ASTM F620-20

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 SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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 nonconformance with the standard.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

General Information

• Status: Published
• Publication Date: 31-Jan-2020
• 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(2015) - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
• Effective Date: 01-Feb-2020
• Refers: ASTM F1295-24 - Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
• Effective Date: 15-Mar-2024
• Refers: ASTM E8/E8M-24 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jan-2024
• Refers: ASTM E539-19 - Standard Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
• Effective Date: 01-Mar-2019
• Refers: ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2018
• Refers: ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2017
• Refers: ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• Effective Date: 01-Mar-2017
• Refers: ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 15-Jul-2016
• Refers: ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Feb-2015
• Refers: ASTM E10-14 - Standard Test Method for Brinell Hardness of Metallic Materials
• Effective Date: 01-May-2014
• Refers: ASTM F601-13 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• Effective Date: 01-Dec-2013
• Refers: ASTM F2066-13e1 - Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
• Effective Date: 01-Oct-2013
• Refers: ASTM E8/E8M-13 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Jun-2013
• Refers: ASTM F67-13 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• Effective Date: 01-Jun-2013
• Refers: ASTM E18-12 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Dec-2012

Overview

ASTM F620-20: Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition sets the requirements for titanium alloy forgings used in surgical implants, especially orthopaedic medical devices. This specification applies to forgings using specific alpha plus beta titanium alloys, providing critical guidance for manufacturers and purchasers in ensuring material reliability, safety, and biocompatibility for medical implant applications.

ASTM F620-20 details acceptable forging methods, mandatory and optional product tests, surface and mechanical requirements, and certifications necessary for high-performance implant materials. Adhering to this standard is essential for maintaining product quality and meeting the stringent demands of the medical device industry.

Key Topics

• Applicable Titanium Alloys: Covers alpha plus beta titanium alloys, including those specified in ASTM F136, F1295, F1472, and F2066, each identified by its respective UNS designation.
• Forging Processes: Material must be hot forged by hammering, pressing, extruding, or upsetting, ensuring the optimal alignment of the metal’s structure to withstand operational stresses.
• Processing & Annealing: After hot working, forgings are subjected to an annealing heat treatment, followed by controlled cooling to optimize microstructure and mechanical properties.
• Mechanical and Chemical Properties: Forgings must be free from defects and meet specified requirements for chemical composition, tensile strength, hardness, elongation, and area reduction.
• Microstructure: The standard emphasizes a fine, homogenous alpha plus beta phase dispersion, avoiding continuous alpha networks and coarse alpha platelets, ensuring superior fatigue resistance and performance.
• Testing and Inspection: Mandates methods for mechanical testing, hardness testing, chemical analysis, and non-destructive testing to verify product integrity.
• Certification and Traceability: Suppliers must provide certification of compliance and maintain thorough quality records as per ISO 9001 or equivalent.

Applications

• Orthopaedic Implants: Titanium alloy forgings compliant with ASTM F620-20 are commonly used in the manufacture of orthopaedic devices such as joint replacements, bone plates, and screws, where a balance of strength, ductility, and corrosion resistance is vital.
• Dental Implants: High biocompatibility and mechanical strength make these alloys suitable for dental surgical applications.
• Other Surgical Devices: The standard supports applications in specialized surgical implants where fatigue resistance and bio-inertness are essential.

By meeting ASTM F620-20 requirements, manufacturers can ensure that implants will perform reliably in the demanding environment of the human body, minimizing risks of rejection or failure.

Related Standards

• ASTM F136 - Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implants
• ASTM F1295 - Specification for Titanium-6Aluminum-7Niobium Alloy for Surgical Implants
• ASTM F1472 - Specification for Titanium-6Aluminum-4Vanadium Alloy for Surgical Implants
• ASTM F2066 - Specification for Titanium-15 Molybdenum Alloy for Surgical Implants
• ASTM F67 - Specification for Unalloyed Titanium for Surgical Implants
• ASTM E8/E8M - Test Methods for Tension Testing of Metallic Materials
• ASTM E10/E18/E92 - Hardness Test Methods for Metallic Materials
• ISO 9001 - Quality Management Systems
• IEEE/ASTM SI 10 - Standard for SI Units

Summary

ASTM F620-20 is a critical quality, safety, and performance benchmark for titanium alloy forgings used in surgical implants. Complying with this standard ensures product consistency, mechanical reliability, and biocompatibility, supporting manufacturers, regulatory compliance, and patient safety worldwide. This standard is referenced across the global medical device supply chain to guarantee the highest standards for orthopaedic and surgical implant components.

Standards Content (Sample)

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.
Designation: F620 −20
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* E18 Test Methods for Rockwell Hardness of Metallic Ma-
terials
1.1 This specification covers the requirements for titanium
E29 Practice for Using Significant Digits in Test Data to
alloy forgings for surgical implants, in the alpha plus beta
Determine Conformance with Specifications
condition, when the material forged conforms to Specifications
E92 Test Methods for Vickers Hardness and Knoop Hard-
F136 (UNS R56401), F1295 (UNS R56700), F1472 (UNS
ness of Metallic Materials
R56400), or F2066 (UNS R58150).
E165 Practice for Liquid Penetrant Testing for General
1.2 The SI units in this standard are the primary units. The
Industry
values stated in either primary SI units or secondary inch-
E539 Test Method for Analysis of Titanium Alloys by
pound units are to be regarded separately as standard. The
WavelengthDispersiveX-RayFluorescenceSpectrometry
values stated in each system may not be exact equivalents;
E1409 Test Method for Determination of Oxygen and Nitro-
therefore,eachsystemshallbeusedindependentlyoftheother.
gen in Titanium and TitaniumAlloys by Inert Gas Fusion
Combining values from the two systems may result in noncon-
E1447 Test Method for Determination of Hydrogen in Tita-
formance with the standard.
nium and Titanium Alloys by Inert Gas Fusion Thermal
1.3 This standard does not purport to address all of the
Conductivity/Infrared Detection Method
safety concerns, if any, associated with its use. It is the
E2371 Test Method for Analysis of Titanium and Titanium
responsibility of the user of this standard to establish appro-
Alloys by Direct Current Plasma and Inductively Coupled
priate safety, health, and environmental practices and deter-
Plasma Atomic Emission Spectrometry (Performance-
mine the applicability of regulatory limitations prior to use.
Based Test Methodology)
1.4 This international standard was developed in accor-
E2994 Test Method for Analysis of Titanium and Titanium
dance with internationally recognized principles on standard-
AlloysbySparkAtomicEmissionSpectrometryandGlow
ization established in the Decision on Principles for the
Discharge Atomic Emission Spectrometry (Performance-
Development of International Standards, Guides and Recom-
Based Method)
mendations issued by the World Trade Organization Technical
F67 Specification for Unalloyed Titanium, for Surgical Im-
Barriers to Trade (TBT) Committee.
plant Applications (UNS R50250, UNS R50400, UNS
2. Referenced Documents
R50550, UNS R50700)
F136 Specification for Wrought Titanium-6Aluminum-
2.1 ASTM Standards:
E8/E8M Test Methods for Tension Testing of Metallic Ma- 4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
terials Implant Applications (UNS R56401)
E10 Test Method for Brinell Hardness of Metallic Materials
F601 Practice for Fluorescent Penetrant Inspection of Me-
tallic Surgical Implants
F1295 Specification for Wrought Titanium-6Aluminum-
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
7Niobium Alloy for Surgical Implant Applications (UNS
Subcommittee F04.12 on Metallurgical Materials.
R56700)
Current edition approved Feb. 1, 2020. Published March 2020. Originally
F1472 Specification for Wrought Titanium-6Aluminum-
approvedin1979.Lastpreviouseditionapprovedin2015asF620 – 11(2015).DOI:
10.1520/F0620-20. 4VanadiumAlloy for Surgical ImplantApplications (UNS
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
R56400)
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F2066 Specification for Wrought Titanium-15 Molybdenum
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Alloy for Surgical Implant Applications (UNS R58150)
*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 − 20
IEEE/ASTM SI 10 American National Standard for the Use be determined and confirmed by the forger, and shall meet the
of the International System of Units (SI): The Modern product check analysis limits of the appropriate material
Metric System specification.
6.1.1 Hydrogen content shall be determined on annealed
2.2 ISO Standard:
forgings. Samples for hydrogen analysis shall be taken after
ISO 9001 Quality management systems requirement
descaling, pickling, or chemical milling, if these operations are
performed.
3. Terminology
6.2 For referee purposes, Test Methods E539, E1409,
3.1 Definitions of Terms Specific to This Standard:
E1447, E2371 and E2994 shall be used.
3.1.1 lot—the total number of forgings produced from the
same heat under the same conditions and heat treated at
7. Mechanical Requirements
essentially the same time.
7.1 The mechanical properties of forgings shall be tested by
the forger and shall comply with the minimum mechanical
4. Ordering Information
properties as specified in Specifications F136, F1295, F1472,
4.1 Inquiries and orders for forgings under this specification
or F2066.
shall include the following information:
7.1.1 Test specimens shall be taken from a representative
4.1.1 Quantity, number of pieces;
forging if possible, or from a representative forged test bar. A
4.1.2 ASTM designation and date of issue, material grade;
representative test bar may only be used if the configuration is
4.1.3 Condition;
such that a test bar cannot be obtained. Any specially forged
4.1.4 Mechanical properties;
test bar must be annealed with the forgings it represents.
4.1.5 Finish;
7.1.2 Specimens for tension tests shall be machined and
4.1.6 Applicable dimensions or drawing number;
tested in accordance with Test Methods E8/E8M. Tensile
4.1.7 Special tests, if any; and
properties shall be determined using a strain rate of 0.003 to
4.1.8 Other requirements.
0.007 mm/mm/min [in./in./min] through yield and then the
crosshead speed may be increased so as to produce fracture in
5. Materials and Manufacture
approximately one additional minute.
5.1 Material for forgings shall be bars or wire fabricated in
7.2 Number of Tests:
accordance with Specification F136, F1295, F1472,or F2066.
7.2.1 Perform at least one tension test from each lot in the
5.2 The material shall be forged by hammering, pressing,
longitudinal direction. Should any test specimen not meet the
extruding,orupsettingandshallbeprocessed,ifpracticable,so
specified requirements, test two additional test pieces represen-
as to cause metal flow during the hot-working operation in the
tative of the same lot, in the same manner, for each failed test
direction most favorable for resisting stresses encountered in
specimen. The lot will be considered in compliance only if all
service, as may be indicated to the fabricator by the purchaser.
additional test pieces meet the specified requirements.
7.2.2 Tensile tests results for which any specimen fractures
5.3 Forgings shall be free of splits, scale, cracks,
...

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 (Reapproved 2015) F620 − 20
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 SI units in this standard are the primary units. The values stated in either primary SI units or secondary 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-conformancenonconformance
with the standard.
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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 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.
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 Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E165 Practice for Liquid Penetrant Testing for General Industry
E539 Test Method for Analysis of Titanium Alloys by Wavelength Dispersive X-Ray Fluorescence Spectrometry
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)
E2994 Test Method for Analysis of Titanium and Titanium Alloys by Spark Atomic Emission Spectrometry and Glow Discharge
Atomic Emission Spectrometry (Performance-Based Method)
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
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, 2015Feb. 1, 2020. Published December 2015March 2020. Originally approved in 1979. Last previous edition approved in 20112015 as
F620 – 11.F620 – 11(2015). DOI: 10.1520/F0620-11R15.10.1520/F0620-20.
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.
*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 − 20
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)
IEEE/ASTM 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 Systemsmanagement systems requirement
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
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,pieces;
4.1.2 ASTM designation and date of issue, material grade,grade;
4.1.3 Condition,Condition;
4.1.4 Mechanical properties,properties;
4.1.5 Finish,Finish;
4.1.6 Applicable dimensions or drawing number,number;
4.1.7 Special tests, if any,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 Practice 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,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 check 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 E539, E1409, E1447, and E2371 and E2994 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 represe
...