ASTM F67-13

Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strips, sheets, plates, bars, billets, forgings, and wires used for the manufacture of surgical implants. The four grades identified here are defined as follows: Grade 1—UNS R50250; Grade 2—UNS R50400; Grade 3—UNS R50550; and Grade 4—UNS R50700. Mill products may be supplied with a descaled or pickled, abrasive blasted, chemically milled, ground, machined, peeled, or polished finish, or as specified by the purchaser. Materials shall be furnished in the hotworked, cold-worked, forged, annealed, or stress-relieved condition. Mechanical properties to which the titanium materials shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium strip, sheet, plate, bar, billet, forging, and wire used for the manufacture of surgical implants.  
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: 31-May-2013
• 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 F67-06 - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• Effective Date: 01-Jun-2013
• Replaced By: 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
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 01-Jun-2013
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Jun-2013
• Referred By: ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2384-10(2016) - Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
• Effective Date: 01-Jun-2013
• Referred By: ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
• Effective Date: 01-Jun-2013
• Referred By: ASTM F1580-18 - Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2066-23 - Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 01-Jun-2013
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Jun-2013
• Referred By: ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 01-Jun-2013

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:F67 −13
Standard Specification for
Unalloyed Titanium, for Surgical Implant Applications (UNS
1
R50250, UNS R50400, UNS R50550, UNS R50700)
ThisstandardisissuedunderthefixeddesignationF67;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E1941Test Method for Determination of Carbon in Refrac-
toryandReactiveMetalsandTheirAlloysbyCombustion
1.1 This specification covers the chemical, mechanical, and
Analysis
metallurgical requirements for four grades of unalloyed tita-
E2371Test Method for Analysis of Titanium and Titanium
nium strip, sheet, plate, bar, billet, forging, and wire used for
AlloysbyDirectCurrentPlasmaandInductivelyCoupled
the manufacture of surgical implants.
Plasma Atomic Emission Spectrometry (Performance-
1.2 The values stated in either SI units or inch-pound units
Based Test Methodology)
are to be regarded separately as standard. The values stated in
E2626Guide for Spectrometric Analysis of Reactive and
each system may not be exact equivalents; therefore, each
Refractory Metals
system shall be used independently of the other. Combining
F981Practice for Assessment of Compatibility of Biomate-
values from the two systems may result in non-conformance
rials for Surgical Implants with Respect to Effect of
with the standard.
Materials on Muscle and Bone
IEEE/ASTM SI 10American National Standard for Metric
2. Referenced Documents
Practice
2
2.1 ASTM Standards: 3
2.2 Aerospace Material Specification:
B265Specification for Titanium and Titanium Alloy Strip,
AMS 2249Chemical Check Analysis Limits, Titanium and
Sheet, and Plate
Titanium Alloys
B348Specification for Titanium and Titanium Alloy Bars
AMS 2380Approval and Control of Premium Quality Tita-
and Billets
nium Alloys
B381Specification for Titanium and Titanium Alloy Forg-
AMS 2631Ultrasonic Inspection TitaniumAlloy Bar, Billet
ings
and Plate
E8/E8MTest Methods for Tension Testing of Metallic Ma-
2.3 ISO Standards:
terials
ISO 5832-2Implants for Surgery—Metallic Materials—
E29Practice for Using Significant Digits in Test Data to
4
Unalloyed Titanium
Determine Conformance with Specifications
ISO 6892Metallic Materials—Tensile Testing at Ambient
E290Test Methods for Bend Testing of Material for Ductil-
4
Temperature
ity
4
ISO 9001Quality Management Systems
E1409TestMethodforDeterminationofOxygenandNitro-
gen in Titanium and Titanium Alloys by the Inert Gas
3. Terminology
Fusion Technique
E1447Test Method for Determination of Hydrogen in Tita- 3.1 Definitions of Terms Specific to This Standard:
nium and Titanium Alloys by Inert Gas Fusion Thermal
3.1.1 lot, n—the total number of mill products produced
Conductivity/Infrared Detection Method
from the same melt heat under the same conditions at essen-
tially the same time.
3.1.2 cold work, n—any mechanical deformation process
1
This specification is under the jurisdiction of ASTM Committee F04 on
performed below the recrystallization temperature which re-
Medical and Surgical Materials and Devices and is the direct responsibility of
sults in strain hardening of the material.
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved June 1, 2013. Published August 2013. Originally
approved in 1966. Last previous edition approved in 2006 as F67–06. DOI:
10.1520/F0067-13.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
the ASTM website. Milwaukee, WI 53203.
*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 ----------------------
F67−13
A
TABLE 2 Product Analysis Tolerances
3.1.3 hot work, n—any mechanical deformation process
Limit or Maximum of Tolerance Under the
performed above the recrystallization temperature.
Element Specified Range %, Minimum or Over the
B
3.1.4 alpha case, n—oxygen, nitrogen or carbon-enriched,
(mass/mass) Maximum Limit
alpha-stabilized surface which results from elevated tempera-
Nitrogen up to 0.05 0.02
Carbon 0.10 0.02
ture exposure.
Hydrogen up to 0.015 0.0020
Iron up to 0.25 0.10
4. Product Classification
Iron over 0.25 0.15
Oxygen up to 0.20 0.02
4.1 ProductclassificationsareconsistentwithSpecifications
Oxygen over 0.20 0.03
B265, B348, and B381.
A
Refer to
...

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: F67 − 06 F67 − 13
Standard Specification for
Unalloyed Titanium, for Surgical Implant Applications (UNS
1
R50250, UNS R50400, UNS R50550, UNS R50700)
This standard is issued under the fixed designation F67; 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 chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium
strip, sheet, plate, bar, billet, forging, and wire used for the manufacture of surgical implants.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as the standard. The SI equivalents in
parentheses are for information only.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
2.1 ASTM Standards:
B265 Specification for Titanium and Titanium Alloy Strip, Sheet, and Plate
B348 Specification for Titanium and Titanium Alloy Bars and Billets
B381 Specification for Titanium and Titanium Alloy Forgings
E8E8/E8M Test Methods for Tension Testing of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E290 Test Methods for Bend Testing of Material for Ductility
E1409 Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by the Inert Gas Fusion
Technique
E1447 Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal
Conductivity/Infrared Detection Method
E1941 Test Method for Determination of Carbon in Refractory and Reactive Metals and Their Alloys by Combustion Analysis
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)
E2626 Guide for Spectrometric Analysis of Reactive and Refractory Metals
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 Aerospace Material Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium Alloys
AMS 2380 Approval and Control of Premium Quality Titanium Alloys
AMS 2631 Ultrasonic Inspection Titanium Alloy Bar, Billet and Plate
2.3 ISO Standards:
4
ISO 5832-2 Implants for Surgery—Metallic Materials—Unalloyed Titanium
4
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
4
ISO 9001 Quality Management Systems
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved June 1, 2006June 1, 2013. Published June 2006 August 2013. Originally approved in 1966. Last previous edition approved in 20002006 as
F67 – 00.F67 – 06. DOI: 10.1520/F0067-06.10.1520/F0067-13.
2
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.
3
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001.
4
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203.
*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 ----------------------
F67 − 13
2.4 American Society for Quality (ASQ) Standard:
4
C1 Specifications of General Requirements for a Quality Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot, n—the total number of mill products produced from the same melt heat under the same conditions at essentially the
same time.
3.1.2 cold work, n—any mechanical deformation process performed below the recrystallization temperature which results in
strain hardening of the material.
3.1.3 hot work, n—any mechanical deformation process performed above the recrys
...