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ASTM F1472-99

(Specification)

Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications

Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications

SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium alloy (UNS R56400) to be used in the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are provided for information only.
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 and health practices and to determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
09-Nov-2000
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

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ASTM F1472-99 - Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant ApplicationsASTM F1472-99 - Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
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ASTM F1472-99 - Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy (UNS R56400) for Surgical Implant Applications
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1472 – 99
Standard Specification for
Wrought Titanium - 6Aluminum - 4Vanadium Alloy for
1
Surgical Implant Applications (UNS R56400)
This standard is issued under the fixed designation F 1472; 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.
8
1. Scope Quality Control Program
2.3 Aerospace Material Specifications:
1.1 This specification covers the chemical, mechanical, and
AMS 4928L Titanium Alloy Bars, Forgings and Rings
metallurgical requirements for wrought annealed titanium -
9
6Al-4V
6aluminum -4vanadium alloy (UNS R56400) standard grade
AMS 2249C Chemical Check Analysis Limits, Titanium
titanium alloy to be used in the manufacture of surgical
9
and Titanium Alloys
implants.
2.4 Society of Automotive Engineers Standard:
1.2 The values stated in inch-pound units are to be regarded
SAE J1086 Practice for Numbering Metals and Alloys
as the standard. The metric equivalents in parentheses are
9
(UNS)
provided for information only.
3. Product Classification
2. Referenced Documents
3.1 strip—any product under 0.1875 in. (4.76 mm in thick-
2.1 ASTM Standards:
ness and under 24 in. (610 mm) wide.
F 136 Specification for Wrought Titanium 6Sl-4V ELl
2
3.2 sheet—any product under 0.1875 in. (4.76 mm) in
Alloy for Surgical Implant Applications
thickness and 24 in. (610 mm) or more in width.
B 265 Specification for Titanium and Titanium Alloy Strip,
3
3.3 plate—any product 0.1875 in. (4.76 mm) thick and over
Sheet and Plate
and 10 in. (254 mm) wide and over, with widths greater than
B 348 Specification for Titanium and Titanium Alloy Bil-
3
five times thickness. Plate up to 4.00 in. (101.60 mm), thick
lets
inclusive is covered by this specification.
B 381 Specification for Titanium and Titanium Alloy Forg-
3
3.4 bar—rounds from 0.1875 in. (7.9 mm) to 4.00 in.
ings
4
(101.60 mm) in diameter. (Other sizes by special order.)
E 8 Test Methods of Tension Testing of Metallic Materials
3.5 forging bar— bar as described in 3.4, used for produc-
E 120 Test Methods for Chemical Analysis of Titanium and
5
tion of forgings, may be furnished in the hot rolled condition.
Titanium Alloys
3.6 wire—rounds less than 0.1875 in. (4.76 mm) in diam-
E 290 Test Method for Semi-Guided Bend Test for Ductility
4
eter.
of Metallic Materials
6
E 527 Practice for Numbering Metals and Alloys (UNS)
4. Ordering Information
E 1409 Test Method for Determination of Oxygen in Tita-
4.1 Inquiries and orders for material under this specification
nium and Titanium Alloys by the Inert Gas Fusion Tech-
5 shall include the following information:
nique
4.1.1 Quantiy (weight or number of pieces),
E 1447 Test Method for Determination of Hydrogen in
4.1.2 Applicable ASTM designation,
Titanium Alloys by the Inert Gas Fusion Thermal Conduc-
7 4.1.3 Form (sheet, strip, plate, wire, bar, or forging),
tivity Method
4.1.4 Condition (see 5.1),
2.2 Other Standards:
4.1.5 Mechanical properties (if applicable, for special con-
ASQC C1 Specifications of General Requirements for a
ditions),
4.1.6 Finish (see 5.2),
1
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
4.1.7 Applicable dimensions including size, thickness,
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
width, or print number,
F04.02 on Resources.
4.1.8 Special tests, and
Current edition approved Feb. 10, 1999. Published June 1999. Originally
published as F1472–93. Last previous edition F1472–93. 4.1.9 Special requirements
2
Annual Book of ASTM Standards, Vol 13.01.
3
Annual Book of ASTM Standards, Vol 02.04.
4 8
Annual Book of ASTM Standards, Vol 0301. Available from American Society for Quality Control, 161 W. Wisconsin Ave.,
5
Annual Book of ASTM Standards, Vol 03.05. Milwaukee, WI 53203.
6 9
Annual Book of ASTM Standards, Vol 01.01. Available from the Society of Automotive Engineers, 3001 W. Big Beaver,
7
Annual Book of ASTM Standards, Vol 03.06. Troy, MI 48084.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F 1472
A
TABLE 2 Permissible Variation in Product Analysis Tolerance
5. Materials and Manufacture
Element Variation Under Min or Over Max
5.1 The various titanium mill products covered in this
Nitrogen 0.02
specification are normally formed with the conventional forg-
Carbon 0.02
ing and rolling equipment found in primary ferrous and
Hydrogen 0.002
non-ferrous plants. The ingot metal for such mill operations is
Iron 0.10
Oxygen 0.02
usually melted in non consumable, plasma, EB or arc furnaces
Aluminum 0.04
of a type conventio
...

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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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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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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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1.1 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.  
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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

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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.

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    English language
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