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ASTM F620-20

(Specification)

Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

ABSTRACT
This specification covers alpha plus beta titanium alloy forgings for use in surgical implants such as orthopaedic medical devices. The products should be forged by hammering, pressing, extruding, or upsetting bars or wires and should be free of splits, scales, cracks, flaws, and other imperfections. After hot forging, each product should be subjected to annealing treatment consisting of heating the parts to an appropriate temperature and followed by cooling. Samples should be tested according to the specified procedure and should conform to the required values for chemical composition, tensile strength, hardness, elongation, and area reduction.
SCOPE
1.1 This specification covers the requirements for titanium alloy forgings for surgical implants, in the alpha plus beta condition, when the material forged conforms to Specifications F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS R56400), or F2066 (UNS R58150).  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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 nonconformance with the standard.  
1.3 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.  
1.4 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-2020
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

Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-Feb-2020

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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: F620 −20
Standard Specification for
Titanium Alloy Forgings for Surgical Implants in the Alpha
1
Plus Beta Condition
ThisstandardisissuedunderthefixeddesignationF620;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E18 Test Methods for Rockwell Hardness of Metallic Ma-
terials
1.1 This specification covers the requirements for titanium
E29 Practice for Using Significant Digits in Test Data to
alloy forgings for surgical implants, in the alpha plus beta
Determine Conformance with Specifications
condition, when the material forged conforms to Specifications
E92 Test Methods for Vickers Hardness and Knoop Hard-
F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS
ness of Metallic Materials
R56400), or F2066 (UNS R58150).
E165 Practice for Liquid Penetrant Testing for General
1.2 The SI units in this standard are the primary units. The
Industry
values stated in either primary SI units or secondary inch-
E539 Test Method for Analysis of Titanium Alloys by
pound units are to be regarded separately as standard. The
WavelengthDispersiveX-RayFluorescenceSpectrometry
values stated in each system may not be exact equivalents;
E1409 Test Method for Determination of Oxygen and Nitro-
therefore,eachsystemshallbeusedindependentlyoftheother.
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
Combining values from the two systems may result in noncon-
E1447 Test Method for Determination of Hydrogen in Tita-
formance with the standard.
nium and Titanium Alloys by Inert Gas Fusion Thermal
1.3 This standard does not purport to address all of the
Conductivity/Infrared Detection Method
safety concerns, if any, associated with its use. It is the
E2371 Test Method for Analysis of Titanium and Titanium
responsibility of the user of this standard to establish appro-
Alloys by Direct Current Plasma and Inductively Coupled
priate safety, health, and environmental practices and deter-
Plasma Atomic Emission Spectrometry (Performance-
mine the applicability of regulatory limitations prior to use.
Based Test Methodology)
1.4 This international standard was developed in accor-
E2994 Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
AlloysbySparkAtomicEmissionSpectrometryandGlow
ization established in the Decision on Principles for the
Discharge Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Method)
mendations issued by the World Trade Organization Technical
F67 Specification for Unalloyed Titanium, for Surgical Im-
Barriers to Trade (TBT) Committee.
plant Applications (UNS R50250, UNS R50400, UNS
2. Referenced Documents
R50550, UNS R50700)
2
F136 Specification for Wrought Titanium-6Aluminum-
2.1 ASTM Standards:
E8/E8M Test Methods for Tension Testing of Metallic Ma- 4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
terials Implant Applications (UNS R56401)
E10 Test Method for Brinell Hardness of Metallic Materials
F601 Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
1
F1295 Specification for Wrought Titanium-6Aluminum-
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
7Niobium Alloy for Surgical Implant Applications (UNS
Subcommittee F04.12 on Metallurgical Materials.
R56700)
Current edition approved Feb. 1, 2020. Published March 2020. Originally
F1472 Specification for Wrought Titanium-6Aluminum-
approvedin1979.Lastpreviouseditionapprovedin2015asF620 – 11(2015).DOI:
10.1520/F0620-20. 4VanadiumAlloy for Surgical ImplantApplications (UNS
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
R56400)
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F2066 Specification for Wrought Titanium-15 Molybdenum
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Alloy for Surgical Implant Applications (UNS R58150)
*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 ----------------------
F620 − 20
IEEE/ASTM SI 10 American National Standard for the Use be determined and confirmed by the forger, and shall meet the
of the International System of Units (SI): The Modern product check analys
...

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: F620 − 11 (Reapproved 2015) F620 − 20
Standard Specification for
Titanium Alloy Forgings for Surgical Implants in the Alpha
1
Plus Beta Condition
This standard is issued under the fixed designation F620; 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*
1.1 This specification covers the requirements for titanium alloy forgings for surgical implants, in the alpha plus beta condition,
when the material forged conforms to Specifications F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS R56400), or F2066
(UNS R58150).
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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-conformancenonconformance
with the standard.
1.3 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.
1.4 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E8/E8M Test Methods for Tension Testing of Metallic Materials
E10 Test Method for Brinell Hardness 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
E92 Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E165 Practice for Liquid Penetrant Testing for General Industry
E539 Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E2371 Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma
Atomic Emission Spectrometry (Performance-Based Test Methodology)
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Dec. 1, 2015Feb. 1, 2020. Published December 2015March 2020. Originally approved in 1979. Last previous edition approved in 20112015 as
F620 – 11.F620 – 11(2015). DOI: 10.1520/F0620-11R15.10.1520/F0620-20.
2
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.
*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 ----------------------
F620 − 20
F1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F2066 Specification for Wrought Titanium-15 Mol
...

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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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ASTM
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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