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ASTM F1108-04

(Specification)

Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for cast titanium-6aluminum-4vanadium alloy (UNS R56406). Castings conforming to this specification shall be produced by vacuum investment casting. Castings covered by this specification shall be in the annealed and hot isostatically pressed condition. Product castings shall conform to the requirements prescribed. Material supplied under this specification shall conform to the mechanical property requirements prescribed. Chemical analysis, product analysis, tension tests, fluorescent penetrant examination, and radiographic examination shall be performed to meet the specified requirements.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for cast titanium-6aluminum-4vanadium alloy (UNS R56406).
1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of inch-pound units may be approximate.

General Information

Status
Historical
Publication Date
31-Mar-2004
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

Replaces
ASTM F1108-02 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
Effective Date
01-Apr-2004
Replaced By
ASTM F1108-04(2009) - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
Effective Date
01-Apr-2009
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Apr-2004
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-Apr-2004
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
01-Apr-2004
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
01-Apr-2004
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
01-Apr-2004
Referred By
ASTM F2885-17(2023) - Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications
Effective Date
01-Apr-2004
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
01-Apr-2004
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
01-Apr-2004
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Apr-2004

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ASTM F1108-04 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)ASTM F1108-04 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
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ASTM F1108-04 - Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
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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: F 1108 – 04
Standard Specification for
Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical
1
Implants (UNS R56406)
This standard is issued under the fixed designation F 1108; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope* 2.3 Aerospace Material Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and
1.1 This specification covers the chemical, mechanical, and
5
Titanium Alloys
metallurgical requirements for cast titanium-6aluminum-
2.4 American Society for Quality Standard:
4vanadium alloy (UNS R56406).
ASQ C1 Specification of General Requirements for a Qual-
1.2 The values stated in inch-pound units are to be regarded
6
ity Control Program
as the standard.The SI equivalents of inch-pound units may be
2.5 Society of Automotive Engineers:
approximate.
SAE J1086 Practice for Numbering Metals and Alloys
5
2. Referenced Documents
(UNS)
2
2.1 ASTM Standards:
3. Ordering Information
B 600 Guide for Descaling and Cleaning Titanium and
3.1 Inquiries and orders for material under this specification
Titanium Alloy Surfaces
shall include the following information:
E 8 Test Methods for Tension Testing of Metallic Materials
3.1.1 Quantity,
E 120 Test Methods for ChemicalAnalysis of Titanium and
3
3.1.2 ASTM designation and issue date,
Titanium Alloys
3.1.3 Applicable dimensions or drawing number,
E 165 Test Method for Liquid Penetrant Examination
3.1.4 Condition (see 4.1 and 4.2),
E 1409 Test Method for Determination of Oxygen in Tita-
3.1.5 Finish (see 4.4 and 4.5),
nium and Titanium Alloys by the Inert Gas Fusion Tech-
3.1.6 Special tests (see Section 7),
nique
3.1.7 Other requirements.
E 1447 Test Method for Determination Hydrogen in Tita-
niumandTitaniumAlloysbytheInertGasFusionThermal
4. Materials and Manufacture
Conductivity Method
4.1 Castings conforming to this specification shall be pro-
F 136 Specification for Wrought Titanium-6Aluminum-
duced by vacuum investment casting.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
4.2 Castings covered by this specification shall be in the
Implant Applications (UNS R56401)
annealed and hot isostatically pressed condition.
F 601 Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
NOTE 1—Whilehotisostaticprocessing(HIP)mayenhancemechanical
F 629 Practice for Radiography of Cast Metallic Surgical properties of Ti6A1-4V castings, it has also been shown to reduce the
scatter in mechanical properties and therefore increases the confidence in
Implants
reliability of castings.
2.2 ISO Standard:
ISO 6892 Metallic Materials—Tensile Testing at Ambient 4.3 Surface defects may be repaired by welding.
4
Temperature
4.3.1 Weld repair shall be carefully executed as per written
procedures by individuals qualified to perform those proce-
dures.
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.3.2 ELI weld rod conforming to Specification F 136 shall
Medical and Surgical Materials and Devices and is the direct responsibility of
be used where filler metal is needed.
Subcommittee F04.12 on Metallurgical Materials.
4.3.3 Weld repairs shall be performed prior to final thermal
Current edition approved Apr. 1, 2004. Published April 2004. Originally
approved in 1988. Last previous edition approved in 2002 as F 1108 - 02.
processing.
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
5
the ASTM website. AvailablefromSocietyofAutomotiveEngineers,Inc.,400CommonwealthDr.,
3
Withdrawn. Warrendale, PA 15096-0001.
4 6
Available from American National Standards Institute, 25 W. 43rd St., 4th Available from American Society for Quality, 600 N. Plankinton Ave.,
Floor, New York NY 10036. 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 ----------------------
F1108–04
A
NOTE 2—Under certain circumstances, a weld repair will act as a stress TABLE 2 Product Analysis Tolerances
riser. Therefore, care should be exercised in the location and extent of
Tolerance Under the Minimum or
Element
B
weld repair as it relates to regions of the implant where significant stresses
Over the Maximum Limit % (mass/mass)
might be incurred.
Nitrogen 0.02
Carbon 0.02
4.4 All alpha case shall be removed by suitable means such
Hydrogen 0.0030
as chemical milling or machining pri
...

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SCOPE
1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
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ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
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SIGNIFICANCE AND USE
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SCOPE
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.  
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1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2.  
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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
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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.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
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1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
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).  
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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.  
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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 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.

  • Guide
    8 pages
    English language
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  • Guide
    8 pages
    English language
    sale 15% off