ASTM F601-13

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

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.
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: 30-Nov-2013
• 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 F601-03(2008) - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• Effective Date: 01-Dec-2013
• Referred By: ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2013
• Referred By: ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
• Effective Date: 01-Dec-2013
• Referred By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Dec-2013
• Referred By: ASTM F3160-21 - Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
• Effective Date: 01-Dec-2013
• 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-2013
• Referred By: ASTM F1108-21 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
• Effective Date: 01-Dec-2013
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Dec-2013
• Referred By: ASTM F961-20 - Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
• Effective Date: 01-Dec-2013
• Referred By: ASTM F621-12(2021)e1 - Standard Specification for Stainless Steel Forgings for Surgical Implants
• Effective Date: 01-Dec-2013
• Referred By: ASTM F1801-20 - Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
• Effective Date: 01-Dec-2013
• Referred By: ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
• Effective Date: 01-Dec-2013
• Referred By: ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
• Effective Date: 01-Dec-2013
• Referred By: ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• Effective Date: 01-Dec-2013
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 01-Dec-2013

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 − 13
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
1
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. Preparation for Testing
2
2.1 ASTM Standards:
5.1 Pre- and post-cleaning requirements are to be agreed
D95 Test Method for Water in Petroleum Products and
upon between the purchaser and supplier.
Bituminous Materials by Distillation
E165 Practice for Liquid Penetrant Examination for General
6. Penetrant Method Materials Control
Industry
6.1 Thepenetrantmethodmaterialsdeteriorateinusefulness
E1135 Test Method for Comparing the Brightness of Fluo-
throughcontaminationandage.Thefollowingcontrolsshallbe
rescent Penetrants
used to evaluate the materials’usefulness unless the supplier’s
E1417 Practice for Liquid Penetrant Testing
requirements are more stringent:
3
2.2 ASNT Recommended Practice:
6.1.1 Penetrants:
Recommended Practice No. SNT-TC-1A
6.1.1.1 Water Content of Non-Water-Based Water-Washable
4
2.3 SAE Standard:
Penetrants—Water content of non-water-based MethodApen-
AMS 2644 Inspection Material, Penetrant
etrants shall be checked monthly in accordance with Test
Method D95. If the water content of the in-use penetrant
3. Significance and Use
exceeds 5 %, the penetrant shall either be discarded or
3.1 This practice is intended to confirm the method of
sufficientunusedpenetrantaddedtoreducethewatercontentto
obtaining and evaluating the fluorescent penetrant indications
below 5 %.
on metallic surgical implants.
6.1.1.2 Penetrant Brightness—Brightness tests of in-use
fluorescent penetrants shall be conducted quarterly. Tests shall
3.2 The product acceptance and rejection criteria will be as
beinaccordancewithTestMethodE1135witharepresentative
agreed upon between the purchaser and the supplier.
sample of the unused penetrant serving as the reference.
Brightness values less than 90 % of the unused penetrant
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
brightness are unsatisfactory and the in-use penetrants shall be
Surgical Materials and Devices and is the direct responsibility of Subcommittee
discarded or otherwise corrected, as appropriate.
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2013. Published January 2014. Originally 6.1.2 Developer:
approved in 1978. Last previous edition approved in 2008 as F601 – 03 (2008).
6.1.2.1 The following forms of developers are allowed for
DOI: 10.1520/F0601-13.
use with Type 1 Method A penetrants:
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Form A: Dry developers.
Standards volume information, refer to the standard’s Document Summary page on Form C: Water suspendable developers.
the ASTM website. Form D: Nonaqueous developers for Type 1 penetrants.
3
AvailablefromAmericanSocietyforNondestructiveTesting(ASNT),P.O.Box
6.1.2.2 The parameters for controlling the application and
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org.
4
required tests frequencies of developers are located in Practice
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
Dr., Warrendale, PA 15096-0001, http://www.sae.org. E1417 and Practice E1417, Table 1.
*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

---------------------- Page: 1 ----------------------
F601 − 13
6.1.3 Black Lights—Portable, hand-held, permanently 6.1.6.1 Wash water temperature and temperature check at
mounted or fixed black lights used to inspect parts shall be the start of every working shift, and
checked for intensity daily or prior to use, and
...

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 − 03 (Reapproved 2008) F601 − 13
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
1
Implants
This standard is issued under the fixed designation F601; 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 (´) 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
2.1 ASTM Standards:
D95 Test Method for Water in Petroleum Products and Bituminous Materials by Distillation
E165 Practice for Liquid Penetrant Examination for General Industry
E433E1135 Reference Photographs for Liquid Penetrant InspectionTest Method for Comparing the Brightness of Fluorescent
Penetrants
E1417 Practice for Liquid Penetrant Testing
3
2.2 ASNT Recommended Practice:
Recommended Practice No. SNT-TC-1A
4
2.3 SAE Standard:
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 E165, Method A.
4.2 The penetrant system used shall conform to a minimum of Sensitivity Level 3, in accordance with the latest revision of AMS
2644.
4.3 All penetrant materials shall be compatible with each other.
5. Preparation for Testing
5.1 Pre- and post-cleaning requirements are to be agreed upon between the purchaser and supplier.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
Current edition approved Feb. 1, 2008Dec. 1, 2013. Published May 2008January 2014. Originally approved in 1978. Last previous edition approved in 20032008 as
F601 – 03.F601 – 03 (2008). DOI: 10.1520/F0601-03R08.10.1520/F0601-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 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.
4
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
1

---------------------- Page: 1 ----------------------
F601 − 13
6. Penetrant Method Materials Control
6.1 The penetrant method materials deteriorate in usefulness through contamination and age. The following controls shouldshall
be used to evaluate the materials’materials’ usefulness unless the supplier’ssupplier’s requirements are more stringent:
6.1.1 Penetrants:
6.1.1.1 Water Content—Content of Non-Water-Based Water-Washable Penetrants—Where there is a possibility of water
contamination to penetrant materials, the water content should be determined by Water content of non-water-based Method A
penetrants shall be checked monthly in accordance with Test Method D95. The water content shall not exceed 10 %. The frequency
of testing shall be at least once every 30 days for open containers.If the water content of the in-use penetrant exceeds 5 %, the
penetrant shall either be discarded or sufficient unused penetrant added to reduce the water content to below 5 %.
6.1.1.2 FluorescentPenetrant Brightness—Fluorescent brightness should be determined at least once every 30 days or before
use byBrightness tests of in-use fluorescent penetrants shall be conducted quarterly. Tests shall be in accordance with Test Method
E1135 comparison of samples of the
...