ASTM F620-11(2015)

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 values stated in either SI units or 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-conformance with the standard.

General Information

• Status: Historical
• Publication Date: 30-Nov-2015
• 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

Relations

• Replaces: ASTM F620-11 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Dec-2015
• Replaced By: ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Feb-2020
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Dec-2015
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 01-Dec-2015
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Dec-2015

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 −11 (Reapproved 2015)
Standard Specification for
Titanium Alloy Forgings for Surgical Implants in the Alpha
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* E2371 Test Method for Analysis of Titanium and Titanium
Alloys by Direct Current Plasma and Inductively Coupled
1.1 This specification covers the requirements for titanium
Plasma Atomic Emission Spectrometry (Performance-
alloy forgings for surgical implants, in the alpha plus beta
Based Test Methodology)
condition, when the material forged conforms to Specifications
F67 Specification for Unalloyed Titanium, for Surgical Im-
F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS
plant Applications (UNS R50250, UNS R50400, UNS
R56400), or F2066 (UNS R58150).
R50550, UNS R50700)
1.2 The values stated in either SI units or inch-pound units
F136 Specification for Wrought Titanium-6Aluminum-
are to be regarded separately as standard. The values stated in
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
each system may not be exact equivalents; therefore, each
Implant Applications (UNS R56401)
system shall be used independently of the other. Combining
F601 Practice for Fluorescent Penetrant Inspection of Me-
values from the two systems may result in non-conformance
tallic Surgical Implants
with the standard.
F1295 Specification for Wrought Titanium-6Aluminum-
7Niobium Alloy for Surgical Implant Applications (UNS
2. Referenced Documents
R56700)
2.1 ASTM Standards:
F1472 Specification for Wrought Titanium-6Aluminum-
E8/E8M Test Methods for Tension Testing of Metallic Ma-
4VanadiumAlloy for Surgical ImplantApplications (UNS
terials
R56400)
E10 Test Method for Brinell Hardness of Metallic Materials
F2066 Specification for Wrought Titanium-15 Molybdenum
E18 Test Methods for Rockwell Hardness of Metallic Ma-
Alloy for Surgical Implant Applications (UNS R58150)
terials
SI 10 American National Standard for the Use of the
E29 Practice for Using Significant Digits in Test Data to
International System of Units (SI): The Modern Metric
Determine Conformance with Specifications
System
E92 Test Method forVickers Hardness of Metallic Materials
2.2 ISO Standard:
(Withdrawn 2010)
ISO 9001 Quality Management Systems
E165 Practice for Liquid Penetrant Examination for General
Industry
3. Terminology
E1409 Test Method for Determination of Oxygen and Nitro-
3.1 Definitions of Terms Specific to This Standard:
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
3.1.1 lot—the total number of forgings produced from the
E1447 Test Method for Determination of Hydrogen in Tita-
same heat under the same conditions and heat treated at
nium and Titanium Alloys by Inert Gas Fusion Thermal
essentially the same time.
Conductivity/Infrared Detection Method
4. Ordering Information
This specification is under the jurisdiction of ASTM Committee F04 on
4.1 Inquiries and orders for forgings under this specification
Medical and Surgical Materials and Devicesand is the direct responsibility of
shall include the following information:
Subcommittee F04.12 on Metallurgical Materials.
4.1.1 Quantity, number of pieces,
Current edition approved Dec. 1, 2015. Published December 2015. Originally
approved in 1979. Last previous edition approved in 2011 as F620 – 11. DOI: 4.1.2 ASTM designation and date of issue, material grade,
10.1520/F0620-11R15.
4.1.3 Condition,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1.4 Mechanical properties,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
The last approved version of this historical standard is referenced on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.astm.org. 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
F620−11 (2015)
4.1.5 Finish, 0.007 mm/mm/min [in./in./min] through yield and then the
4.1.6 Applicable dimensions or drawing number, crosshead speed may be increased so as to produce fracture in
4.1.7 Special tests, if any, and approximately one additional minute.
4.1.8 Other requirements.
7.2 Number of Tests:
7.2.1 Perform at least one tension test from each lot in the
5. Materials and Manufacture
longitudinal direction. Should any test specimen not meet the
5.1 Material for forgings shall be bars or wire fabricated in specified requirements, test two additional test pieces represen-
accordance with Specification F136, F1295, F1472,or F2066.
tative of the same lot, in the same manner, for each failed test
specimen. The lot will be considered in compliance only if all
5.2 The material shall be forged by hammering, pressing,
additional test pieces meet the specified requirements.
extruding,orupsettingandshallbeprocessed,ifpracticable,so
7.2.2 Tensile tests results for which any specimen fractures
as to cause metal flow during the hot-working operation in the
outside the gauge length shall be considered valid, if both the
direction most favorable for resisting stresses encountered in
elongation and reduction of area meet the minimum require-
service, as may be indicated to the fabricator by the purchaser.
ments specified. If either the elongation or reduction of area is
5.3 Forgings shall be free of splits, scale, cracks, flaws, and
less than the minimum requirement, invalidate the specimen
other imperfections not consistent with good commercial
and retest. Retest one specimen for each invalidated specimen.
practice(seeNote1).Offsetormismatchallowance,dependent
7.2.3 Ifeithertheelongationorreductionofareaislessthan
upon part size and configuration, shall be within standard
the minimum requirement, discard the test and retest. Retest
forging tolerances.
one specimen for each specimen that did not meet the
minimum requirements.
NOTE 1—Compliance to these requirements may be verified by Test
Method E165 or Practice F601 or other suitable methods.
7.3 When desired, hardness may be specified on the pur-
5.4 After all hot-working operations have been completed,
chase order or drawing and shall be determined in accordance
the forgings shall receive an annealing treatment consisting of
with Test Methods E10, E18,or E92.
heating the parts to an appropriate elevated temperature for a
8. Microstructure
specified dwell time followed by appropriate cooling to meet
the applicable metallurgical requirements specified herein.
8.1 Themicrostructureshallbeafinedispersionofthealpha
andbetaphasesresultingfromprocessinginthealphaplusbeta
5.5 Optionalidentificationmarks,includingthemanufactur-
phasefield.Thereshallbenocontinuousalph
...

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 F620 − 11 (Reapproved 2015)
Standard Specification for
Titanium Alloy Forgings for Surgical Implants in the Alpha
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 values stated in either SI units or 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-conformance with the standard.
2. Referenced Documents
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 Method for Vickers Hardness of Metallic Materials (Withdrawn 2010)
E165 Practice for Liquid Penetrant Examination for General Industry
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)
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
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 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
SI 10 American National Standard for the Use of the International System of Units (SI): The Modern Metric System
2.2 ISO Standard:
ISO 9001 Quality Management Systems
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
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, 2011Dec. 1, 2015. Published December 2011 December 2015. Originally approved in 1979. Last previous edition approved in 20062011
as F620 – 06.F620 – 11. DOI: 10.1520/F0620-11.10.1520/F0620-11R15.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
The last approved version of this historical standard is referenced on www.astm.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 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
F620 − 11 (2015)
3.1.1 lot—the total number of forgings produced from the same heat under the same conditions and heat treated at essentially
the same time.
4. Ordering Information
4.1 Inquiries and orders for forgings under this specification shall include the following information:
4.1.1 Quantity, number of pieces,
4.1.2 ASTM designation and date of issue, material grade,
4.1.3 Condition,
4.1.4 Mechanical properties,
4.1.5 Finish,
4.1.6 Applicable dimensions or drawing number,
4.1.7 Special tests, if any, and
4.1.8 Other requirements.
5. Materials and Manufacture
5.1 Material for forgings shall be bars or wire fabricated in accordance with Specification F136, F1295, F1472, or F2066.
5.2 The material shall be forged by hammering, pressing, extruding, or upsetting and shall be processed, if practicable, so as
to cause metal flow during the hot-working operation in the direction most favorable for resisting stresses encountered in service,
as may be indicated to the fabricator by the purchaser.
5.3 Forgings shall be free of splits, scale, cracks, flaws, and other imperfections not consistent with good commercial practice
(see Note 1). Offset or mismatch allowance, dependent upon part size and configuration, shall be within standard forging
tolerances.
NOTE 1—Compliance to these requirements may be verified by Test Method E165 or Practice F601 or other suitable methods.
5.4 After all hot-working operations have been completed, the forgings shall receive an annealing treatment consisting of
heating the parts to an appropriate elevated temperature for a specified dwell time followed by appropriate cooling to meet the
applicable metallurgical requirements specified herein.
5.5 Optional identification marks, including the manufacturer’s logo, material designation, heat code number, and impression
number, may be placed upon each forging, the method and location of which shall be specified by the purchaser.
6. Chemical Composition
6.1 When specified by the purchaser, the chemical composition of either the forging bars or the completed forgings shall be
determined and confirmed by the forger, and shall meet the product analysis limits of the appropriate material specification.
6.1.1 Hydrogen content shall be determined on annealed forgings. Samples for hydrogen analysis shall be taken after descaling,
pickling, or chemical milling, if these operations are performed.
6.2 For referee purposes, Test Methods E1409, E1447, and E2371 shall be used.
7. Mechanical Requirements
7.1 The mechanical properties of forgings shall be tested by the forger and shall comply with the minimum mechanical
properties as specified in Specifications F136, F1295, F1472, or F2066.
7.1.1 Test specimens shall be taken from a representative forging if possible, or from a representative forged test bar. A
representative test bar may only be used if the configuration is such that a test bar cannot be obtained. Any specially forged test
bar must be annealed with the forgings it represents.
7.1.2 Specimens for tension tests shal
...