ASTM F67-00
(Specification)Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium used for the manufacture of surgical implants.
1.2 The values stated in inch-pound units are to be regarded as the standard.
General Information
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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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 67 – 00
Standard Specification for
Unalloyed Titanium, for Surgical Implant Applications (UNS
,
1 2
R50250, UNS R50400, UNS R50550, UNS R50700)
ThisstandardisissuedunderthefixeddesignationF 67;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 Aerospace Material Specification:
AMS 2249 Chemical Check Analysis Limits, Titanium and
1.1 This specification covers the chemical, mechanical, and
Titanium Alloys
metallurgical requirements for four grades of unalloyed tita-
2.3 American Society for Quality (ASQ) Standard:
nium used for the manufacture of surgical implants.
C1 Specifications of General Requirements for a Quality
1.2 The values stated in inch-pound units are to be regarded
Program
as the standard.
2.4 Society of Automotive Engineers Standard:
2. Referenced Documents SAE J1086 Practice for Numbering Metals and Alloys
(UNS)
2.1 ASTM Standards:
B 265 Specification for Titanium and Titanium Alloy Strip,
3. Product Classification
Sheet, and Plate
3.1 Product classifications are consistent with Standard
B 348 Specification for Titanium and Titanium Alloy Bars
Specifications B 265, B 348 and B 381.
and Billets
3.1.1 Strip—Anyproduct0.1875in.(4.75mm)andunderin
B 381 Specification for Titanium and Titanium Alloy Forg-
thickness and less than 24 in. (610 mm) in width.
ings
3.1.2 Sheet—Any product 0.1875 in. (4.75 mm) and under
E 8 Test Methods forTensionTesting of Metallic Materials
in thickness and 24 in. (610 mm) or more in width.
E 120 Test Methods for ChemicalAnalysis of Titanium and
3.1.3 Plate—Anyproduct0.1875in.(4.75mm)inthickness
Titanium Alloys
and over 10 in. (254 mm) in width.
E 290 Test Method for Semi-Guided Bend Test for Ductil-
3.1.4 Bar—A hot rolled, forged, or cold worked semi-
ity of Metallic Materials
finished solid section product whose cross sectional area is
E 527 Practice for Numbering Metals and Alloys
2 2
equal to or less than 16 in. (10322 mm ); rectangular bar must
E 1409 Test Method for Determination of Oxygen in Tita-
be less than or equal to 10 in. (254 mm) in width and greater
nium Alloys by the Inert Gas Fusion Technique
than 0.1875 in. (4.75 mm) in thickness.
E 1447 Test Method for Determination of Hydrogen in
3.1.5 Billet—A solid semi-finished section hot rolled or
Titanium and Titanium Alloys by the Inert Gas Fusion
7 forgedfromaningot,withacrosssectionalareagreaterthan16
Thermal Conductivity Method
2 2
in (10322 mm ) whose width is less than 5 times its thickness.
F 981 Practice for Assessment of Compatibility of Bioma-
3.1.6 Forging—Any product of work on metal formed to a
terials for Surgical Implants with Respect to Effect of
desired shape by impact or pressure in hammers, forging
Materials on Muscle and Bone
machines, upset presses or related forming equipment.
F 1341 Specification for Unalloyed Titanium Wire for Sur-
3.1.7 Wire—Coiled round and non-round product with a
gical Implant Applications
diameterormajordimensionequaltoorgreaterthan0.3130in.
NOTE 1—Wire less than or equal to 0.3125 in. in diameter or major
This specification is under the jurisdiction of ASTM Committee F04 on
dimension is covered in ASTM F 1341.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
3.1.8 Other—Other forms and shapes, including tubing,
Current edition approved May 10, 2000. Published August 2000. Originally
may be provided by agreement between purchaser and sup-
published as F 67 – 66. Last previous edition F 67 – 95.
2 plier.
New UNS designation established in accordance with E 527 and SAE J1086.
Annual Book of ASTM Standards, Vol 02.04.
Annual Book of ASTM Standards, Vol 03.01.
5 9
Annual Book of ASTM Standards, Vol 03.05. Available from Society of Automotive Engineers, 400 Commonwealth Drive,
Annual Book of ASTM Standards, Vol 1.01. Warrendale, PA 15096.
7 10
Annual Book of ASTM Standards, Vol 3.06. Available fromAmerican Society for Quality Control, 161W.WisconsinAve.,
Annual Book of ASTM Standards, Vol 13.01. Milwaukee, WI 53203.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F67–00
TABLE 1 Chemical Requirements
A
Composition , % (mass/mass)
Element
Grade 1 Grade 2 Grade 3 Grade 4
UNS R50250 UNS R50400 UNS R50550 UNS R50700
Nitrogen, max 0.03 0.03 0.05 0.05
Carbon, max 0.08 0.08 0.08 0.08
B
Hydrogen, max 0.015 0.015 0.015 0.015
Iron, max 0.20 0.30 0.30 0.50
Oxygen, max 0.18 0.25 0.35 0.40
Titanium balance balance balance balance
A
Forgings are designated Grade F-1, F-2, F-3, or F-4 respectively. Forging compositions are as specified in Table 1.
B
Maximum hydrogen content for billet is 0.0100 wt%.
4. Ordering Information 6.2.1 Acceptance or rejection of a heat or lot of material
may be made by the purchaser on the basis of this product
4.1 Inquiries and orders for material under this specification
analysis.
shall include the following information:
6.2.2 Product analysis tolerances do not broaden the speci-
4.1.1 Quantity (weight or number of pieces),
fied heat analysis requirements but cover variations between
4.1.2 Grade (1, 2, 3, or 4),
laboratories in the measurement of chemical content. Product
4.1.3 ASTM designation,
analysis limits shall be as specified in Table 2
4.1.4 Form (sheet, strip, plate, bar, billet, forging, wire or
6.3 For referee purposes, Test Methods E 120, E 1409 and
other forms),
E 1447 shall apply.
4.1.5 Condition (5.1),
6.3.1 Samples for chemical analysis shall be representative
4.1.6 Mechanical properties (if applicable, for special con-
of the material being tested.
ditions),
4.1.7 Finish (5.2),
NOTE 2—Precaution: Extremecaremustbetakeninsamplingtitanium
4.1.8 Applicable dimensions and tolerances including size,
for chemical analysis because of its affinity for elements such as oxygen,
nitrogen, and hydrogen. Therefore, when cutting samples for analysis, the
thickness, width, and length (exact, random, multiples) or
operation should be carried out in a dust-free atmosphere, if possible.
drawing number,
Chips should be collected from clean metal. Cutting tools should be clean
4.1.9 Special tests, and
and sharp. Samples for analysis should be stored in suitable containers.
4.1.10 Special requirements.
7. Mechanical Requirements
5. Manufacture
7.1 Bar, billet, and forging shall conform to the mechanical
5.1 Condition—Material shall be furnished in the hot-
property requirements prescribed in Table 3. Sheet, strip, and
rolled, cold-worked, forged, annealed or stress relieved condi-
plate shall conform to the mechanical property requirements
tion.
prescribed in Table 4. Grades may be ordered in the cold-
5.2 Finish—Unalloyed titanium material shall be free of
worked condition to higher minimum tensile strength but a
injurious external and internal imperfections of a nature that
minimum10 %elongationin4Dor2in.(50mm)mustbemet.
will interfere with the purpose for which it is intended.
7.2 For sheet and strip, the bend test specimen shall with-
Material may be furnished as descaled, as pickled, as sand-
standbeingbentcoldthroughanangleof105°withoutfracture
blasted, or as ground, or combinations of these operations. The
in the outside of the bent portion. The bend shall be made on
manufacturer shall be permitted to remove minor surface
a diameter equal to that shown in Table 4 for the applicable
imperfectionsbyspotgrindingifsuchgrindingdoesnotreduce
grade.
the d
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