'~~ Designation: F 67 - 95

Standard Specification for

Unalloyed Titanium for Surgical Implant Applications 1
Th~ S1a1ldard is iSl>"edunder 1M fixed desi&natioft F' 67; the nunlh6 immediately Ibllowing [t!~ IJo:signation md;...a1CSthe year of
original aOopIion or. in Ihc case of ",vision. !!>eyear or ]a.,t A:vision. A number in pamlth~ indicates I~ year oflaS' .upprov'i1i. /I,
supe",..'l'ipt ~Ion (n indi= an roiloria) challlll" !liner lh.. Ian ",v;';,," or ppruval.

J. Scope to the requirements of the latt::Stissues of Specifications

1.1 This specification covers ,he chemical, mechanical, B 265, B 34!t and B 381.
--n '(11 the case~c a conflict exists between this
and metallurgical requirements fOTfour grades of unAilloycd
titanium used for the manufacture of surgica.limplants. specification and lhose listed in 3.1, this spcdficatjon shall
1.2 The values stated in incb-pound unilS are to be take precedence.
regarded as the standard.
4. OrderiDg InformatiOd
2. hterem:ed I)o(wnentS 4.1 Inquiries and orders for material under this specifica-
tion shall include tbe following information:
2.1 ASTM Standards: 4.1.1 Quantity (weight or number of pieces).
B 265 Specification for Titanium and Titanium Alloy 4.1.2 Grade (t, 2. 3, or 4),
Strip, Sheet, and Plate2 4.1.3 ASTM designation,
B 348 Specification for Titanium and Titanium Alloy Bars 4.1.4 Fonn (sheet. strip, plate. bar, billet, or forging),
and BiUets2 4.1.5 Condition (5.1),
B 381 Specification for Titanium and Titanium Alloy 4.1.6 Mechanical properties (if applicable, for special
Forging,s2 conditions),
E 8 Test Methods for Tension Testing of Metallic 4.1.7 Finish (5.2),
.
,: Materials) 4.1.8 Applicable dimensions including !)ize, thickness,
/'"' '\ E 16 Methods of Free Bend Test for Ductility of Welds4
width, and length (exact, random, multiples) or print
.'E 120 Test Methods for Chemical Analysis of Titanium number,
and Titanium Alloys' 4.1.9 Special tests. and
, 'E190 Test Method fOTGuided Bend iest for Ductility of 4.1.10 Special requirements.
.
Welds:\
E 290 Test Method for Semi-Guided Bend Test for
Ductility of Metallic Materials) 5. Manufacture
F 981 Practice for Assessment of Compatibility of 5.1 Condition-Material shall be furnished to the implant
"
Biomaterials for Surgical Implants with Respect to manufacturer in the hot-rolled, cold-worked, forged. or
Effect of Materials on Muscle and Bone6 annealed condition.
, 2.2 AeroJpace MaJ.erialSpecification; 5.2 Finish-Unalloyed titanium material shall be free of
AMS' 2249C C1temical Check Analysis limitS, Titanium injurious external and internal imperfections of a nature that
and Titanium Alloys7 will interfere with tbe purpose for which it is intended.
. 2.3 A.meriam Society for Qualiry CQntrol (ASQC) Stan- Annealed material may be furnished as descaJed. as sand.
_' dard: blasted, or as ground. or both sandblasted and ground. If
. CI-1985 Specifications of General RequirementS for a shipped as bot roUed, descalcd, sandblasted, or ground, the
. Quality ProgramS manufacturer shan be pennitted \0 remove minor surface
imperfections by spot grinding if such grinding does not
3. General Requirements for Deliyery reduce the thickness of the material below the minimum
pennitted by the tolerance for lhe thickn~ ordered.
3.1 Material furnished to this specification shail conform
6. Chemical Composidoo
J This
sPecificauon is unl!r.r the juri~iction of ASTM Committee. F...4 6.1 The heat analysis shan confonn to the requirements as
McctiCid and Surgical M:I\t:ria1s and DcYi~ ~nd is lhc direct =po>nsibilily ""
of
Sutl\:ommittee F()4.12 on MetaiJUIJicuJ Matc:tials.
to chemical composition prescribed in Table 1. Ingot anal-
CUITl!llt edition ilC)SWOvedFeb. '5. 1')'1$. Published April 1995. Oripnally ysis may be used for reporting all chemical requirements
publi$hcd ~
f' 67 -
2 Annr.m Book
66. Last previous edition F 61 - K9 (1994)"'. except hydrogen, samples of which shall be taken from the
qf".STM Sra"da,d.t. Vol 02.04. finished product.
3 AM,,"I 8(1i)/cof AS']'.\{ Sial.daftl..., Vol OJ,0 I.
. DilCon,jnued-Sc:
1977 An"um Book "f.4STM SluntiardI. P'~T1 10.
6.1.1 Requirements for the major and minur elemental
,
AltJlwV Book of ASTM !>}aroda,dI.Vol 0).05. constituents are listed in Table I. Also listed are importam
6 Qf ASTM Slallda,ds, VoIIJ.OI.
An"uIII Book
7 Available f,om So<,.;etyof Aulomoti"~ ~nsinttl'S. 4()() CommonwQ!ltl Drive.
residual clements. Analysis for elements not listed in Table I
is not required to verify compliance with this specification.
Wm-e'KSak. PA 15096.
. A~labic from AmenC<lQ SP\.i.:ly rOt Qllalit~ Comru]. 161 W. Wj1;Consin 6.2 Product AnQ'y~'is-Produc\ analysis tolerances do Dot
Ave.. Milwaukee. WI 53203. broaden the specified heat analysis requirements, but cover

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.
-'

~. ., F67
TABLE 1 CMmIc8I R*IU\rementli 7
C«npo&ilion." to the
Gr8de 1 Gt!lde 2 (flde 3 GrIlle 4
Flal Proo.a Bar 8nCIBillet Flal F'rocJwd Bar IInd BiIIBt Rat ProcU:\ 8It 8Id 6IIIIt FIll PIocU:t Ber ItId BIIet
8. I

NttrogBn max 0.03 0.03 0.03 0,03 0.05 0.06 0.0& 0.05 8
camon ~ 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 ma:
~. mu 0.015 0.01258 0.01$ 0.D125- 0.015 0.01258 0.015 0.0125- tior
Iron. 11\8II 0.20 0.20 0.30 0.30 0.30 0.30 0.50 0.50 nist'
Oxygen. male 0.18 0.18 0.25 0.25 0.35 0.35 0.40 0.40
TlIltlium ba\eIQ oa18nC8 bBIaIIce balance bBllIIQ D8I8nC& b8IIrce baIIncB
9. I
.. f"orging& BrillQeSigT'laladGrllde F-1. F-2. F-3. 01 F-4 reS()8C1ively.Forging ~6 srelCJ8nlicallo II\O$e epec:IIIedror IIat 1)IOducl.
9 B8r only: maximum hyO'ogerI oontenr IOf billet is 0.0100 ~. C.

TA8LE 2 Product "-.,... ToIer1Inces.a TABt.E 3 Mec:tl8l1Ic81R~, III8t, end FcqIng~

TOI8r8'1Ce LiId8r !he T SftngIh. YI8Ids 0.2 $
Umfl or Maximum d iIcftgaIIan81 Ae.b:IIon d
~ or Ower tn8 0If88l
~Aange. $ "*' 40. AIw.-. s
MPimuItIIJmiID kr;j MPI IEai .... "*'- "
NitroIJIn up toO.OS 0.02
0.02
1 35 Z<IO 25 170 24 30 SJ.
Cnon 0.10
2 SO 345 40 m 20 30
HydrogrIn 14' to 0.015 0.0020
!ton up 10 0.25 0.10
3 65 460 5& 380 18 30 S
QIIIt 0.25
4 80 S50 70 43 15 2S or l
Iron 0.15
0sygef1 up In 0.20 0.02 ,Itn-e prop8I1IeIJ ~ to ~ t ng I mexIIvn atIII MI:\ign not ~.
Oxygen Oller 0.20 0.03 grB9!eI'II'Iotn:) 8\,2(1g:JSmm2).Mo..J propertIe$d fDr9n9' MWIg
~ ma
.. R8I8' to AMS22.QC. cross ~ 8118II11II
nsgotIII8d bIIIwWI!he ~ IIId !IIe~.
the
IIIt.rdBr mM1II'/IumIlmil not eppIioebie b \$ wI'IenIanty a maximUm
perallf'18g8it;indiI:8Ied. . ma'
1. Mechanical Reqaireme. (:
7.1 Bar, billet. and forging shaD confonn to the appro- M(
variations between Jabol1ltories in the measurement of chem- priate requirements as to mechanical properties prescribed in ti()!
~cal content. The manufacturer shall not ship material that is Table 3. Sbeet. strip, and platt shall conform to the me
;ulSide the limits specified in Table 1 for applicable grade. appropriate requirements as to mechanical properties pn>-
Product anaJysis limits sball be as specified in Table 2. scribed in Tab1e 4. Grades 3 and 4 may be ordered in the
6.2.1 The product analysis is either for the puJPOSe of cold.worked condition to higher nnnimum teo5ile smngth
verifying the composition of a beat or lot or to determine but a minimum 10 % elongation in 4D or 2 in. (SO mm)
variations in the composition within the heaL must be met.
6.2.2 Acceptanoo Or rejec1ion of a heat or lot of material 7.2 For sheet and strip,lbc bend test specimen shall stand
may be made by tbe purchaser on the basis of this check being bent cold through an aD8leof 1058without fr3cture in
analysis. the outside afthe bent portiOIl.Tbe bend shall be ma4e on a I
6.3 For referee purposes. Test Methods E 120 shall apply. diameter equal 10 that shown in Table 4 for the applicable
6.3.1 Samples fOrchemical analysis shall be representative grade. , ter:
of the matenal being te$ted. Extreme care must be taken in 7.2.1 SuwlementaJ'y bend test reqtriremenlS (or sheet and
sampling titanium for chemical analysis because of its ~the
plate are listed in S 1. m'
affinity for elements such as oxygen, nitrogen, and hydrogen. 7.3 Perform tension testing in accordaoce with Test
Therefore, when cutting samples fOf analysis, the operation Methods E 8. Determine tensile properties using a strain nile t bel
i
sbould be ca.rried out in a dust-free atmosphere, if possible.. of O.l)()3to 0.001 jn./in. (mm/mm). min thtoUSh the speci. I bit
Chips should be collected from dean mew. Cutting tools
ibould be clean and sharp. Samples for analysis sbould be
tied yield strength. and then the crosshead speed shall be
increased so as to produce fracture in approximately One
,;
i bet
stored in suitable con1ainen. additionaJ minute. I tie~
(
I
TAIN.E 4 Mechanical Requiremeftta-Sheet. Strip, Ind PI8_ !
Y1BId S1rengI/'t." (0.2 % 0II!;et) &end Test8
aongation In 2 007010 0187
mJn
11'I.Of 50 !mi. LkGIf 0.070 81. ~. (1.8 to 4.75
MPs
kSi
k$l MPs kSi MPa
min. $ (~~~
u__ rnm) In
TI1ICknea8 I
1 3S 240 2S 170 45 310 24 3T 4T
2 50 345 40 275 65 4S0 20 4T 5T
:J 65 450 55 380 80 S50 18 4T 5T
.. 80 550 70 483 9S 655 15 $1 6T
.. MInImum and maximum ItnIts 8PDIY10 testa 11IAM! bo1h IOngItWit14Ii8I'tIS1IUn"'__ 10!he dir8cIion 0' rcfrng. MedIar*:8I ~ lor COIIIOorIsCJCh8rINrIIIM8II8d
or /lllte thiI:kntsI; ovor 1 in. (25 mm) may I)e eeUlbll8hOGby IIUIWII18I,Ibet\IIIMn!he ~ and!he~.
& T equalS !he tllickrws$ of \he bQnd tesl apecim8n. Beno 111$15are not appIicebIe 10 malef1ll o'ler 0.187 in. (4.7SI'l'ln)in~.

'-'22:"["[
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 7.4 Any other special requirements shaH be specified on
. F61
the implant manufacturer's purchase order.
8. CertifkatloD
8.1 The manufacturer's certification that the material was
manufactured and I.esled in accordaoce with this specifica.
tion tOgether witb a report of the test results sbaU be fur-
nished to the implant manufacturer at the time of shipment.
9. Quality Program Requirements
9.1 The producer shall maintain a quality program, such
as. for example. is defined in ASQC Cl-)985.
9.2 The manufacturer of surgical implants or medical
appliances shall be ensured of the producer's quality pro-
gram for conformance to the intent of ASQC CI-1985, or
other ~ized program.
10. Keywords
10.1 metals (for surgical implants); onhopaedic medical
devices; titanium alloys; titanium/titanium alloy; titaniuml
titanium alloys (for surgical implants)

SUPPLEMENTARY REQUIREMEN'IS

These: requirements shall apply only when specified in the purchase order, in which event the specified tests
sha1I be made by the manufacturer before shipment of tbe plates.

51. Surface Requiremetlts Bend Tests
S1.1 Tbe purpose of this test is to measure the cleanliness
or ductility. or both. of the metal surface.
SJ.2 Tw<>-guidcd or free.bend tests of sheet or plate
material limited to Grades 1, 2. and 3 shall be made. Each of
these bends will place opposite surfaces of the sheet or plate
material in tension.
S1.3 The bends are to be made in accordance with Test
Method E J90 or Methods E 16, except that the welds men-
tioned in these standards arc not required. The bend sperl.
~, men may be of less than full material thickness; however. the
outer surface of the specimen must be representative of the
product as supplied..
S 1.4 The bend r.tdius will be sucb to provide minimum
elongation of the outer fibers of the bent specimen as follows:
Grade J-20 % equivalent to 2T bend radius at IS08 bend
Grade 2-20 % equivalent to 2T bend radius at ISO-bend
Grade 3-16 % equivalent to 211% T bend radius at 180" bend
S1.5 Criteria fOTacceptance will be the absence of any
cracking or surface separations (not originating at the edge of
specimen).

APPENDIX

(NODIII8IIdatory Information)

XI. RATIONALE
X J.l The primary reason for this standard is to charac-
terize composition and propenies to ensure consistency in
the starling material used directly or as modified by forging
in tbe manufacture of medical devices.
X 1.2 The material compositions specified herein have
been shown to produce a weU<baracterized level of local
biological response fonowing long-tcnn l,,-tinicaJuse and bas
been used as control material in Practice F 981.
X 1.3 The choice of composition and. mechanical proper-
lies is dependent upon the design and application of the
medical device.
XL4 A maximum limit for 0.2 % offsetyieJd strength has
been added to the mechanical requirements for sheet, strip,
and plate to coincide with Specification B 265.
X1.5 Tbe bend test sample thickness limits previously
specified were inCOITect.Supplementary bend test require-
mentS have been added in accordanc:c with Specification
B265.
X).6 Additional product analysis tolerance information
has been included for clarificatiODpurposes.

The Amsrican SocSeIy lor TBBli"9 snd Malerialti taJtes no position respecting rile WIIldily of any pamnl r/ghlfl .-red In conneetJon
wIIft any It#lffl~ In llIi$ $larrlJtArCl.
VStfS of Iflls SlW!<18fCl
lIf. 'IlpIWUI'f .t1vi$e6 1118/~"mJtWion at tile .",idity alcmy such
patGnl rig/lt$. ltfId llIe risk of i1tfri~ aI t;uch righfB. _ entir9ly tlr9ir own rssponsibility.

TIIIa "a1I(1.r<l1$SIIO/«I 10 ,..,1$/011 /1/ O/Iy Ii",. Oy tile rN(JCMM tflcfltliclJt commmee MIS must bit r9lfiswed 9If1lJrffills YO81'S#IfId
if no! rwised. s;,hfJf reapptf1tffId or withdrawn. Your comments are /rNfted eIItIer lor relrlalon ot tIti, $J8/tQ8f/1 or tor atk1HiOIW stlndan13
and should bit 8I1dressed to ASTM HfNIdquarrers. Your CO/ITII'ItIIIS Will ~ Uftful COMk1fIrlJlion It . -mg of Ih& respot!tl/bI9
ItCMiCa/ cO/l1lnitree. wltitfl you may Mtend. if you feel Ihllt your communis have no! rBCBlved s fIlJr heerlflg you ,fIOUIa m.tk. 'fOUr
views known 10 Ihe ASTM Commill99 an Srlllldart1s, 1916 Race $r.. ""tlS"efpllla, PA 19103.

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