penetrant system used shall conform to a minimum
of Sensitivity Level 3, in accordance with the latest revision of
1.1 This practice is intended as a guide for fluorescent
AMS 2644.
penetrant inspection of metallic surgical implants.
4.3 All penetrant materials shall be compatible with each
1.2 This standard does not purport to address all of the
other.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
5. Penetrant Method Materials Control
priate safety and health practices and determine the applica-
5.1 Thepenetrantmethodmaterialsdeteriorateinusefulness
bility of regulatory limitations prior to use.
through contamination and age. The following controls should
2. Referenced Documents be used to evaluate the materials’ usefulness unless the
supplier’s requirements are more stringent:
2.1 ASTM Standards:
5.1.1 Penetrants:
D 95 Test Method for Water in Petroleum Products and
2
5.1.1.1 Water Content—Where there is a possibility of
Bituminous Materials by Distillation
3
water contamination to penetrant materials, the water content
E 165 Test Method for Liquid Penetrant Examination
should be determined by Test Method D 95. The water content
E 433 Reference Photographs for Liquid Penetrant Inspec-
3
shallnotexceed10 %.Thefrequencyoftestingshallbeatleast
tion
4
once every 30 days for open containers.
2.2 ASNT Recommended Practice:
5.1.1.2 Fluorescent Brightness—Fluorescent brightness
Recommended Practice No. SNT-TC-1A
5
should be determined at least once every 30 days or before use
2.3 SAE Standard:
bycomparisonofsamplesoftheworkingpenetranttoasample
AMS 2644 Inspection Material, Penetrant
of new penetrant under black light. No visible difference shall
3. Significance and Use be allowed.
5.1.2 Developer:
3.1 This practice is intended to confirm the method of
5.1.2.1 Dry—The developer should be dry and fluffy. De-
obtaining and evaluating the fluorescent penetrant indications
velopers showing evidence of fluorescence when compared to
on metallic surgical implants.
new developer shall not be used.
3.2 The product acceptance and rejection criteria will be as
5.1.2.2 Wet—A method should be employed to ensure
agreed upon between the purchaser and the supplier.
adequate suspension of the wet developer prior to use. The
4. Fluorescent Penetrant Method
specificgravityofthedevelopershouldbefrom1.018to1.034.
This method does not apply to nonaqueous solvent developer
4.1 Perform fluorescent penetrant inspection of metallic
due to the volatile nature of the product.
surgical implants in accordance with Practice E 165, Method
5.1.3 Black Lights—Black lights used for fluorescent pen-
A.
etrantinspectionshouldbecheckedforblacklightoutput(with
2
a filter) for a minimum of 800 µW/cm at a distance of 381 mm
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
(15 in.) from the lamp face. This measurement could be
Surgical Materials and Devices and is the direct responsibility of Subcommittee
determined by using a calibrated black light meter. The
F04.12 on Metallurgical Materials.
frequency of testing shall be at least once every 7 days or
Current edition approved Sept. 10, 2003. Published October 2003. Originally
approved in 1978. Last previous edition approved in 1998 as F 601 – 98. before use.
2
Annual Book of ASTM Standards, Vol 05.01.
3
Annual Book of ASTM Standards, Vol 03.03.
6. Evaluation
4
Available fromAmerican Society for Non-Destructive Testing, 3200 Riverside
6.1 A general method of evaluating fluorescent penetrant
Dr., Columbus, OH 43221.
5
Available from Society of Automotive Engineers (SAE), 400 Commonwealth indications is encompassed in Reference Photographs E 433.
Dr., Warrendale, PA 15096-0001.
*A Summary of Changes section appears at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F601–03
7. Personnel Certification 8. Keywords
7.1 The personnel performing fluorescent penetrant inspec-
8.1 fluorescent; penetrant inspection; testing methods; sur-
tion under this practice shall be certified in accordance with
gical implants
ASNT Recommended Practice No. SNT-TC-1A or recognized
national equivalent.
APPENDIX
(Nonmandatory Information)
X1. RATIONALE
X1.1 A me
...