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
- Status
- Published
- Publication Date
- 31-Jan-2021
- Technical Committee
- F04 - Medical and Surgical Materials and Devices
- Drafting Committee
- F04.12 - Metallurgical Materials
Relations
- Effective Date
- 01-Jan-2024
- Effective Date
- 01-Jan-2024
- Effective Date
- 15-Nov-2023
- Effective Date
- 01-Nov-2023
- Effective Date
- 01-Nov-2023
- Effective Date
- 01-Nov-2023
- Refers
ASTM B86-23 - Standard Specification for Zinc and Zinc-Aluminum (ZA) Alloy Foundry and Die Castings - Effective Date
- 01-Nov-2023
- Effective Date
- 01-Sep-2023
- Effective Date
- 01-Mar-2023
- Effective Date
- 01-Aug-2020
- Effective Date
- 05-May-2020
- Effective Date
- 01-Feb-2020
- Effective Date
- 01-Feb-2020
- Effective Date
- 01-Nov-2019
- Effective Date
- 15-Sep-2019
Overview
ASTM F3160-21: Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants is an international standard developed by ASTM International. This guide provides a comprehensive framework for the evaluation and characterization of absorbable metallic materials used in medical implants. It is intended to ensure the reproducibility and reliability of material properties before these materials undergo further processing and fabrication into final implantable devices.
Absorbable metallic materials are increasingly used in various medical applications where temporary support is needed, followed by safe degradation and absorption within the body. The metallurgical properties of these materials can significantly influence both mechanical performance and biological interactions, making robust characterization essential for product development and patient safety.
Key Topics
Material Characterization Scheme
- Focus on chemical, physical, microstructural, and mechanical properties of absorbable metals
- Inspection guidelines for material quality and uniformity prior to device fabrication
Applicable Material Classes
- Magnesium-based (Mg), iron-based (Fe), and zinc-based (Zn) alloys widely documented for absorbable medical implant applications
Testing and Inspection Methods
- Guidelines for chemical analysis, microstructure assessment, mechanical properties, and degradation testing
- Recommendations for non-destructive inspection methods, such as visual examination, radiography, and ultrasonic testing
Limitations
- Excludes characterization of absorbable or non-absorbable surface coatings and final device-specific testing such as biological evaluation
- Additional application-specific testing may be required for particular implant designs
- Does not address major classes of absorbable materials other than metals (e.g. polymers, ceramics, composites)
Quality and Compliance
- Encourages adherence to internationally recognized quality management systems such as ISO 9001 and ISO 13485
Applications
ASTM F3160-21 provides practical value for stakeholders involved in the development and manufacturing of medical devices utilizing absorbable metals. Major applications include:
Implant Device Development
- Establishes a baseline for selecting and qualifying novel absorbable metallic materials for cardiovascular, orthopedic, surgical, and diagnostic implants
Material Supplier Certification
- Provides requirements for suppliers to certify that materials meet defined metallurgical standards before further processing
Regulatory Assessment and Product Approval
- Supports compliance with international regulatory requirements for medical implant materials through reference to established test methods and standards
Research and Innovation
- Serves as a guideline for the development of new alloy compositions and novel processing methods in the field of absorbable metals for medical implants
Related Standards
A wide range of referenced standards complement ASTM F3160-21 for comprehensive material characterization:
ASTM Standards
- ASTM E8/E8M: Tension Testing of Metallic Materials
- ASTM E18: Hardness Testing
- ASTM F601, F629: Non-destructive testing of metallic implants
- ASTM F3268: In vitro degradation testing of absorbable metals
ISO Standards
- ISO 10993-15, 17, 18: Biological evaluation, chemical characterization, and quantification of degradation products for medical devices
- ISO 13485: Quality management for medical devices
- ISO/TS 20721: General guidelines for absorbable metallic implant assessment
AMS Standards
- AMS 2248: Chemical check analysis limits
- AMS 2630/2632: Ultrasonic inspection methods
Key terminology relevant to this standard includes absorbable, bioabsorbable, degradable, resorbable, and biodegradable metals for surgical implants. For effective searches and implementation, consider all variant terms used in the literature and regulatory guidance.
For additional details on referenced standards, consult the ASTM and ISO websites to ensure up-to-date compliance and integration in quality systems.
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Frequently Asked Questions
ASTM F3160-21 is a guide published by ASTM International. Its full title is "Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants". This standard covers: 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.
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.
ASTM F3160-21 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F3160-21 has the following relationships with other standards: It is inter standard links to ASTM E8/E8M-24, ASTM A484/A484M-24, ASTM E340-23, ASTM E45-18a(2023), ASTM A480/A480M-23b, ASTM E407-23, ASTM B86-23, ASTM A484/A484M-23a, ASTM A484/A484M-23, ASTM F2393-12(2020), ASTM A484/A484M-20a, ASTM F629-20, ASTM F2895-20, ASTM E2627-13(2019), ASTM F2182-19. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F3160-21 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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,
2.1 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
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. 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 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
F3160 − 21
Foundry and Die Castings F2182 Test Method for Measurement of Radio Frequency
B90/B90M Specification for Magnesium-Alloy Sheet and Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging
Plate
F2213 Test Method for Measurement of Magnetically In-
B107/B107M Specification for Magnesium-Alloy Extruded
duced Torque on Medical Devices in the Magnetic Reso-
Bars, Rods, Profiles, Tubes, and Wire
nance Environment
B199 Specification for Magnesium-Alloy Permanent Mold
F2229 Specification for Wrought, Nitrogen Strengthened
Castings
23Manganese-21Chromium-1Molybdenum Low-Nickel
B403 Specification for Magnesium-Alloy Investment Cast-
Stainless Steel Alloy Bar and Wire for Surgical Implants
ings
(UNS S29108)
B557M Test Methods for Tension Testing Wrought and Cast
F2393 Specification for High-Purity Dense Magnesia Par-
Aluminum- and Magnesium-Alloy Products (Metric)
tially Stabilized Zirconia (Mg-PSZ) for Surgical Implant
B661 Practice for Heat Treatment of Magnesium Alloys
Applications
B949 Specification for General Requirements for Zinc and
F2581 Specification for Wrought Nitrogen Strengthened
Zinc Alloy Products
11Manganese-17Chromium-3Molybdenum Low-Nickel
B953 Practice for Sampling Magnesium and Magnesium
Stainless Steel Alloy Bar and Wire for Surgical Implants
Alloys for Spectrochemical Analysis
(UNS S29225)
B954 Test Method for Analysis of Magnesium and Magne-
F2895 Practice for Digital Radiography of Cast Metallic
sium Alloys by Atomic Emission Spectrometry
Implants
D3648 Practices for the Measurement of Radioactivity
F2902 Guide for Assessment of Absorbable Polymeric Im-
E8/E8M Test Methods for Tension Testing of Metallic Ma-
plants
terials
F3268 Guide for in vitro Degradation Testing ofAbsorbable
E18 Test Methods for Rockwell Hardness of Metallic Ma-
Metals
terials
IEEE/ASTM SI 10 American National Standard for Metric
E29 Practice for Using Significant Digits in Test Data to
Practice
Determine Conformance with Specifications
2.2 Aerospace Material Standards (AMS):
E45 Test Methods for Determining the Inclusion Content of
AMS 2248 Chemical Check Analysis Limits Corrosion and
Steel
Heat Resistant Steels and Alloys, Maraging and Other
E112 Test Methods for Determining Average Grain Size
Highly-Alloyed Steels, and Iron Alloys
E290 Test Methods for Bend Testing of Material for Ductil-
AMS 2630 Inspection, Ultrasonic Product Over 0.5 inch
ity
(12.7 mm) Thick
E340 Practice for Macroetching Metals and Alloys
AMS 2632 Ultrasonic Inspection of Thin Materials
E354 Test Methods for Chemical Analysis of High- 4
2.3 ISO Standards:
Temperature,Electrical,Magnetic,andOtherSimilarIron,
ISO 404 Steel and Steel Products—General Technical De-
Nickel, and Cobalt Alloys
livery Requirements
E384 Test Method for Microindentation Hardness of Mate-
ISO 643 Steels—Micrographic Determination of theAppar-
rials
ent Grain Size
E407 Practice for Microetching Metals and Alloys
ISO 3116 Magnesium and Magnesium Alloys—Wrought
E536 Test Methods for ChemicalAnalysis of Zinc and Zinc
Magnesium Alloys—Fourth edition
Alloys
ISO 3815-1 Zinc and ZincAlloys—Part 1:Analysis of Solid
E1245 Practice for Determining the Inclusion or Second-
Samples by Optical Emission Spectrometry
Phase Constituent Content of Metals byAutomatic Image
ISO 3815-2 Zinc and Zinc Alloys—Part 2: Analysis by
Analysis Inductively Coupled Optical Emission Spectrometry
E1382 Test Methods for Determining Average Grain Size ISO 4967 Steel—Determination of Content of Nonmetallic
Inclusions—Micrographic Method Using Standard Dia-
Using Semiautomatic and Automatic Image Analysis
grams
E1441 Guide for Computed Tomography (CT)
ISO 6892-1 Metallic Materials—Tensile Testing—Part 1:
E2627 Practice for Determining Average Grain Size Using
Method of Test at Room Temperature
Electron Backscatter Diffraction (EBSD) in Fully Recrys-
ISO 7800 Metallic materials—Wire—Simple torsion test
tallized Polycrystalline Materials
ISO 10993-15 Biological Evaluation of Medical Devices—
F601 Practice for Fluorescent Penetrant Inspection of Me-
Part 15: Identification and Quantification of Degradation
tallic Surgical Implants
Products from Metals and Alloys
F629 Practice for Radiography of Cast Metallic Surgical
ISO 10993-17 Biological Evaluation of Medical Devices—
Implants
F2052 Test Method for Measurement of Magnetically In-
duced Displacement Force on Medical Devices in the
Available from SAE International (SAE), 400 Commonwealth Dr.,Warrendale,
Magnetic Resonance Environment
PA 15096, http://www.sae.org.
F2119 Test Method for Evaluation of MR Image Artifacts 4
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
from Passive Implants 4th Floor, New York, NY 10036, http://www.ansi.org.
F3160 − 21
Part 17: Establishment ofAllowable Limits for Leachable in the body.This standard guide describes a suggested material
Substances characterization scheme for absorbable metallic materials to
ISO 10993-18 Biological Evaluation of Medical Devices— ensure reproducibility of properties prior to their manufacture
Part 18: Chemical Characterization of Materials into medical implants.
ISO/TS 10993-19-Part 19 Physico-chemical, Morphological
6. Characterization
and Topographical Characterization of Materials
ISO 13067 Microbeam Analysis—Electron Backscatter
6.1 Overview:
Diffraction—Measurement of Average Grain Size 6.1.1 The metallurgical characterization of absorbable me-
ISO 13485 Medical Devices Quality Management
tallic materials includes the influence of chemical,
Systems—Requirements for Regulatory Purposes— microstructural, physical, mechanical, and degradation proper-
Second edition
ties in addition to material inspection methods that are utilized
ISO 16220 Magnesium and Magnesium Alloys— to document initial material quality and uniformity.
Magnesium Alloy Ingots and Castings
6.1.2 Thismetallurgicalcharacterizationguidewillfocuson
ISO/TS 17137 Cardiovascular Implants and Extracorporeal magnesium (Mg)-base, iron (Fe)-base, and zinc (Zn)-base
Systems—Cardiovascular Absorbable Implants alloyssincethesearethemainclassesofmetallicmaterialsthat
ISO/TS 20721:2020 Implants for surgery—General guide-
have been documented in the literature for potential absorbable
lines and requirements for assessment of absorbable metallic implant applications. This guide may be applicable to
metallic implants
other absorbable alloy systems.
ISO 24173 Microbeam Analysis—Guidelines for Orienta- 6.1.3 The below described evaluations are general in their
tion Measurement Using Electron Backscatter Diffraction
scope,withadditionalunlistedmaterialassessmentspotentially
ISO/TR 37137 Biological Evaluation of Medical Devices— needed to address the performance requirements of a specific
Guidance for Absorbable Implants
implant application.
ISO 9001 Quality Management Systems—Requirements
6.2 General:
6.2.1 General requirements are specified in Specifications
3. Terminology
B90/B90M and B107/B107M for wrought Mg-base product
3.1 Definitions:
forms; Specifications A480/A480M, A484/A484M, and A555/
3.1.1 absorbable, adj—in the body, an initially distinct
A555M for wrought Fe-base product forms; and Specification
foreign material or substance that either directly or through
B949 for Zn-base product forms.
intended degradation can pass through or be metabolized or
6.2.2 Requirements are specified in Specification B403 for
assimilated by cells and/or tissue. F2902
Mg-basecastings;SpecificationA957forFe-basecastings;and
Specification B86 for Zn-base castings.
4. Summary of Guide
6.3 Chemical:
4.1 Novel absorbable metallic implant materials that do not
6.3.1 Some examples of absorbable Mg compositions that
yet have industry standards are being developed for use in
have been investigated to date include pure Mg, conventional
applications such as cardiovascular, orthopedic, general
Mg alloys, and experimental Mg alloys containing combina-
surgical, and diagnostic. The lack of a standard guide for the
tions of aluminum (Al), calcium (Ca), lithium (Li), manganese
metallurgical characterization of these new materials may
(Mn), neodymium (Nd), rare earth (RE), silver (Ag), yttrium
contribute to material property non-uniformity which could
(Y), zinc (Zn), or zirconium (Zr).
create variation in the observed performance of the final
6.3.2 Some examples of absorbable Fe compositions that
product. It is the intent of this guide to provide material
have been investigated to date include pure Fe, a range of
propertyinformation,correspondingtestmethods,andrelevant
Fe-Mn alloys with and without silicon (Si) or palladium (Pd),
medical product standards to serve as a guide for the metal-
and novel binary Fe compositions containing either aluminum
lurgical characterization of new or modified materials. These
(Al), boron (B), carbon (C), cobalt (Co), sulfur (S), or tungsten
guidelines are tabulated to assist with the development of
(W).
specifications for new or modified absorbable metallic materi-
6.3.3 Some examples of absorbable Zn compositions that
als.
have been investigated to date include pure Zn, commercial Zn
4.2 This guide is focused on providing a characterization
alloys, and binary Zn-Mg combinations.
scheme for materials prior to their fabrication into a finished
6.3.4 Relevant technical information has been published
medical implant. The characterization and testing of absorb-
for the majority of the absorbable alloy compositions docu-
able metallic materials after they have been manufactured into
mented in 6.3.1 and 6.3.2.
finished and sterilized medical implants will depend on the
6.3.5 Elemental concentrations present at specified major,
design, mass, shape, anatomic location, and end-use applica-
minor, residual, or trace levels are defined in Test Method
tion.
A751 and ISO 3116. Within this context, a trace classification
doesnotincludeelementsthatareaspecifiedcomponentofthe
5. Significance and Use
alloy, regardless of concentration.
5.1 The metallurgical properties of materials used to manu-
facture absorbable metallic implants can influence biological
Hendra Hermawan, Biodegradable Metals from Concept to Applications,
reactions and mechanical interaction with soft and hard tissue Spinger, 2012, ISSN 2192-1091; ISSN 2192-1105 (electronic).
F3160 − 21
NOTE 1—For the materials covered by this standard, no biocompatibil-
tion of one of the electron backscatter diffraction (EBSD)
ity assessment is required since this standard focuses on characterization
methods that are described in Test Method E1382, Practice
of materials that are subject to further fabrication into a final device.
E2627,andISO13067,allofwhicharesuitedforbothcastand
However, since the overall composition of any absorbable implant can be
wrought alloys.
expected to have a significant impact on its biocompatibility, the entire
composition of materials covered by this standard (including the intended 6.5.3 Casting alloy is usually in the form of shot, bar, or
composition, metallic degradation species, and any residual or trace
ingots and may exhibit lamellar, dendritic, and/or equiaxed
metallic or nonmetallic impurities) should be preliminarily assessed for
microstructural characteristics after melting into castings fol-
their potential impact on any later ISO 10993 risk assessment of the final
lowed by heat treating.
device. In addition to the ISO 10993 series, additional supplemental
6.5.4 Metastable martensitic phase transformations such as
guidance specific for the biological evaluation of absorbable implants can
be found in ISO TR37137. (γFe,γMn→α') may occur in specific Fe-Mn compositions
during cold working and magnetic permeability measurements
6.3.6 Chemical analysis may be performed according to
may be used to verify nonmagnetic stability.
TestMethodE354forFe-basematerials,TestMethodB954for
6.5.5 A magnetic surface layer may be formed on high
Mg-base materials, and Test Method E536 for Zn-base mate-
manganese (Mn) containing alloys as a result of thermal
rials.
oxidation of Mn during hot working or annealing operations
6.3.7 Chemical check analysis tolerance limits specified in
and may increase the magnetic permeability. The magnetic
AMS 2248 may be used to verify heat analysis of Fe-base
surface layer shall be removed from the finished product prior
materials.
to its use as a medical device (see material standards Specifi-
6.3.8 Rare earth (RE) elements include the fifteen lan-
cation F2229Appendix X1.7, and Specification F2581Appen-
thanide elements (atomic number 57 to 71) plus the transition
dix X1.6).
metals scandium (Sc) and yttrium (Y).
6.5.6 The presence of nonmetallic inclusion types such as
6.3.9 Processing aids and binders that may be used with
sulfide, alumina, silicate, and globular oxides in the micro-
powder metallurgy materials shall be documented in order to
structure of Fe-base materials may affect localized corrosion
evaluate the residual composition of additives that are present
resistance and absorption rate. Such inclusions may be classi-
after final powder consolidation and heat treatment processes.
fied according to Test Method E45 and/or Practice E1245 in
6.4 Physical:
order to allow assessment of their potential effect on localized
6.4.1 Magnetic permeability of metallic implant materials
corrosion resistance and absorption rate.
should be assessed to determine the potential for a magnetic
6.5.7 The presence of a cold worked, annealed, or thermally
response. The magnetic permeability is a function of the final
aged metallurgical condition shall be documented, since these
implant’s size, dimensions, and placement within the intended
factors influence the initial mechanical, physicochemical, and
application. The possibility of selective dealloying may occur
degradation properties.
during degradation and periodic magnetic permeability mea-
6.5.8 Metallographic etching methods, such as Practice
surements during in-vitro absorption testing may be used to
E407 or E340, may be used to detect decarburization (super-
determine nonmagnetic retention properties. The magnetic
ficial carbon oxidation) due to high-temperature thermal pro-
response of low-permeability materials may be measured in
cessing in order to evaluate compositional uniformity and the
...
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
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.
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
F3160 − 21
2. Referenced Documents
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 Requirements, for General Industrial Use
B69 Specification for Rolled Zinc
B80 Specification for Magnesium-Alloy Sand Castings
B86 Specification for Zinc and Zinc-Aluminum (ZA) Alloy Foundry and Die Castings
B90/B90M Specification for Magnesium-Alloy Sheet and Plate
B107/B107M Specification for Magnesium-Alloy Extruded Bars, Rods, Profiles, Tubes, and Wire
B199 Specification for Magnesium-Alloy Permanent Mold Castings
B403 Specification for Magnesium-Alloy Investment Castings
B557M Test Methods for Tension Testing Wrought and Cast Aluminum- and Magnesium-Alloy Products (Metric)
B661 Practice for Heat Treatment of Magnesium Alloys
B949 Specification for General Requirements for Zinc and Zinc Alloy Products
B953 Practice for Sampling Magnesium and Magnesium Alloys for Spectrochemical Analysis
B954 Test Method for Analysis of Magnesium and Magnesium Alloys by Atomic Emission Spectrometry
D3648 Practices for the Measurement of Radioactivity
E8/E8M Test Methods for Tension Testing of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E45 Test Methods for Determining the Inclusion Content of Steel
E112 Test Methods for Determining Average Grain Size
E290 Test Methods for Bend Testing of Material for Ductility
E340 Practice for Macroetching Metals and Alloys
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
E384 Test Method for Microindentation Hardness of Materials
E407 Practice for Microetching Metals and Alloys
E536 Test Methods for Chemical Analysis of Zinc and Zinc Alloys
E1245 Practice for Determining the Inclusion or Second-Phase Constituent Content of Metals by Automatic Image Analysis
E1382 Test Methods for Determining Average Grain Size Using Semiautomatic and Automatic Image Analysis
E1441 Guide for Computed Tomography (CT)
E2627 Practice for Determining Average Grain Size Using Electron Backscatter Diffraction (EBSD) in Fully Recrystallized
Polycrystalline Materials
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F629 Practice for Radiography of Cast Metallic Surgical Implants
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance
Environment
F2229 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless
Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F2393 Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
F2581 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel
Alloy Bar and Wire for Surgical Implants (UNS S29225)
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.
F3160 − 21
F2895 Practice for Digital Radiography of Cast Metallic Implants
F2902 Guide for Assessment of Absorbable Polymeric Implants
F3268 Guide for in vitro Degradation Testing of Absorbable Metals
IEEE/ASTM SI 10 American National Standard for Metric Practice
2.2 Aerospace Material Standards (AMS):
AMS 2248 Chemical Check Analysis Limits Corrosion and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
AMS 2630 Inspection, Ultrasonic Product Over 0.5 inch (12.7 mm) Thick
AMS 2632 Ultrasonic Inspection of Thin Materials
2.3 ISO Standards:
ISO 404 Steel and Steel Products—General Technical Delivery Requirements
ISO 643 Steels—Micrographic Determination of the Apparent Grain Size
ISO 3116 Magnesium and Magnesium Alloys—Wrought Magnesium Alloys—Fourth edition
ISO 3815-1 Zinc and Zinc Alloys—Part 1: Analysis of Solid Samples by Optical Emission Spectrometry
ISO 3815-2 Zinc and Zinc Alloys—Part 2: Analysis by Inductively Coupled Optical Emission Spectrometry
ISO 4967 Steel—Determination of Content of Nonmetallic Inclusions—Micrographic Method Using Standard Diagrams
ISO 6892-1 Metallic Materials—Tensile Testing—Part 1: Method of Test at Room Temperature
ISO 7800 Metallic materials—Wire—Simple torsion test
ISO 10993-15 Biological Evaluation of Medical Devices—Part 15: Identification and Quantification of Degradation Products
from Metals and Alloys
ISO 10993-17 Biological Evaluation of Medical Devices—Part 17: Establishment of Allowable Limits for Leachable Substances
ISO 10993-18 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Materials
ISO/TS 10993-19-Part 19 Physico-chemical, Morphological and Topographical Characterization of Materials
ISO 13067 Microbeam Analysis—Electron Backscatter Diffraction—Measurement of Average Grain Size
ISO 13485 Medical Devices Quality Management Systems—Requirements for Regulatory Purposes—Second edition
ISO 16220 Magnesium and Magnesium Alloys—Magnesium Alloy Ingots and Castings
ISO/TS 17137 Cardiovascular Implants and Extracorporeal Systems—Cardiovascular Absorbable Implants
ISO/TS 20721:2020 Implants for surgery—General guidelines and requirements for assessment of absorbable metallic implants
ISO 24173 Microbeam Analysis—Guidelines for Orientation Measurement Using Electron Backscatter Diffraction
ISO/TR 37137 Biological Evaluation of Medical Devices—Guidance for Absorbable Implants
ISO 9001 Quality Management Systems—Requirements
3. Terminology
3.1 Definitions:
3.1.1 absorbable, adj—in the body, an initially distinct foreign material or substance that either directly or through intended
degradation can pass through or be metabolized or assimilated by cells and/or tissue. F2902
4. Summary of Guide
4.1 Novel absorbable metallic implant materials that do not yet have industry standards are being developed for use in applications
such as cardiovascular, orthopedic, general surgical, and diagnostic. The lack of a standard guide for the metallurgical
characterization of these new materials may contribute to material property non-uniformity which could create variation in the
observed performance of the final product. It is the intent of this guide to provide material property information, corresponding
test methods, and relevant medical product standards to serve as a guide for the metallurgical characterization of new or modified
materials. These guidelines are tabulated to assist with the development of specifications for new or modified absorbable metallic
materials.
4.2 This guide is focused on providing a characterization scheme for materials prior to their fabrication into a finished medical
implant. The characterization and testing of absorbable metallic materials after they have been manufactured into finished and
sterilized medical implants will depend on the design, mass, shape, anatomic location, and end-use application.
5. Significance and Use
5.1 The metallurgical properties of materials used to manufacture absorbable metallic implants can influence biological reactions
Available from SAE International (SAE), 400 Commonwealth Dr., Warrendale, PA 15096, http://www.sae.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
F3160 − 21
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.
6. Characterization
6.1 Overview:
6.1.1 The metallurgical characterization of absorbable metallic materials includes the influence of chemical, microstructural,
physical, mechanical, and mechanicaldegradation properties in addition to material inspection methods that are utilized to
document initial material quality and uniformity.
6.1.2 This metallurgical characterization guide will focus on magnesium (Mg)-base, iron (Fe)-base, and zinc (Zn)-base alloys
since these are the main classes of metallic materials that have been documented in the literature for potential absorbable metallic
implant applications. This guide may be applicable to other absorbable alloy systems.
6.1.3 The below described evaluations are general in their scope, with additional unlisted material assessments potentially needed
to address the performance requirements of a specific implant application.
6.2 General:
6.2.1 General requirements are specified in Specifications B90/B90M and B107/B107M for wrought Mg-base product forms;
Specifications A480/A480M, A484/A484M, and A555/A555M for wrought Fe-base product forms; and Specification B949 for
Zn-base product forms.
6.2.2 Requirements are specified in Specification B403 for Mg-base castings; Specification A957 for Fe-base castings; and
Specification B86 for Zn-base castings.
6.3 Chemical:
6.3.1 Some examples of absorbable Mg compositions that have been investigated to date include pure Mg, conventional Mg
alloys, and experimental Mg alloys containing combinations of aluminum (Al), calcium (Ca), lithium (Li), manganese (Mn),
neodymium (Nd), rare earth (RE), silver (Ag), yttrium (Y), zinc (Zn), or zirconium (Zr).
6.3.2 Some examples of absorbable Fe compositions that have been investigated to date include pure Fe, a range of Fe-Mn alloys
with and without silicon (Si) or palladium (Pd), and novel binary Fe compositions containing either aluminum (Al), boron (B),
carbon,carbon (C), cobalt (Co), sulfur (S), or tungsten (W).
6.3.3 Some examples of absorbable Zn compositions that have been investigated to date include pure Zn, commercial Zn alloys,
and binary Zn-Mg combinations.
6.3.4 Relevant technical information has been published for the majority of the absorbable alloy compositions documented in
6.3.1 and 6.3.2.
6.3.5 Elemental concentrations present at specified major, minor, residual, or trace levels are defined in Test Method A751 and
ISO 3116. Within this context, a trace classification does not include elements that are a specified component of the alloy,
regardless of concentration.
NOTE 1—For the materials covered by this standard, no biocompatibility assessment is required since this standard focuses on characterization of materials
that are subject to further fabrication into a final device. However, since the overall composition of any absorbable implant can be expected to have a
significant impact on its biocompatibility, the entire composition of materials covered by this standard (including the intended composition, metallic
degradation species, and any residual or trace metallic or non-metallicnonmetallic impurities) should be preliminarily assessed for their potential impact
on any later ISO 10993 risk assessment of the final device. In addition to the ISO 10993 series, additional supplemental guidance specific for the biological
evaluation of absorbable implants can be found in ISO TR37137.
Hendra Hermawan, Biodegradable Metals from Concept to ApplicationsBiodegradable Metals from Concept to Applications, , Spinger, 2012, ISSN 2192-1091; ISSN
2192- 1105 2192-1105 (electronic).
F3160 − 21
6.3.6 Chemical analysis may be performed according to Test Method E354 for Fe-base materials, Test Method B954 for Mg-base
materials, and Test Method E536 for Zn-base materials.
6.3.7 Chemical check analysis tolerance limits specified in AMS 2248 may be used to verify heat analysis of Fe-base materials.
6.3.8 Rare earth (RE) elements include the fifteen lanthanide elements (atomic number 57 to 71) plus the transition metals
scandium (Sc) and yttrium (Y).
6.3.9 Processing aids and binders that may be used with powder metallurgy materials shall be documented in order to evaluate
the residual composition of additives that are present after final powder consolidation and heat treatment processes.
6.4 Physical:
6.4.1 Magnetic permeability of metallic implant materials should be assessed to determine the potential for a magnetic response.
The magnetic permeability is a function of the final implant’s size, dimensions, and placement within the intended application. The
possibility of selective dealloying may occur during degradation and periodic magnetic permeability measurements during in-vitro
absorption testing may be used to determine nonmagnetic retention properties. The magnetic response of low permeability
low-permeability materials may be measured in accordance with Test Method A342/A342M.
6.4.2 The minerals and any ensuing extraction and refining process should be assessed for the potential presence of radioactivity
in the absorbable metallic device. If the assessment determines that a risk of potentially significant radioactive carryover is present,
the radioactivity, defined as the sum of the mass activity of U238, Ra226, and Th232, as determined by γ-spectroscopy on the
material, should meet the suggested limits of ASTMSpecification F2393, unless justified otherwise. Radioactivity measurements
may be conducted according to Practice D3648.
6.5 Microstructural:
6.5.1 Microstructural features will primarily depend on the chemical composition and the level of processing (e.g. (for example,
whether the material is wrought or cast).
6.5.2 Wrought materials may exhibit a refined microstructure and the grain size should be evaluated and reported according to Test
Method E112 as equiaxed, uniform, mixed, or duplex. If analytically beneficial, a more precise grain boundary determination
should be considered through utilization of one of the electron backscatter diffraction (EBSD) methods that are described in ASTM
Test Method E1382, Practice E2627, and ISO 13067, all of which are suited for both cast and wrought alloys.
6.5.3 Casting alloy is usually in the form of shot, bar, or ingots and may exhibit lamellar, dendritic, and/or equiaxed
microstructural characteristics after melting into castings followed by heat treating.
6.5.4 Metastable martensitic phase transformations such as (γFe,γMn → α') may occur in specific Fe-Mn compositions during cold
working and magnetic permeability measurements may be used to verify nonmagnetic stability.
6.5.5 A magnetic surface layer may be formed on high manganese (Mn) containing alloys as a result of thermal oxidation of Mn
during hot working or annealing operations and may increase the magnetic permeability. The magnetic surface layer shall be
removed from the finished product prior to its use as a medica
...
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