Designation:F67–00
Standard Specification for
Unalloyed Titanium,for Surgical Implant Applications(UNS R50250,UNS R50400,UNS R50550,UNS R50700)1,2
This standard is issued under thefixed designation F67;the number immediately following the designation indicates the year of original adoption or,in the ca of revision,the year of last revision.A number in parenthes indicates the year of last reapproval.A superscript epsilon(e)indicates an editorial change since the last revision or reapproval.
正确佩戴口罩1.Scope
1.1This specification covers the chemical,mechanical,and metallurgical requirements for four grades of unalloyed tita-nium ud for the manufacture of surgical implants.
1.2The values stated in inch-pound units are to be regarded as the standard.
2.Referenced Documents
2.1ASTM Standards:
B265Specification for Titanium and Titanium Alloy Strip, Sheet,and Plate3
B348Specification for Titanium and Titanium Alloy Bars and Billets3
B381Specification for Titanium and Titanium Alloy Forg-ings3
凉拌紫甘蓝的做法E8Test Methods for Tension Testing of Metallic Materials4 E120Test Methods for Chemical Analysis of Titanium and Titanium Alloys5
E290Test Method for Semi-Guided Bend Test for Ductil-ity of Metallic Materials4
E527Practice for Numbering Metals and Alloys6
E1409Test Method for Determination of Oxygen in Tita-nium Alloys by the Inert Gas Fusion Technique7
E1447Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by the Inert Gas Fusion Thermal Conductivity Method7
F981Practice for Asssment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone8
F1341Specification for Unalloyed Titanium Wire for Sur-gical Implant Applications8
2.2Aerospace Material Specification:
AMS2249Chemical Check Analysis Limits,Titanium and Titanium Alloys9
2.3American Society for Quality(ASQ)Standard:
C1Specifications of General Requirements for a Quality Program10
不可撤销22.4Society of Automotive Engineers Standard:
SAE J1086Practice for Numbering Metals and Alloys (UNS)9
3.Product Classification
3.1Product classifications are consistent with Standard Specifications B265,B348and B381.
3.1.1Strip—Any product0.1875in.(
4.75mm)and under in thickness and less than24in.(610mm)in width.
3.1.2Sheet—Any product0.1875in.(
4.75mm)and under in thickness and24in.(610mm)or more in width.
3.1.3Plate—Any product0.1875in.(
4.75mm)in thickness and over10in.(254mm)in width.
3.1.4Bar—A hot rolled,forged,or cold worked mi-finished solid ction product who cross ctional area is equal to or less than16in.2(10322mm2);rectangular bar must be less than or equal to10in.(254mm)in width and greater than0.1875in.(
4.75mm)in thickness.
3.1.5Billet—A solid mi-finished ction hot rolled or forged from an ingot,with a cross ctional area greater than16 in2(10322mm2)who width is less than5times its thickness.
3.1.6Forging—Any product of work on metal formed to a desired shape by impact or pressure in hammers,forging machines,upt press or related forming equipment.
3.1.7Wire—Coiled round and non-round product with a diameter or major dimension equal to or greater than0.3130in. N OTE1—Wire less than or equal to0.3125in.in diameter or major dimension is covered in ASTM F1341.
3.1.8Other—Other forms and shapes,including tubing, may be provided by agreement between purchar and sup-plier.
1This specification is under the jurisdiction of ASTM Committee F04on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12on Metallurgical Materials.
Current edition approved May10,2000.Published August2000.Originally published as F67–66.Last pr
evious edition F67–95.
2New UNS designation established in accordance with E527and SAE J1086.
3Annual Book of ASTM Standards,V ol02.04.
4Annual Book of ASTM Standards,V ol03.01.
5Annual Book of ASTM Standards,V ol03.05. 6Annual Book of ASTM Standards,V ol1.01. 7Annual Book of ASTM Standards,V ol3.06. 8Annual Book of ASTM Standards,V ol13.01.
9Available from Society of Automotive Engineers,400Commonwealth Drive, Warrendale,PA15096.
数学方法10Available from American Society for Quality Control,161W.Wisconsin Ave., Milwaukee,WI53203.
1
Copyright©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959,United States.
4.Ordering Information
4.1Inquiries and orders for material under this specification shall include the following information:
4.1.1Quantity (weight or number of pieces),4.1.2Grade (1,2,3,or 4),4.1.3ASTM designation,
4.1.4Form (sheet,strip,plate,bar,billet,forging,wire or other forms),
4.1.5Condition (
5.1),
4.1.6Mechanical properties (if applicable,for special con-ditions),
4.1.7Finish (
5.2),
4.1.8Applicable dimensions and tolerances including size,thickness,width,and length (exact,random,multiples)or drawing number,
4.1.9Special tests,and
4.1.10Special requirements.
5.Manufacture
5.1Condition —Material shall be furnished in the hot-rolled,cold-worked,forged,annealed or stress relieved condi-tion.
5.2Finish —Unalloyed titanium material shall be free of injurious external and internal imperfections of a nature that will interfere with the purpo for which it is intended.Material may be furnished as descaled,as pickled,as sand-blasted,or as ground,or combinations of the operations.The manufacturer shall be permitted to remove minor surface imperfections by spot grinding if such grinding does not reduce the dimension below the minimum permitted by the dimen-sional tolerance ordered.
6.Chemical Composition
6.1The heat analysis shall conform to the requirements as to chemical composition prescribed in Table 1.Ingot analysis may be ud for reporting all chemical requirements except hydrogen,samples of which shall be taken from the finished product.Supplier shall not ship material that is outside the limits specified in Table 1for the applicable grade.
6.1.1Requirements for the major and minor elemental constituents are listed in Table 1.Also listed are important residual elements.Analysis for elements not listed in Table 1is not required to verify compliance with this specification.6.2Product Analysis —The product analysis is either for the purpo of verifying the composition of a heat or lot or to determine variations in the composition within the heat.
6.2.1Acceptance or rejection of a heat or lot of material may be made by the purchar on the basis of this product analysis.
6.2.2Product analysis tolerances do not broaden the speci-fied heat analysis requirements but cover variations between laboratories in the measurement of chemical content.Product analysis limits shall be as specified in Table 2
6.3For referee purpos,Test Methods E 120,E 1409and E 1447shall apply.
6.3.1Samples for chemical analysis shall be reprentative of the material being tested.
N OTE 2—Precaution:Extreme care must be taken in sampling titanium for chemical analysis becau of its affinity for elements such as oxygen,nitrogen,and hydrogen.Therefore,when cutting sa
mples for analysis,the operation should be carried out in a dust-free atmosphere,if possible.Chips should be collected from clean metal.Cutting tools should be clean and sharp.Samples for analysis should be stored in suitable containers.
7.Mechanical Requirements
7.1Bar,billet,and forging shall conform to the mechanical property requirements prescribed in Table 3.Sheet,strip,and plate shall conform to the mechanical property requirements prescribed in Table 4.Grades may be ordered in the cold-worked condition to higher minimum tensile strength but a minimum 10%elongation in 4D or 2in.(50mm)must be met.7.2For sheet and strip,the bend test specimen shall with-stand being bent cold through an angle of 105°without fracture in the outside of the bent portion.The bend shall be made on a diameter equal to that shown in Table 4for the applicable grade.
怎么看路由器密码7.2.1Supplementary bend test requirements for sheet and plate are listed in S1.
7.3Tension testing shall be performed in accordance with Test Methods E 8.Tensile properties shall be determined using
TABLE 1Chemical Requirements
Element Composition A ,%(mass/mass)
Grade 1Grade 2Grade 3Grade 4UNS R50250
UNS R50400
UNS R50550
UNS R50700
Nitrogen,max 0.030.030.050.05Carbon,max 0.080.080.080.08Hydrogen,max B 0.0150.0150.0150.015Iron,max 0.200.300.300.50Oxygen,max 0.180.250.350.40Titanium
balance
balance
balance
balance
A Forgings are designated Grade F-1,F-2,F-3,or F-4respectively.Forging compositions are as specified in Table 1.B
义工联Maximum hydrogen content for billet is 0.0100wt%.
TABLE 2Product Analysis Tolerances A
Element
Limit or Maximum of Specified Range %,
(mass/mass)
Tolerance Under the Minimum or Over the Maximum Limit B
Nitrogen up to 0.050.02Carbon 0.100.02Hydrogen up to 0.0150.0020Iron up to 0.250.10Iron over 0.250.15Oxygen up to 0.200.02Oxygen
over
0.20
0.03
A Refer to AMS 2249.
B
Under minimum limit not applicable for elements where only a maximum percentage is
indicated.
a strain rate of 0.003to 0.007in./in.(mm/mm)/min through the specified yield strength,and then the crosshead speed shall be incread so as to produce fracture in approximately one additional minute.
7.4Any other special requirements shall be specified on the purcha order.
8.Certification
8.1The manufacturer’s certification that the material was manufactured and tested in accordance with this specification together with a report of the test results shall be furnished to the purchar at the time of shipment.
9.Quality Program Requirements
9.1The producer shall maintain a quality program,such as,for example,is defined in ASQ C1.
9.2Purchar shall be ensured of the producer’s quality program conforms to the intent of ASQ C1,or other recognized
program.
10.Keywords
10.1metals (for surgical implants);orthopaedic medical devices;titanium alloys;titanium/titanium alloy;titanium/titanium alloys (for surgical implants)
SUPPLEMENTARY REQUIREMENTS
The requirements shall apply only when specified in the purcha 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
S1.1The purpo of this test is to measure the cleanliness or ductility,or both,of the metal surface.
S1.2Two-guided or free-bend tests of sheet or plate mate-rial limited to Grades 1,2,and 3shall be made.Each of the bends will place opposite surfaces of the sheet or plate material in tension.
S1.3The bends are to be made in accordance with Test Method E 290,except that the welds mentioned in the standards are not required.The bend specimen may be of less
than full material thickness;however,the outer surface of the specimen must be reprentative of the product as supplied.S1.4The bend radius will be such to provide minimum elongation of the outer fibers of the bent specimen as follows:Grade 1—20%equivalent to 2T bend radius at 180°bend Grade 2—20%equivalent to 2T bend radius at 180°bend Grade 3—16%equivalent to 21⁄2T bend radius at 180°bend S1.5Criteria for acceptance will be the abnce of any cracking or surface parations (not originating at the edge of specimen).
TABLE 3Mechanical Requirements:Annealed-Bar,Billet,
Forging,Wire and Other Forms A
Grade
Tensile Strength,
min Yield Strength,0.2%Offt,
min Elongation in 4D ,min,
%
Reduction of Area,min,%B
ksi
MPa ksi MPa 1352402517024302503454027520303654505538018304
80
550
70
483
15
25
A
The properties apply to forgings having a maximum cross ction area not greater than 3in.2(1935mm 2).Mechanical properties of forgings having greater cross ctions shall be negotiated between the manufacturer and the purchar.B
Reduction of area not required for tubing.
TABLE 4Mechanical Requirements:Annealed-Sheet,Strip,and Plate
Grade
Tensile Strength,A min
Yield Strength,A (0.2%Offt)Elongation 50mm,min,%
Bend Test B
ksi MPa
min
max
Under 0.070
in.(1.8mm)
大连海之韵公园
in Thickness
0.070to
0.187in.(1.8
to 4.75mm)
in Thickness
ksiqq升级最新版本
MPa ksi MPa 1352402517045310243T
4T 2503454027565450204T 5T 3654505538080550184T 5T 4
80
55070
483
95
655
15
5T 6T
A
Minimum and maximum limits apply to tests taken both longitudinal and transver to the direction of rolling.Mechanical properties for conditions other than annealed
or plate thickness over 1in.(25mm)may be established by agreement between the manufacturer and the purchar.B
T equals the thickness of the bend test specimen.Bend tests are not applicable to material over 0.1875in.(4.75mm)in
thickness.
APPENDIXES (Nonmandatory Information) X1.RATIONALE
X1.1The primary reason for this standard is to characterize composition and properties to ensure consistency in the starting material ud directly or as modified by forging in the manufacture of medical devices.
X1.2The choice of composition and mechanical properties is dependent upon the design and application of the medical device.
X1.3Table1was condend to have the same chemical requirements forflat product and bars and billet.This is consistent with current commercial practice for unalloyed titanium.
X2.BIOCOMPATIBILTY
X2.1The unalloyed titanium compositions covered by this specification have been employed successfully in human im-plant applications in contact with soft tissue and bone for over a decade.Due to the well characterized level of biological respon exhibited by the unalloyed titanium materials,they have been ud as control materials in Practice F981.
X2.2No known surgical implant material has ever been shown to be completely free of adver reactions in the human body.Long term clinical experience of the u of the materials referred to in t
his specification,however,has shown that an acceptable level of biological respon can be expected,if the material is ud in appropriate applications.
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