ASTM F601-23

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.
SCOPE
1.1 This practice is intended as a standard 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Aug-2023
• 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

• Refers: ASTM E1417/E1417M-13 - Standard Practice for Liquid Penetrant Testing
• Effective Date: 01-Jun-2013
• Refers: ASTM E1417/E1417M-11 - Standard Practice for Liquid Penetrant Testing
• Effective Date: 15-Aug-2011
• Refers: ASTM E1417/E1417M-11e1 - Standard Practice for Liquid Penetrant Testing
• Effective Date: 15-Aug-2011

Overview

ASTM F601-23: Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants establishes guidelines for the nondestructive fluorescent penetrant inspection (FPI) of metallic surgical implants. Developed by ASTM Committee F04, this standard outlines a process to detect surface flaws in metallic implants, ensuring high reliability and patient safety in the medical device industry. By providing a standardized approach, ASTM F601-23 supports manufacturers, suppliers, and independent labs in identifying surface discontinuities such as cracks, porosity, and welding imperfections, all critical in maintaining the integrity of surgical implants.

Key Topics

• Scope and Purpose
  The standard defines best practices for performing and evaluating fluorescent penetrant inspections on metallic surgical implants. It also clarifies the responsibilities of users regarding safety, health, and regulatory compliance.

• Inspection Methodology

  • Outlines the required sensitivity level (minimum Level 3) and compatibility of penetrant products.
  • Details the steps for pre-cleaning, applying the penetrant, and developing indications.
  • Emphasizes adherence to verified practices, referencing ASTM E1417/E1417M and AMS 2644 for process control.

• Materials and Equipment Controls

  • Specifies regular testing and monitoring of penetrant water content and brightness according to ASTM D95 and E1135.
  • Addresses developer forms (dry, water-suspendable, nonaqueous) suitable for Type I, Method A penetrants.
  • Mandates daily and quarterly equipment checks, including UV-A radiometer assessments and ambient light monitoring to ensure reliability of fluorescent inspection.

• Evaluation and Acceptance Criteria

  • Acceptance or rejection parameters are agreed between purchaser and supplier.
  • Allows for indication verification by mutual agreement, ensuring flexibility for specific contract requirements.

• Personnel Qualification

  • Calls for examination personnel to be qualified via recognized standards such as ASNT SNT-TC-1A, CP-189, NAS-410, or ISO 9712, and certified by the employer or a certifying agency.

Applications

• Medical Device Manufacturing
  Fluorescent penetrant inspection per ASTM F601-23 is a critical quality assurance tool for manufacturers of metallic surgical implants, such as orthopedic devices, spinal implants, and cardiovascular supports.

• Supplier and Third-Party Testing
  This standard serves as a baseline reference for suppliers and independent laboratories performing final inspections or contract testing of metallic medical devices.

• Regulatory Compliance
  Adherence to ASTM F601-23 demonstrates due diligence in risk management and product safety, meeting both national and international regulatory requirements for medical devices.

• Continuous Quality Improvement
  The practice aids in early detection of manufacturing defects, reduces recall risk, and supports long-term device reliability in clinical use.

Related Standards

For comprehensive and consistent inspection methodologies, ASTM F601-23 references and complements several other standards:

• ASTM E165/E165M: Practice for Liquid Penetrant Testing for General Industry
• ASTM E1135: Test Method for Comparing the Brightness of Fluorescent Penetrants
• ASTM E1417/E1417M: Practice for Liquid Penetrant Testing
• ASTM D95: Test Method for Water in Petroleum Products and Bituminous Materials by Distillation
• SAE AMS 2644: Inspection Material, Penetrant
• ASNT SNT-TC-1A, CP-189: Qualification and Certification of Nondestructive Testing Personnel
• ISO 9712: Non-destructive Testing - Qualification and Certification of NDT Personnel
• NAS-410: Certification and Qualification of Nondestructive Test Personnel

Implementation of ASTM F601-23 ensures standardized, high-sensitivity detection of surface flaws in metallic surgical implants, helping organizations maintain compliance and uphold the highest quality standards in medical device manufacturing.

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F601 − 23
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
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* 4.2 The penetrant system used shall be Type I, Method A,
minimum of Level 3 sensitivity, in accordance with Practice
1.1 This practice is intended as a standard for fluorescent
E1417/E1417M.
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 in accordance with Practice E1417/E1417M.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
5. Preparation for Testing
priate safety, health, and environmental practices and deter-
5.1 Pre- and post-cleaning requirements are to be agreed
mine the applicability of regulatory limitations prior to use.
upon between the purchaser and supplier.
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
5.2 If sand/grit blasting is used for pre-cleaning, care shall
ization established in the Decision on Principles for the
be taken to ensure that defects are not masked or peened over.
Development of International Standards, Guides and Recom-
6. Penetrant Method Materials and Equipment Controls
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
6.1 The penetrant method materials deteriorate in usefulness
through contamination and age. System performance and
2. Referenced Documents
process control checks shall be performed in accordance with
2.1 ASTM Standards:
Practice E1417/E1417M.
E1417/E1417M Practice for Liquid Penetrant Testing
7. Evaluation
3. Significance and Use
7.1 The product acceptance and rejection criteria shall be as
3.1 This practice is intended to confirm the method of agreed upon between the purchaser and supplier.
obtaining and evaluating the fluorescent penetrant indications
7.2 Indication verification per Practice E1417/E1417M is
on metallic surgical implants.
permitted. If the purchaser has unique requirements, these shall
take precedence.
4. Fluorescent Penetrant Method
4.1 Perform fluorescent penetrant inspection of metallic 8. Personnel Certification
surgical implants in accordance with Practice E1417/E1417M.
8.1 If specified in the contractual agreement, personnel
performing examination to this practice shall be qualified in
This practice is under the jurisdiction of ASTM Committee F04 on Medical and accordance with a nationally or internationally recognized
Surgical Materials and Devices and is the direct responsibility of Subcommittee
nondestructive testing (NDT) personnel qualification practice
F04.12 on Metallurgical Materials.
or standard and certified by the employer or certifying agency,
Current edition approved Sept. 1, 2023. Published September 2023. Originally
as applicable.
approved in 1978. Last previous edition approved in 2018 as F601 – 18. DOI:
10.1520/F0601-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 9. Keywords
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
9.1 fluorescent; penetrant inspection; testing methods; sur-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. gical implants
*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 − 23
APPENDIX
(Nonmandatory Information)
X1. RATIONALE
X1.1 A method of nondestructive inspection, known as discontinuities that normally would not be visible by unaided
fluorescent penetrant inspection, is employed as a quality visual inspection.
control tool for surgical devices. This
...

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 − 18 F601 − 23
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
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 guidestandard 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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
D95 Test Method for Water in Petroleum Products and Bituminous Materials by Distillation
E165/E165M Practice for Liquid Penetrant Testing for General Industry
E1135 Test Method for Comparing the Brightness of Fluorescent Penetrants
E1417/E1417M Practice for Liquid Penetrant Testing
2.2 ASNT Documents:
Recommended Practice No. SNT-TC-1A
CP-189 Standard for Qualification and Certification of Nondestructive Testing Personnel
2.3 SAE Standard:
AMS 2644 Inspection Material, Penetrant
2.4 ISO Document:
ISO 9712 Non-destructive Testing – Qualification and Certification of NDT Personnel
2.5 NAS Document:
NAS-410 Certification and Qualification of Nondestructive Test Personnel
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.
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 April 1, 2018Sept. 1, 2023. Published May 2018September 2023. Originally approved in 1978. Last previous edition approved in 20132018 as
F601 – 13.F601 – 18. DOI: 10.1520/F0601-18.10.1520/F0601-23.
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.
*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 − 23
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/E165ME1417/
E1417M, Method A.
4.2 The penetrant system used shall conform to a minimum of Sensitivity Level 3, be Type I, Method A, minimum of Level 3
sensitivity, in accordance with thePractice E1417/E1417Mlatest revision of AMS 2644.
4.3 All penetrant materials shall be compatible with each other, and approved other in accordance with AMS-2644.Practice
E1417/E1417M.
5. Preparation for Testing
5.1 Pre- and post-cleaning requirements are to be agreed upon between the purchaser and supplier.
5.2 If sand/grit blasting is used for pre-cleaning, take care care shall be taken to ensure that defects are not masked or peened over.
6. Penetrant Method Materials Control and Equipment Controls
6.1 The penetrant method materials deteriorate in usefulness through contamination and age. The following controls shall be used
to evaluate the materials’System performance and process control checks shall be performed in accordance with Practice
E1417/E1417Musefulness unless the supplier’s requirements are more stringent:.
6.1.1 Penetrants:
6.1.1.1 Water Content of Non-Water-Based Water-Washable Penetrants—Water content of non-water-based Method A penetrants
shall be checked monthly in accordance with Test Method D95. 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 Penetrant Brightness—Brightness tests of in-use fluorescent penetrants shall be conducted quarterly. Tests shall be in
accordance with Test Method E1135 with a representative sample of the unused penetrant serving as the reference. Brightness
values less than 90 % of the unused penetrant brightness are unsatisfactory and the in-use penetrants shall be discarded or otherwise
corrected, as appropriate.
6.1.2 Developer:
6.1.2.1 The following forms of developers are allowed for use with Type 1 Method A penetrants:
Form A: Dry developers.
Form C: Water suspendable developers.
Form D: Nonaqueous developers for Type 1 penetrants.
6.1.2.2 The parameters for controlling the application and required tests frequencies of developers are located in Practice
E1417/E1417M and Practice E1417/E1417M, Table 1.
6.1.3 Black Lights—Portable, hand-held, permanently mounted or fixed black lights used to inspect parts shall be checked for
intensity daily or prior to use, and after bulb replacement, using a calibrated UV-A radiometer. The minimum acceptable intensity
2 2
is 1000 μW/cm (10 W/m ) at 15 in. (38.1 cm) from the front of the filter to the face of the sensor. Black lights shall be checked
weekly for cleanliness and integrity and shall be cleaned, repaired, or replaced as appropriate.
6.1.4 Ambient Light Intensity—Ambient visible light background shall not exceed 2 fc (21.5 lx) at the examination surface and
shall be checked using a calibrated light meter quarterly or when any changes or construction, or both, are made in the inspection
area.
F601 − 23
6.1.5 Penetrant System Performance—The penetrant system’s overall performance shall be checked daily as specified in Practice
E1417/E1417M, paragraph 7.8.3.
6.1.6 Additional Required Tests—The following tests shall be performed in accordance with Practice E1417/E1417M:
...