ASTM F3160-21
(Guide)Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
SIGNIFICANCE AND USE
5.1 The metallurgical properties of materials used to manufacture absorbable metallic implants can influence biological reactions and mechanical interaction with soft and hard tissue in the body. This standard guide describes a suggested material characterization scheme for absorbable metallic materials to ensure reproducibility of properties prior to their manufacture into medical implants.
SCOPE
1.1 This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of absorbable metallic materials intended for medical implant applications. This guide is primarily intended for absorbable metallic materials that undergo further processing into a fabricated final device. Therefore, this standard does not require assessments that are more appropriately conducted on the final device, such as biological evaluation. However, a few relevant standards for finished implant devices are included for information purposes.
1.2 The purpose of this guide is to identify appropriate test methods and relevant medical product standards that can be used to develop future standards for new or modified absorbable metallic materials.
1.3 This guide is not intended to cover other major classes of absorbable materials such as polymers, ceramics, composites, and tissue-engineered materials.
1.4 This standard guide is focused on the chemical, physical, microstructural, and mechanical properties plus inspection guidelines for metallic materials that are used for medical implants designed to be absorbed in the body over a period of time. This guide focuses on material characterizations and does not address device specific mechanical testing that may be necessary to determine safety and functionality of the implant.
1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.
1.6 Since surface modifications of medical implants are generally applied in the latter stages of manufacturing, this standard guide does not cover the characterization of either absorbable or non-absorbable surface coatings that are metallic in origin such as oxides or from the addition of other materials such as ceramics or polymers. However, this standard does apply to absorbable metallic materials, regardless of the presence or absence of a coating.
1.7 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.
1.8 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
Relations
Buy Standard
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: F3160 − 21
Standard Guide for
Metallurgical Characterization of Absorbable Metallic
1
Materials for Medical Implants
This standard is issued under the fixed designation F3160; 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* in origin such as oxides or from the addition of other materials
such as ceramics or polymers. However, this standard does
1.1 This guidance document provides metallurgical charac-
apply to absorbable metallic materials, regardless of the
terization information that may be beneficial in the evaluation
presence or absence of a coating.
of absorbable metallic materials intended for medical implant
1.7 This standard does not purport to address all of the
applications. This guide is primarily intended for absorbable
safety concerns, if any, associated with its use. It is the
metallic materials that undergo further processing into a
responsibility of the user of this standard to establish appro-
fabricated final device. Therefore, this standard does not
priate safety, health, and environmental practices and deter-
require assessments that are more appropriately conducted on
mine the applicability of regulatory limitations prior to use.
the final device, such as biological evaluation. However, a few
1.8 This international standard was developed in accor-
relevant standards for finished implant devices are included for
dance with internationally recognized principles on standard-
information purposes.
ization established in the Decision on Principles for the
1.2 The purpose of this guide is to identify appropriate test
Development of International Standards, Guides and Recom-
methods and relevant medical product standards that can be
mendations issued by the World Trade Organization Technical
used to develop future standards for new or modified absorb-
Barriers to Trade (TBT) Committee.
able metallic materials.
1.3 This guide is not intended to cover other major classes
2. Referenced Documents
of absorbable materials such as polymers, ceramics,
2
2.1 ASTM Standards:
composites, and tissue-engineered materials.
A262 Practices for Detecting Susceptibility to Intergranular
1.4 This standard guide is focused on the chemical,
Attack in Austenitic Stainless Steels
physical, microstructural, and mechanical properties plus in-
A342/A342M Test Methods for Permeability of Weakly
spection guidelines for metallic materials that are used for
Magnetic Materials
medical implants designed to be absorbed in the body over a
A480/A480M Specification for General Requirements for
period of time. This guide focuses on material characteriza-
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
tions and does not address device specific mechanical testing
Sheet, and Strip
that may be necessary to determine safety and functionality of
A484/A484M Specification for General Requirements for
the implant.
Stainless Steel Bars, Billets, and Forgings
A555/A555M Specification for General Requirements for
1.5 Compliance with materials specifications developed in
Stainless Steel Wire and Wire Rods
accordance with this standard may not necessarily result in a
A751 Test Methods and Practices for Chemical Analysis of
material suitable for its intended purpose. Additional testing
Steel Products
specific to the intended use may be required.
A938 Test Method for Torsion Testing of Wire
1.6 Since surface modifications of medical implants are
A957 SpecificationforInvestmentCastings,SteelandAlloy,
generally applied in the latter stages of manufacturing, this
Common Requirements, for General Industrial Use
standard guide does not cover the characterization of either
B69 Specification for Rolled Zinc
absorbable or non-absorbable surface coatings that are metallic
B80 Specification for Magnesium-Alloy Sand Castings
B86 Specification for Zinc and Zinc-Aluminum (ZA) Alloy
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.12 on Metallurgical Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Feb. 1, 2021. Published March 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2016. Last previous edition approved in 2016 as F3160 – 16. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F3160-21. the ASTM website.
*A Summ
...
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: F3160 − 16 F3160 − 21
Standard Guide for
Metallurgical Characterization of Absorbable Metallic
1
Materials for Medical Implants
This standard is issued under the fixed designation F3160; 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 Scope*
1.1 This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of
absorbable metallic materials intended for medical implant applications. This guide is primarily intended for absorbable metallic
materials that undergo further processing into a fabricated final device. Therefore, this standard does not require assessments that
are more appropriately conducted on the final device, such as biological evaluation. However, a few relevant standards for finished
implant devices are included for information purposes.
1.2 The purpose of this guide is to identify appropriate test methods and relevant medical product standards that can be used to
develop future standards for new or modified absorbable metallic materials.
1.3 This guide is not intended to cover other major classes of absorbable materials such as polymers, ceramics, composites, and
tissue-engineered materials.
1.4 This standard guide is focused on the chemical, physical, microstructural, and mechanical properties plus inspection guidelines
for metallic materials that are used for medical implants designed to be absorbed in the body over a period of time. This guide
focuses on material characterizations and does not address device specific mechanical testing that may be necessary to determine
safety and functionality of the implant.
1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material
suitable for its intended purpose. Additional testing specific to the intended use may be required.
1.6 Since surface modifications of medical implants are generally applied in the latter stages of manufacturing, this standard guide
does not cover the characterization of either absorbable or non-absorbable surface coatings that are metallic in origin such as oxides
or from the addition of other materials such as ceramics or polymers. However, this standard does apply to absorbable metallic
materials, regardless of the presence or absence of a coating.
1.7 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.
1.8 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.
1
This guide 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, 2016Feb. 1, 2021. Published May 2016March 2021. Originally approved in 2016. Last previous edition approved in 2016 as F3160 – 16.
DOI: 10.1520/F3160–16.10.1520/F3160-21.
*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 ----------------------
F3160 − 21
2. Referenced Documents
2
2.1 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A342/A342M Test Methods for Permeability of Weakly Magnetic Materials
A480/A480M Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
A751 Test Methods and Practices for Chemical Analysis of Steel Products
A938 Test Method for Torsion Testing of Wire
A957 Specification for Investment Castings, Steel and Alloy, Common Re
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.