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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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, Practices, and Terminology for Chemical Analysis of Steel Products
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) Imaging
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)
F2902 Guide for Assessment of Absorbable Polymeric Implants
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
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3160-16, Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants, ASTM International, West Conshohocken, PA, 2016, www.astm.orgBack to Top