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ASTM F67-13(2017)

(Specification)

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strips, sheets, plates, bars, billets, forgings, and wires used for the manufacture of surgical implants. The four grades identified here are defined as follows: Grade 1—UNS R50250; Grade 2—UNS R50400; Grade 3—UNS R50550; and Grade 4—UNS R50700. Mill products may be supplied with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish, or as specified by the purchaser. Materials shall be furnished in the hotworked, cold-worked, forged, annealed, or stress-relieved condition. Mechanical properties to which the titanium materials shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strip, sheet, plate, bar, billet, forging, and wire used for the manufacture of surgical implants.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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
Published
Publication Date
28-Feb-2017
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

Relations

Refers
ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
Effective Date
01-Feb-2015
Refers
ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
Effective Date
15-Jul-2016
Refers
ASTM B265-15 - Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate
Effective Date
01-Nov-2015
Refers
ASTM B265-20 - Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate
Effective Date
01-Jan-2020
Refers
ASTM B265-20a - Standard Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate
Effective Date
01-Apr-2020
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses
Effective Date
01-Mar-2017
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
01-Mar-2017
Referred By
ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
Effective Date
01-Mar-2017
Referred By
ASTM F2384-10(2016) - Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
Effective Date
01-Mar-2017
Referred By
ASTM F1580-18 - Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
Effective Date
01-Mar-2017
Referred By
ASTM F2989-21 - Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
Effective Date
01-Mar-2017
Referred By
ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Mar-2017
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Mar-2017
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Mar-2017
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
01-Mar-2017
Referred By
ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
Effective Date
01-Mar-2017
Referred By
ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Effective Date
01-Mar-2017
Referred By
ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
Effective Date
01-Mar-2017
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis
Effective Date
01-Mar-2017
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Mar-2017
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Mar-2017
Referred By
ASTM F647-22 - Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Effective Date
01-Mar-2017
Referred By
ASTM F2066-23 - Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
Effective Date
01-Mar-2017

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ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
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ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
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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:F67 −13 (Reapproved 2017)
Standard Specification for
Unalloyed Titanium, for Surgical Implant Applications (UNS
1
R50250, UNS R50400, UNS R50550, UNS R50700)
ThisstandardisissuedunderthefixeddesignationF67;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
1.1 This specification covers the chemical, mechanical, and
E1447Test Method for Determination of Hydrogen in Tita-
metallurgical requirements for four grades of unalloyed tita-
nium and Titanium Alloys by Inert Gas Fusion Thermal
nium strip, sheet, plate, bar, billet, forging, and wire used for
Conductivity/Infrared Detection Method
the manufacture of surgical implants.
E1941Test Method for Determination of Carbon in Refrac-
1.2 The values stated in either SI units or inch-pound units
toryandReactiveMetalsandTheirAlloysbyCombustion
are to be regarded separately as standard. The values stated in
Analysis
each system may not be exact equivalents; therefore, each
E2371Test Method for Analysis of Titanium and Titanium
system shall be used independently of the other. Combining
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
values from the two systems may result in non-conformance
Plasma Atomic Emission Spectrometry (Performance-
with the standard.
Based Test Methodology)
1.3 This international standard was developed in accor-
E2626Guide for Spectrometric Analysis of Reactive and
dance with internationally recognized principles on standard- Refractory Metals
ization established in the Decision on Principles for the
F981Practice for Assessment of Compatibility of Biomate-
Development of International Standards, Guides and Recom- rials for Surgical Implants with Respect to Effect of
mendations issued by the World Trade Organization Technical
Materials on Muscle and Insertion into Bone
Barriers to Trade (TBT) Committee. IEEE/ASTM SI 10American National Standard for Metric
Practice
3
2. Referenced Documents
2.2 Aerospace Material Specification:
2
AMS 2249Chemical Check Analysis Limits, Titanium and
2.1 ASTM Standards:
Titanium Alloys
B265Specification for Titanium and Titanium Alloy Strip,
AMS 2380Approval and Control of Premium Quality Tita-
Sheet, and Plate
nium Alloys
B348Specification for Titanium and Titanium Alloy Bars
AMS 2631Ultrasonic Inspection TitaniumAlloy Bar, Billet
and Billets
and Plate
B381Specification for Titanium and Titanium Alloy Forg-
2.3 ISO Standards:
ings
ISO 5832-2Implants for Surgery—Metallic Materials—
E8/E8MTest Methods for Tension Testing of Metallic Ma-
4
Unalloyed Titanium
terials
ISO 6892Metallic Materials—Tensile Testing at Ambient
E29Practice for Using Significant Digits in Test Data to
4
Temperature
Determine Conformance with Specifications
4
ISO 9001Quality Management Systems
E290Test Methods for Bend Testing of Material for Ductil-
ity
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
1
This specification is under the jurisdiction of ASTM Committee F04 on
3.1.1 lot, n—the total number of mill products produced
Medical and Surgical Materials and Devices and is the direct responsibility of
from the same melt heat under the same conditions at essen-
Subcommittee F04.12 on Metallurgical Materials.
tially the same time.
Current edition approved March 1, 2017. Published April 2017. Originally
approved in 1966. Last previous edition approved in 2013 as F67–13. DOI:
10.1520/F0067-13R17.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203.
*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 ----------------------
F67−13 (2017)
A
TABLE 2 Product Analysis Tolerances
3.1.2 cold work, n—any mechanical deformation process
Limit or Maximum of Tolerance Under the
performed below the recrystallization temperature which re-
Element Specified Range %, Minimum or Over the
sults in strain hardening of the material.
B
(mass/mass) Maximum
...

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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.
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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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.  
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ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. 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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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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