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ASTM F2146-07

(Specification)

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. The mill product shall be furnished as descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished. Conditions for annealing, cold-working and stress relieving, and surface cleanliness are specified. Heat analysis shall conform to the chemical composition requirements prescribed for: nitrogen, carbon, hydrogen, iron, oxygen, aluminum, vanadium, yttrium, and titanium. The material shall conform to the mechanical property requirements specified for: ultimate tensile strength, yield strength, and elongation. Requirements for tension testing, microstructure, ultrasonic testing, and longitudinal and transverse notch machining are specified as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought and annealed or cold-worked and stress-relieved titanium-3aluminum-2.5vanadium alloy (UNS R56320) seamless tubing to be used in the manufacture of surgical implants. See Section for size limitations.
1.2 The values stated in inch pound units are to be regarded as the standard. The SI equivalents in parentheses are for information only.
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 requirements prior to use.

General Information

Status
Historical
Publication Date
31-Jan-2007
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 F2146-01 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
Effective Date
01-Feb-2007

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ASTM F2146-07 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)ASTM F2146-07 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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ASTM F2146-07 - Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
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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:F2146 −07
StandardSpecification for
Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless
1
Tubing for Surgical Implant Applications (UNS R56320)
This standard is issued under the fixed designation F2146; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* F1472 Specification for Wrought Titanium-6Aluminum-
4VanadiumAlloyforSurgicalImplantApplications(UNS
1.1 This specification covers the chemical, mechanical, and
R56400)
metallurgical requirements for wrought and annealed or cold-
3
2.2 Aerospace Material Specifications:
worked and stress-relieved titanium-3aluminum-2.5vanadium
AMS2244Tolerances,TitaniumandTitaniumAlloyTubing
alloy (UNS R56320) seamless tubing to be used in the
AMS 2249Chemical Check Analysis Limits, Titanium and
manufacture of surgical implants. See Section 4 for size
Titanium Alloys
limitations.
AMS 2634Ultrasonic Inspection, Thin Wall Metal Tubing
1.2 The values stated in inch pound units are to be regarded
AMS 4943Titanium Alloy, Seamless, Hydraulic Tubing,
as the standard. The SI equivalents in parentheses are for
3.0A1-2.5VAnnealed
information only.
AMS 4944Titanium Alloy, Seamless, Hydraulic Tubing,
1.3 This standard does not purport to address all of the 3.0A1-2.5V Cold-Worked, Stress-Relieved
safety concerns, if any, associated with its use. It is the
AMS 6940Titanium Alloy Bars, Forgings, and Forging
responsibility of the user of this standard to establish appro- Stock, 3.0Al-2.5VAnnealed-UNS R56320
4
priate safety and health practices and determine the applica-
2.3 American Society for Quality Standard:
bility of regulatory requirements prior to use. ASQC1SpecificationsofGeneralRequirementsforaQual-
ity Program
5
2. Referenced Documents
2.4 ISO Standards:
2
ISO 6892Metallic Materials Tensile Testing at Ambient
2.1 ASTM Standards:
Temperature
E8Test Methods for Tension Testing of Metallic Materials
ISO 9001Quality Management Systems Requirements
E29Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
3. Terminology
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and Titanium Alloys by the Inert Gas 3.1 Definitions of Terms Specific to This Standard:
3.1.1 beta transus, n—the minimum temperature at which
Fusion Technique
E1447Test Method for Determination of Hydrogen in Tita- thealphaplusbetaphasecantransformto100%betaphaseon
heating.
nium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
3.1.2 cold work, n—any mechanical deformation process
E2371Test Method for Analysis of Titanium and Titanium
performed below the recrystallization temperature which re-
Alloys by Atomic Emission Plasma Spectrometry
sults in strain hardening of the material.
F136 Specification for Wrought Titanium-6Aluminum-
3.1.3 lot, n—total number of tubes produced from the same
4VanadiumELI(ExtraLowInterstitial)AlloyforSurgical
heat under the same conditions at essentially the same time.
Implant Applications (UNS R56401)
4. Product Classification
1 4.1 Tubing—Tubular product with an outside diameter
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of greater than 0.250 in. (6.35 mm).
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Feb. 1, 2007. Published February 2007. Originally
3
approved in 2001. Last previous edition approved in 2001 as F2146–01. DOI: Available from Society of Automotive Engineers (SAE), 400 Commonwealth
10.1520/F2146-07. Dr., Warrendale, PA 15096-0001, http://www.sae.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Milwaukee, WI 53203, http://www.asq.org.
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
*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 ----------------------
F2146−07
TABLE 1 Chemical Requirements
5. Ordering Information
Composition, % (mass/mass)
5.1 Include with inquiries and orders for material under this
Element
Minimum Maximum
specification the following information:
Nitrogen . . . 0.020
5.1.1 Quantity,
Carbon . . . 0.050
5
...

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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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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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1.6 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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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