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ASTM F620-06

(Specification)

Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants

Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants

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 alpha plus beta titanium alloy forgings for surgical implants when the material forged conforms to Specifications F 136 (UNS R56401), F 1295 (UNS R56700), or F 1472 (UNS R56400).
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.

General Information

Status
Historical
Publication Date
30-Apr-2006
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 F620-00 - Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
Effective Date
01-May-2006
Replaced By
ASTM F620-11 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
Effective Date
01-Dec-2011
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
01-May-2006
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
01-May-2006
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
01-May-2006

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ASTM F620-06 - Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical ImplantsASTM F620-06 - Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
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ASTM F620-06 - Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
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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: F620 – 06
Standard Specification for
Alpha Plus Beta Titanium Alloy Forgings for Surgical
1
Implants
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* 4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
Implant Applications (UNS R56401)
1.1 Thisspecificationcoverstherequirementsforalphaplus
F601 Practice for Fluorescent Penetrant Inspection of Me-
beta titanium alloy forgings for surgical implants when the
tallic Surgical Implants
material forged conforms to Specifications F136 (UNS
F1295 Specification for Wrought Titanium-6Aluminum-
R56401), F1295 (UNS R56700), or F1472 (UNS R56400).
7Niobium Alloy for Surgical Implant Applications (UNS
1.2 The values stated in inch-pound units are to be regarded
R56700)
as the standard. The SI equivalents in parentheses are for
F1472 Specification for Wrought Titanium-6Aluminum-
information only.
4Vanadium Alloy for Surgical Implant Applications (UNS
2. Referenced Documents R56400)
2
2.2 ASQC Standard:
2.1 ASTM Standards:
Cl Specifications of General Requirements for a Quality
E8 Test Methods for Tension Testing of Metallic Materials
3
Program
E10 Test Method for Brinell Hardness of Metallic Materials
2.3 ISO Standard:
E18 Test Methods for Rockwell Hardness of Metallic Ma-
4
ISO 9001 Quality Management Systems
terials
E29 Practice for Using Significant Digits in Test Data to
3. Terminology
Determine Conformance with Specifications
3.1 Definitions of Terms Specific to This Standard:
E92 Test Method for Vickers Hardness of Metallic Materi-
3.1.1 lot—the total number of forgings produced from the
als
same heat under the same conditions at essentially the same
E165 PracticeforLiquidPenetrantExaminationforGeneral
time.
Industry
E1409 Test Method for Determination of Oxygen and
4. Ordering Information
Nitrogen inTitanium andTitaniumAlloys by the Inert Gas
4.1 Inquiries and orders for forgings under this specification
Fusion Technique
shall include the following information:
E1447 Test Method for Determination of Hydrogen in
4.1.1 Quantity, number of pieces,
Titanium and Titanium Alloys by Inert Gas Fusion Ther-
4.1.2 ASTM designation and date of issue, material grade,
mal Conductivity/Infrared Detection Method
4.1.3 Condition,
E2371 Test Method for Analysis of Titanium and Titanium
4.1.4 Mechanical properties,
Alloys by Atomic Emission Plasma Spectrometry
4.1.5 Finish,
F67 Specification for Unalloyed Titanium, for Surgical
4.1.6 Applicable dimensions or drawing number,
Implant Applications (UNS R50250, UNS R50400, UNS
4.1.7 Special tests, if any, and
R50550, UNS R50700)
4.1.8 Other requirements.
F136 Specification for Wrought Titanium-6Aluminum-
5. Materials and Manufacture
5.1 Material for forgings shall be bars or wire fabricated in
1
This specification is under the jurisdiction of ASTM Committee F04 on
accordance with Specification F136, F1295,or F1472.
Medical and Surgical Materials and Devices and is the direct responsibility of
5.2 The material shall be forged by hammering, pressing,
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved May 1, 2006. Published May 2006. Originally extruding,orupsettingandshallbeprocessed,ifpracticable,so
approved in 1979. Last previous edition approved in 2000 as F620 – 00. DOI:
10.1520/F0620-06.
2 3
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.
4
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.
*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 – 06
as to cause metal flow during the hot-working operation in the 7.2.1 Perform at least one tension test from each lot in the
direction most favorable for resisting stresses encountered in longitudinal direction. Should this test result not meet the
service, as may be indicated to the fabricator by the purchaser. specifiedrequirements,testtwoadditionaltestpiecesrepresen-
5.3 Forgings shall be free of splits, scale, cracks, flaws, and tative of the same lot, in the same manner, for each failed test
other imperfections not consistent with good commercial piece. The lot shall be considered
...

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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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1.4 This test method applies to bearing components manufactured from UHMWPE.  
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SCOPE
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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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1.6 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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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.  
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1.5 The values stated in SI units are to be regarded as the standard.  
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SIGNIFICANCE AND USE
A1.1 Significance and Use
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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.  
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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off