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ASTM F601-18

(Practice)

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

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, 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
Historical
Publication Date
31-Mar-2018
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
Current Stage
Ref Project

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ASTM F601-18 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
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REDLINE ASTM F601-18 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsREDLINE ASTM F601-18 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
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REDLINE ASTM F601-18 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 18
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.
5
1. Scope* 2.4 ISO Document:
ISO 9712 Non-destructive Testing – Qualification and Cer-
1.1 This practice is intended as a guide for fluorescent
tification of NDT Personnel
penetrant inspection of metallic surgical implants.
6
2.5 NAS Document:
1.2 This standard does not purport to address all of the
NAS-410 Certification and Qualification of Nondestructive
safety concerns, if any, associated with its use. It is the
Test Personnel
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3. Significance and Use
mine the applicability of regulatory limitations prior to use.
3.1 This practice is intended to confirm the method of
1.3 This international standard was developed in accor-
obtaining and evaluating the fluorescent penetrant indications
dance with internationally recognized principles on standard-
on metallic surgical implants.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 3.2 The product acceptance and rejection criteria will be as
mendations issued by the World Trade Organization Technical agreed upon between the purchaser and the supplier.
Barriers to Trade (TBT) Committee.
4. Fluorescent Penetrant Method
2. Referenced Documents
4.1 Perform fluorescent penetrant inspection of metallic
2
2.1 ASTM Standards:
surgical implants in accordance with Practice E165/E165M,
D95 Test Method for Water in Petroleum Products and
Method A.
Bituminous Materials by Distillation
4.2 The penetrant system used shall conform to a minimum
E165/E165M Practice for Liquid Penetrant Examination for
of Sensitivity Level 3, in accordance with the latest revision of
General Industry
AMS 2644.
E1135 Test Method for Comparing the Brightness of Fluo-
4.3 All penetrant materials shall be compatible with each
rescent Penetrants
other, and approved in accordance with AMS-2644.
E1417/E1417M Practice for Liquid Penetrant Testing
3
2.2 ASNT Documents:
5. Preparation for Testing
Recommended Practice No. SNT-TC-1A
CP-189 Standard for Qualification and Certification of Non-
5.1 Pre- and post-cleaning requirements are to be agreed
destructive Testing Personnel upon between the purchaser and supplier.
4
2.3 SAE Standard:
5.2 If sand/grit blasting is used for pre-cleaning, take care to
AMS 2644 Inspection Material, Penetrant
ensure that defects are not masked or peened over.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and 6. Penetrant Method Materials Control
Surgical Materials and Devices and is the direct responsibility of Subcommittee
6.1 The penetrant method materials deteriorate in usefulness
F04.12 on Metallurgical Materials.
Current edition approved April 1, 2018. Published May 2018. Originally through contamination and age. The following controls shall be
approved in 1978. Last previous edition approved in 2013 as F601 – 13. DOI:
used to evaluate the materials’ usefulness unless the supplier’s
10.1520/F0601-18.
requirements are more stringent:
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
5
the ASTM website. Available from International Organization for Standardization (ISO), ISO
3
Available from American Society for Nondestructive Testing (ASNT), P.O. Box Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org. Geneva, Switzerland, http://www.iso.org.
4 6
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Available from Aerospace Industries Association (AIA/NAS), 1000 Wilson
Dr., Warrendale, PA 15096-0001, http://www.sae.org. Boulevard, Suite 1700, Arlington, VA 22209-3928.
*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 − 18
6.1.1 Penetrants: 6.1.4 Ambient Light Intensity—Ambient visible light back-
ground shall not exceed 2 fc (21.5 lx) at the examination
6.1.1.1 Water Content of Non-Water-Based Water-Washable
surface and shall be checked using a calibrated li
...

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 − 13 F601 − 18
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 safety, health, and healthenvironmental 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
2.1 ASTM Standards:
D95 Test Method for Water in Petroleum Products and Bituminous Materials by Distillation
E165E165/E165M Practice for Liquid Penetrant Examination for General Industry
E1135 Test Method for Comparing the Brightness of Fluorescent Penetrants
E1417E1417/E1417M Practice for Liquid Penetrant Testing
3
2.2 ASNT Recommended Practice:Documents:
Recommended Practice No. SNT-TC-1A
CP-189 Standard for Qualification and Certification of Nondestructive Testing Personnel
4
2.3 SAE Standard:
AMS 2644 Inspection Material, Penetrant
5
2.4 ISO Document:
ISO 9712 Non-destructive Testing – Qualification and Certification of NDT Personnel
6
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.
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 E165E165/E165M,
Method A.
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 Dec. 1, 2013April 1, 2018. Published January 2014May 2018. Originally approved in 1978. Last previous edition approved in 20082013 as
F601 – 03 (2008).F601 – 13. DOI: 10.1520/F0601-13.10.1520/F0601-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. 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.
5
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
6
Available from Aerospace Industries Association (AIA/NAS), 1000 Wilson Boulevard, Suite 1700, Arlington, VA 22209-3928.
*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 − 18
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.other, and approved in accordance with AMS-2644.
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 to ensure that defects are not masked or peened over.
6. Penetrant Method Materials Control
6.1 The penetrant method materials deteriorate in usefulness through contamination and
...

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SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

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