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.

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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(Reapproved 2008)
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
Implants
ThisstandardisissuedunderthefixeddesignationF601;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* 4. Fluorescent Penetrant Method
1.1 This practice is intended as a guide for fluorescent
4.1 Perform fluorescent penetrant inspection of metallic
penetrant inspection of metallic surgical implants. surgical implants in accordance with Practice E165, MethodA.
1.2 This standard does not purport to address all of the
4.2 The penetrant system used shall conform to a minimum
safety concerns, if any, associated with its use. It is the
of Sensitivity Level 3, in accordance with the latest revision of
responsibility of the user of this standard to establish appro-
AMS 2644.
priate safety and health practices and determine the applica-
4.3 All penetrant materials shall be compatible with each
bility of regulatory limitations prior to use.
other.
2. Referenced Documents
5. Penetrant Method Materials Control
2.1 ASTM Standards:
5.1 Thepenetrantmethodmaterialsdeteriorateinusefulness
D95 Test Method for Water in Petroleum Products and
through contamination and age. The following controls should
Bituminous Materials by Distillation
be used to evaluate the materials’ usefulness unless the
E165 Practice for Liquid Penetrant Examination for General
supplier’s requirements are more stringent:
Industry
5.1.1 Penetrants:
E433 Reference Photographs for Liquid Penetrant Inspec-
5.1.1.1 WaterContent—Wherethereisapossibilityofwater
tion
3 contamination to penetrant materials, the water content should
2.2 ASNT Recommended Practice:
be determined by Test Method D95. The water content shall
Recommended Practice No. SNT-TC-1A
notexceed10 %.Thefrequencyoftestingshallbeatleastonce
2.3 SAE Standard:
every 30 days for open containers.
AMS 2644 Inspection Material, Penetrant
5.1.1.2 Fluorescent Brightness—Fluorescent brightness
should be determined at least once every 30 days or before use
3. Significance and Use
bycomparisonofsamplesoftheworkingpenetranttoasample
3.1 This practice is intended to confirm the method of
of new penetrant under black light. No visible difference shall
obtaining and evaluating the fluorescent penetrant indications
be allowed.
on metallic surgical implants.
5.1.2 Developer:
3.2 The product acceptance and rejection criteria will be as 5.1.2.1 Dry—The developer should be dry and fluffy. De-
agreed upon between the purchaser and the supplier. velopers showing evidence of fluorescence when compared to
new developer shall not be used.
5.1.2.2 Wet—A method should be employed to ensure ad-
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
equate suspension of the wet developer prior to use. The
Surgical Materials and Devices and is the direct responsibility of Subcommittee
specificgravityofthedevelopershouldbefrom1.018to1.034.
F04.12 on Metallurgical Materials.
This method does not apply to nonaqueous solvent developer
Current edition approved Feb. 1, 2008. Published May 2008. Originally
approved in 1978. Last previous edition approved in 2003 as F601 – 03. DOI: due to the volatile nature of the product.
10.1520/F0601-03R08.
5.1.3 Black Lights—Black lights used for fluorescent pen-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
etrantinspectionshouldbecheckedforblacklightoutput(with
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
a filter) for a minimum of 800 µW/cm at a distance of 381 mm
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
(15 in.) from the lamp face. This measurement could be
AvailablefromAmericanSocietyforNondestructiveTesting(ASNT),P.O.Box
determined by using a calibrated black light meter. The
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org.
frequency of testing shall be at least once every 7 days or
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
Dr., Warrendale, PA 15096-0001, http://www.sae.org. before use.
*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
F601 − 03 (2008)
6. Evaluation 8. Keywords
6.1 A general method of eval
...


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.
Designation:F601–98 Designation: F 601 – 03 (Reapproved 2008)
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
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*
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.
2. Referenced Documents
2.1 ASTM Standards:
D 95 Test Method for Water in Petroleum Products and Bituminous Materials by Distillation
E 165 Test Method for Liquid Penetrant Examination
E 433 Reference Photographs for Liquid Penetrant Inspection
2.2 ASNT Recommended Practice:
Recommended Practice No. SNT-TC-1A
2.3 Military Standard:
2.3 SAE Standard:
MIL-I-25135
AMS 2644 Inspection Material, Penetrant
3. Significance and Use
3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic
surgical implants.
3.2 The product acceptance and rejection criteria will be as agreed upon between the purchaser and the supplier.
4. Fluorescent Penetrant Method
4.1 Perform fluorescent penetrant inspection of metallic surgical implants in accordance with Practice E 165, Method A.
4.2 The penetrant system used shall conform to a minimum of Sensitivity Level 3, in accordance with the latest revision of
MIL-I-25135AMS 2644.
4.3 All penetrant materials shall be compatible with each other.
5. Penetrant Method Materials Control
5.1 The penetrant method materials deteriorate in usefulness through contamination and age. The following controls should be
used to evaluate the materials’ usefulness unless the supplier’s requirements are more stringent:
5.1.1 Penetrants:
5.1.1.1 Water Content— Where there is a possibility of water contamination to penetrant materials, the water content should
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 October 10, 1998.Feb. 1, 2008. Published March 1999.May 2008. Originally published as F601–78.approved in 1978. Last previous edition
F601–92.approved in 2003 as F 601 – 03.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. ForAnnualBookofASTMStandards
, Vol 05.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Annual Book of ASTM Standards, Vol 03.03.
Available from American Society for Nondestructive Testing (ASNT), P.O. Box 28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org.
Available from American Society for Non-Destructive Testing, 3200 Riverside Dr., Columbus, OH 43221.
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http://www.sae.org.
*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.
F 601 – 03 (2008)
be determined byTest Method D 95.The water content shall not exceed 10 %.The frequency of testing shall be at least once every
30 days for open containers.
5.1.1.2 Fluorescent Brightness—Fluorescent brightness should be determined at least once every 30 days or before use by
comparison of samples of the working penetrant to a sample of new penetrant under black light. No visible difference shall be
allowed.
5.1.2 Developer:
5.1.2.1 Dry—The developer should be dry and fluffy. Developers showing evidence of fluorescence when compared to new
developer shall not be used.
5.1.2.2 Wet—Amethod should be employed to assureensure adequate suspension of the wet developer prior to use.The specific
gravity of the developer should be from 1.018 to 1.034. This method does not apply to nonaqueous solvent developer due to the
volatile nature of the product.
5.1.3 Black Lights— Black lights used for fluorescent penetrant inspection should be checked for black light output (with a
filter) for a minimum of 800 µW/cm at a distance of 381 mm (15 in.) from the lamp face. This measurement could be determined
by using a calibrated black light meter. The frequency of testing shall be at least once ever
...

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