Licença de uso exclusivo para Sistema de Implante Nacional Ltda.

Designation: F 67 – 00

Standard Specification for

Unalloyed Titanium, for Surgical Implant Applications (UNS
R50250, UNS R50400, UNS R50550, UNS R50700)1,2
This standard is issued under the fixed designation F 67; 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 (e) indicates an editorial change since the last revision or reapproval.

1. Scope 2.2 Aerospace Material Specification:

1.1 This specification covers the chemical, mechanical, and AMS 2249 Chemical Check Analysis Limits, Titanium and
metallurgical requirements for four grades of unalloyed tita- Titanium Alloys9
nium used for the manufacture of surgical implants. 2.3 American Society for Quality (ASQ) Standard:
1.2 The values stated in inch-pound units are to be regarded C1 Specifications of General Requirements for a Quality
as the standard. Program10
2.4 Society of Automotive Engineers Standard:
2. Referenced Documents SAE J1086 Practice for Numbering Metals and Alloys
2.1 ASTM Standards: (UNS)9
B 265 Specification for Titanium and Titanium Alloy Strip,
3. Product Classification
Sheet, and Plate3
B 348 Specification for Titanium and Titanium Alloy Bars 3.1 Product classifications are consistent with Standard
and Billets3 Specifications B 265, B 348 and B 381.
B 381 Specification for Titanium and Titanium Alloy Forg- 3.1.1 Strip—Any product 0.1875 in. (4.75 mm) and under in
ings3 thickness and less than 24 in. (610 mm) in width.
E 8 Test Methods for Tension Testing of Metallic Materials4 3.1.2 Sheet—Any product 0.1875 in. (4.75 mm) and under
E 120 Test Methods for Chemical Analysis of Titanium and in thickness and 24 in. (610 mm) or more in width.
Titanium Alloys5 3.1.3 Plate—Any product 0.1875 in. (4.75 mm) in thickness
E 290 Test Method for Semi-Guided Bend Test for Ductil- and over 10 in. (254 mm) in width.
ity of Metallic Materials4 3.1.4 Bar—A hot rolled, forged, or cold worked semi-
E 527 Practice for Numbering Metals and Alloys6 finished solid section product whose cross sectional area is
E 1409 Test Method for Determination of Oxygen in Tita- equal to or less than 16 in.2(10322 mm2); rectangular bar must
nium Alloys by the Inert Gas Fusion Technique7 be less than or equal to 10 in. (254 mm) in width and greater
E 1447 Test Method for Determination of Hydrogen in than 0.1875 in. (4.75 mm) in thickness.
Titanium and Titanium Alloys by the Inert Gas Fusion 3.1.5 Billet—A solid semi-finished section hot rolled or
Thermal Conductivity Method7 forged from an ingot, with a cross sectional area greater than 16
F 981 Practice for Assessment of Compatibility of Bioma- in2(10322 mm2) whose width is less than 5 times its thickness.
terials for Surgical Implants with Respect to Effect of 3.1.6 Forging—Any product of work on metal formed to a
Materials on Muscle and Bone8 desired shape by impact or pressure in hammers, forging
F 1341 Specification for Unalloyed Titanium Wire for Sur- machines, upset presses or related forming equipment.
gical Implant Applications8 3.1.7 Wire—Coiled round and non-round product with a
diameter or major dimension equal to or greater than 0.3130 in.
1
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
New UNS designation established in accordance with E 527 and SAE J1086. plier.
3
Annual Book of ASTM Standards, Vol 02.04.
4
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,
6
Annual Book of ASTM Standards, Vol 1.01. Warrendale, PA 15096.
7 10
Annual Book of ASTM Standards, Vol 3.06. Available from American Society for Quality Control, 161 W. Wisconsin Ave.,
8
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.

1
 Licença de uso exclusivo para Sistema de Implante Nacional Ltda.

F 67 – 00
TABLE 1 Chemical Requirements
CompositionA, % (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
Hydrogen, maxB 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

4.1 Inquiries and orders for material under this specification may be made by the purchaser on the basis of this product
shall include the following information: analysis.
4.1.1 Quantity (weight or number of pieces), 6.2.2 Product analysis tolerances do not broaden the speci-
4.1.2 Grade (1, 2, 3, or 4), fied heat analysis requirements but cover variations between
4.1.3 ASTM designation, laboratories in the measurement of chemical content. Product
4.1.4 Form (sheet, strip, plate, bar, billet, forging, wire or analysis limits shall be as specified in Table 2
other forms), 6.3 For referee purposes, Test Methods E 120, E 1409 and
4.1.5 Condition (5.1), E 1447 shall apply.
4.1.6 Mechanical properties (if applicable, for special con- 6.3.1 Samples for chemical analysis shall be representative
ditions), of the material being tested.
4.1.7 Finish (5.2), NOTE 2—Precaution: Extreme care must be taken in sampling titanium
4.1.8 Applicable dimensions and tolerances including size, for chemical analysis because of its affinity for elements such as oxygen,
thickness, width, and length (exact, random, multiples) or nitrogen, and hydrogen. Therefore, when cutting samples for analysis, the
drawing number, operation should be carried out in a dust-free atmosphere, if possible.
4.1.9 Special tests, and Chips should be collected from clean metal. Cutting tools should be clean
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 minimum 10 % elongation in 4D or 2 in. (50 mm) must be met.
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- stand being bent cold through an angle of 105° without fracture
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
imperfections by spot grinding if such grinding does not reduce grade.
the dimension below the minimum permitted by the dimen- 7.2.1 Supplementary bend test requirements for sheet and
sional tolerance ordered. plate are listed in S1.
7.3 Tension testing shall be performed in accordance with
6. Chemical Composition Test Methods E 8. Tensile properties shall be determined using
6.1 The heat analysis shall conform to the requirements as
to chemical composition prescribed in Table 1. Ingot analysis TABLE 2 Product Analysis TolerancesA
may be used for reporting all chemical requirements except Limit or Maximum of Tolerance Under the
hydrogen, samples of which shall be taken from the finished Element Specified Range %, Minimum or Over the
product. Supplier shall not ship material that is outside the (mass/mass) Maximum LimitB
limits specified in Table 1 for the applicable grade. Nitrogen up to 0.05 0.02
Carbon 0.10 0.02
6.1.1 Requirements for the major and minor elemental
Hydrogen up to 0.015 0.0020
constituents are listed in Table 1. Also listed are important Iron up to 0.25 0.10
residual elements. Analysis for elements not listed in Table 1 is Iron over 0.25 0.15
Oxygen up to 0.20 0.02
not required to verify compliance with this specification. Oxygen over 0.20 0.03
6.2 Product Analysis—The product analysis is either for the A
Refer to AMS 2249.
purpose of verifying the composition of a heat or lot or to B
Under minimum limit not applicable for elements where only a maximum
determine variations in the composition within the heat. percentage is indicated.

2
 Licença de uso exclusivo para Sistema de Implante Nacional Ltda.

F 67 – 00
TABLE 3 Mechanical Requirements: Annealed-Bar, Billet, 8. Certification
Forging, Wire and Other FormsA
8.1 The manufacturer’s certification that the material was
Yield Strength,
Tensile Strength,
0.2 % Offset, Elongation Reduction manufactured and tested in accordance with this specification
min
Grade min in 4D, min, of Area, together with a report of the test results shall be furnished to the
% min, %B
ksi MPa ksi MPa purchaser at the time of shipment.
1 35 240 25 170 24 30
2 50 345 40 275 20 30
9. Quality Program Requirements
3 65 450 55 380 18 30 9.1 The producer shall maintain a quality program, such as,
4 80 550 70 483 15 25
for example, is defined in ASQ C1.
A
These properties apply to forgings having a maximum cross section area not 9.2 Purchaser shall be ensured of the producer’s quality
greater than 3 in.2(1935 mm 2). Mechanical properties of forgings having greater
cross sections shall be negotiated between the manufacturer and the purchaser. program conforms to the intent of ASQ C1, or other recognized
B
Reduction of area not required for tubing.

TABLE 4 Mechanical Requirements: Annealed-Sheet, Strip, and Plate

Tensile Strength,A min Yield Strength,A (0.2 % Offset) Bend TestB
Elongation in 0.070 to
min max Under 0.070
Grade 2 in. or 50 0.187 in. (1.8
ksi MPa in. (1.8 mm)
mm, min,% to 4.75 mm)
ksi MPa ksi MPa in Thickness
in Thickness
1 35 240 25 170 45 310 24 3T 4T
2 50 345 40 275 65 450 20 4T 5T
3 65 450 55 380 80 550 18 4T 5T
4 80 550 70 483 95 655 15 5T 6T
A
Minimum and maximum limits apply to tests taken both longitudinal and transverse to the direction of rolling. Mechanical properties for conditions other than annealed
or plate thickness over 1 in. (25 mm) may be established by agreement between the manufacturer and the purchaser.
B
T equals the thickness of the bend test specimen. Bend tests are not applicable to material over 0.1875 in. (4.75 mm) in thickness.

a strain rate of 0.003 to 0.007 in./in. (mm/mm)/min through the program.

specified yield strength, and then the crosshead speed shall be
increased so as to produce fracture in approximately one 10. Keywords
additional minute. 10.1 metals (for surgical implants); orthopaedic medical
7.4 Any other special requirements shall be specified on the devices; titanium alloys; titanium/titanium alloy; titanium/
purchase order. titanium alloys (for surgical implants)

SUPPLEMENTARY REQUIREMENTS

These requirements shall apply only when specified in the purchase order, in which event the
specified tests shall be made by the manufacturer before shipment of the sheets or plates.

S1. Surface Requirements Bend Tests than full material thickness; however, the outer surface of the
S1.1 The purpose of this test is to measure the cleanliness or specimen must be representative of the product as supplied.
ductility, or both, of the metal surface. S1.4 The bend radius will be such to provide minimum
S1.2 Two-guided or free-bend tests of sheet or plate mate- elongation of the outer fibers of the bent specimen as follows:
rial limited to Grades 1, 2, and 3 shall be made. Each of these Grade 1—20 % equivalent to 2T bend radius at 180° bend
bends will place opposite surfaces of the sheet or plate material Grade 2—20 % equivalent to 2T bend radius at 180° bend
in tension. Grade 3—16 % equivalent to 21⁄2 T bend radius at 180° bend
S1.3 The bends are to be made in accordance with Test S1.5 Criteria for acceptance will be the absence of any
Method E 290, except that the welds mentioned in these cracking or surface separations (not originating at the edge of
standards are not required. The bend specimen may be of less specimen).

3
 Licença de uso exclusivo para Sistema de Implante Nacional Ltda.

F 67 – 00
APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 The primary reason for this standard is to characterize X1.3 Table 1 was condensed to have the same chemical
composition and properties to ensure consistency in the starting requirements for flat product and bars and billet. This is
material used directly or as modified by forging in the consistent with current commercial practice for unalloyed
manufacture of medical devices. titanium.
X1.2 The choice of composition and mechanical properties
is dependent upon the design and application of the medical
device.

X2. BIOCOMPATIBILTY

X2.1 The unalloyed titanium compositions covered by this X2.2 No known surgical implant material has ever been
specification have been employed successfully in human im- shown to be completely free of adverse reactions in the human
plant applications in contact with soft tissue and bone for over body. Long term clinical experience of the use of the materials
a decade. Due to the well characterized level of biological referred to in this specification, however, has shown that an
response exhibited by these unalloyed titanium materials, they acceptable level of biological response can be expected, if the
have been used as control materials in Practice F 981. material is used in appropriate applications.

ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned
in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk
of infringement of such rights, are entirely their own responsibility.

This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and
if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards
and should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of the
responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should
make your views known to the ASTM Committee on Standards, at the address shown below.

This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,
United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the above
address or at 610-832-9585 (phone), 610-832-9555 (fax), or service@astm.org (e-mail); or through the ASTM website
(www.astm.org).