ASTM F3160-16

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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Mar-2016
• 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

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: F3160 − 16
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 such as ceramics or polymers. However, this standard does
apply to absorbable metallic materials, regardless of the
1.1 This guidance document provides metallurgical charac-
presence or absence of a coating.
terization information that may be beneficial in the evaluation
1.7 This standard does not purport to address all of the
of absorbable metallic materials intended for medical implant
safety concerns, if any, associated with its use. It is the
applications. This guide is primarily intended for absorbable
responsibility of the user of this standard to establish appro-
metallic materials that undergo further processing into a
priate safety and health practices and determine the applica-
fabricated final device. Therefore, this standard does not
bility of regulatory limitations prior to use.
require assessments that are more appropriately conducted on
the final device, such as biological evaluation. However, a few
2. Referenced Documents
relevant standards for finished implant devices are included for
2
2.1 ASTM Standards:
information purposes.
A262 Practices for Detecting Susceptibility to Intergranular
1.2 The purpose of this guide is to identify appropriate test
Attack in Austenitic Stainless Steels
methods and relevant medical product standards that can be
A342/A342M Test Methods for Permeability of Weakly
used to develop future standards for new or modified absorb-
Magnetic Materials
able metallic materials.
A480/A480M Specification for General Requirements for
1.3 This guide is not intended to cover other major classes
Flat-Rolled Stainless and Heat-Resisting Steel Plate,
of absorbable materials such as polymers, ceramics,
Sheet, and Strip
composites, and tissue-engineered materials.
A484/A484M Specification for General Requirements for
Stainless Steel Bars, Billets, and Forgings
1.4 This standard guide is focused on the chemical,
A555/A555M Specification for General Requirements for
physical, microstructural, and mechanical properties plus in-
Stainless Steel Wire and Wire Rods
spection guidelines for metallic materials that are used for
A751 Test Methods, Practices, and Terminology for Chemi-
medical implants designed to be absorbed in the body over a
cal Analysis of Steel Products
period of time. This guide focuses on material characteriza-
A957 SpecificationforInvestmentCastings,SteelandAlloy,
tions and does not address device specific mechanical testing
Common Requirements, for General Industrial Use
that may be necessary to determine safety and functionality of
B69 Specification for Rolled Zinc
the implant.
B80 Specification for Magnesium-Alloy Sand Castings
1.5 Compliance with materials specifications developed in
B86 Specification for Zinc and Zinc-Aluminum (ZA) Alloy
accordance with this standard may not necessarily result in a
Foundry and Die Castings
material suitable for its intended purpose. Additional testing
B90/B90M Specification for Magnesium-Alloy Sheet and
specific to the intended use may be required.
Plate
1.6 Since surface modifications of medical implants are
B107/B107M Specification for Magnesium-Alloy Extruded
generally applied in the latter stages of manufacturing, this
Bars, Rods, Profiles, Tubes, and Wire
standard guide does not cover the characterization of either
B199 Specification for Magnesium-Alloy Permanent Mold
absorbable or non-absorbable surface coatings that are metallic
Castings
in origin such as oxides or from the addition of other materials
B403 Specification for Magnesium-Alloy Investment Cast-
ings
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
2
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.12 on Metallurgical Materials. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved April 1, 2016. Published May 2016. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F3160–16. the ASTM website.
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F3160 − 16
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