1、Designation: F 1580 01Standard Specification forTitanium and Titanium-6 Aluminum-4 Vanadium AlloyPowders for Coatings of Surgical Implants1This standard is issued under the fixed designation F 1580; the number immediately following the designation indicates the year oforiginal adoption or, in the ca
2、se of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for unalloyedtitanium and Ti-6Al-4V alloy pow
3、ders for use in fabricatingcoatings on titanium alloy implants.1.2 Powders covered under this specification may be used toform coatings by sintering or thermal spraying techniques.1.3 This specification covers powder requirements only. Itdoes not address properties of the coatings formed from them.2
4、. Referenced Documents2.1 ASTM Standards:B 214 Test Method Sieve Analysis of Granular Metal Pow-ders2B 215 Practices for Sampling Finished Lots of Metal Pow-ders2B 299 Specification for Titanium Sponge3E11 Specification for Wire-Cloth Sieves for Testing Pur-poses4E 120 Test Methods for Chemical Anal
5、ysis of Titanium andTitanium Alloys5F67 Specification for Unalloyed Titanium for SurgicalImplant Applications6F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants With Respect to Effect ofMaterials on Muscle and Bone6F 1472 Specification for Wrought Ti-6Al-4V Alloy f
6、or Sur-gical Implant Applications62.2 American Society for Quality (ASQ) Standards:7ASQ C1 General Requirements for a Quality Program2.3 Aerospace Material Specifications:8AMS 2249 Chemical Check Analysis Limits, Titanium andTitanium AlloysAMS 4998A Powder, 6Al-4V, Premium Quality (noncur-rent)3. Me
7、thods of Manufacture3.1 Powders may be manufactured by the plasma rotatingelectrode process, inert gas atomization, hydride-dehydride, orother method capable of producing powder meeting the re-quirements of this specification.4. Chemical Requirements Chemical Requirements4.1 The chemical analysis of
8、 the powder shall conform tothe requirements set forth in Table 1. Analysis shall beperformed before the addition of any processing aids.4.1.1 Requirements for the major and minor elementalconstituents for unalloyed titanium and Ti-6Al-4V alloy pow-ders are listed in Table 1. Also listed are all imp
9、ortant residualelements. Analysis for elements not listed in Table 1 is notrequired to verify compliance with this specification.4.2 The product analysis tolerance shall conform to therequirements set forth in Table 2.4.3 For referee purposes, Test Methods E 120 shall be used.4.4 Intentional element
10、al additions other than those speci-fied in Table 1 are not permitted.4.5 For powder that includes particle size fractions finerthan 200 mesh (74 m), the oxygen content limits shall beagreed upon between buyer and seller.5. Particle Size and Shape5.1 Powder shall be sieved to the customers requireme
11、ntswith stainless steel screens conforming to Specification E11.Analysis of sieved powder for conformance to the customersparticle size range requirements shall be in accordance withTest Method B 214.5.2 Powder made from the plasma rotating electrode pro-cess and inert gas atomization tends to be sp
12、herical in shape,1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Devices and is under the direct responsibility of Subcommit-tee F04.12 on Metallurgical Materials.Current edition approved October 10, 2001. Published January 2002. Orginallypublished as F 158
13、0 - 95. Plast previous edition F 1580 - 95e1.2Annual Book of ASTM Standards, Vol 02.05.3Annual Book of ASTM Standards, Vol 02.04.4Annual Book of ASTM Standards, Vol 14.02.5Annual Book of ASTM Standards, Vol 03.05.6Annual Book of ASTM Standards, Vol 13.01.7Available from the American Society for Qual
14、ity, 600 N. Plankinton Ave.,Milwaukee, WI 53203.8Available from Society of Automotive Engineers, 400 Commonwealth Dr.,Warrendale, PA 150960001.1*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 19
15、428-2959, United States.powder made from the hydride-dehydride process tends to beangular in shape and sponge powder tends to be irregular inshape.6. Cleanliness6.1 Powder shall be handled at all times so as to ensurefreedom from contamination with nonmetallic materials orother metal alloy powders o
16、r both.6.2 Powder cleanliness shall be determined by examining arepresentative sample, per Practices B 215 or as agreed uponbetween buyer and seller, comprising at least 1 in.2(6.45 cm2)of a closely packed mono-layer of powder per lot at 203magnification. No foreign material shall be visible under t
17、heseconditions. Powder cleanliness shall be determined before theaddition of any processing aids.7. Special Requirements7.1 Various materials known as processing aids may beadded to the powder to provide enhanced processibility. Thepowder supplier shall identify the chemical composition andweight pe
18、rcentage of any added processing aids on the materialcertification.7.2 Processing aids shall have no detrimental effect on thecorrosion resistance or biocomptability of the final coating.NOTE 1Finely divided titanium powder may be considered pyro-phoric and should be handled in accordance with the a
19、ppropriate guide-lines in the Material Safety Data Sheet.8. Certification8.1 Powder shipped under this specification shall be accom-panied by certification that includes:8.1.1 ASTM designation and date of issue.8.1.2 Quantity (weight).8.1.3 Method of manufacture.8.1.4 Chemical analysis per 4.1.8.1.5
20、 Sieve analysis per 5.1.8.1.6 Powder cleanliness per 6.2.8.1.7 Special requirement per 7.2.8.1.8 Other requirements.9. Quality Program Requirements9.1 The producer shall maintain a quality program, such asthat defined in the ASQ C1, for example.9.2 The manufacturer of surgical implants shall be ensu
21、redof the producers quality program for conformance to the intentof ASQ C1 or other recognized programs.10. Keywords10.1 coatings; metallic; metals (for surgical implants tita-nium alloys); orthopaedic medical devices (titanium/titaniumalloys); powder; porous coatings; titanium/titanium alloys (fors
22、urgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Coatings formed from metallic powders have becomewidely used as a means of improving tissue attachment touncemented orthopedic joint prosthesis. Such coatings havealso been demonstrated to improve bonding of acrylic cementto pros
23、theses. The method used to create the coatings candetermine which powder size and shape is suitable for thespecific application. Not all powder sizes or shapes areapplicable for all coating processes.X1.2 Chemical composition limits for O, Fe, C, and N inthe unalloyed grade are taken from Specificat
24、ion F67, Grade 4.Limits for Si, Cl, H, and Na are taken from SpecificationB 299, Grade SL.X1.3 Chemical composition limits for Al, V, O, Fe, C, H,and N in the Ti-6Al-4V grade are taken from SpecificationF 1472. Limits for Cu and Sn are taken from AMS 4998.TABLE 1 Chemical RequirementsElementUnalloye
25、d Ti PowderWeight PercentTi-6Al-4V PowderWeight PercentMin Max Min MaxAl 5.50 6.75V 3.50 4.50O 0.40 0.20Fe 0.50 0.30C 0.10 0.08H 0.05 0.015N 0.05 0.05Cu 0.10Sn 0.10Si 0.04Cl 0.20ANa 0.19ATi balanceBbalanceBALower maximum chlorine and sodium contents may be agreed upon betweenbuyer and seller.BThe pe
26、rcentage of titanium is determined by difference and need not bemeasured.TABLE 2 Product Analysis TolerancesAElement Variation Under Min or Over MaxAluminum 0.04Vanadium 0.015Oxygen 0.03BOxygen 0.02CIron 0.10Hydrogen 0.002Carbon 0.02Nitrogen 0.02Copper 0.05Tin 0.15Silicon 0.02ARefer to AMS 2249.BFor
27、 unalloyed Ti powder.CFor Ti-6Al-4V alloy powder.F1580012X1.4 Product analysis tolerances are taken directly fromAMS 2249. No recognized product analysis tolerances cur-rently exist specifically for Cl or Na in titanium alloys.X1.5 Processing aids are frequently used to facilitatepowder processing a
28、nd application of porous coatings toimplant surfaces. It is beyond the scope of this specification toidentify suitable processing aids or define their use. It is theresponsibility of the implant manufacturer to ensure that anyprocessing aid or residue of a processing aid has no detrimentaleffect on
29、biocompatibility or coating properties.X1.6 It should be recognized that the heat treatments usedto form porous coatings can create microstructures that aresubstantially different from wrought titanium alloys. Porouscoated implants also exhibit much greater surface area thanmonolithic implants. For
30、these reasons, the biocompatibilityand corrosion behavior must be characterized on finishedcoatings.X1.7 Likewise, these heat treatments can create microstruc-tures that give substantially different corrosion fatigue behaviorfrom that of typical wrought titanium alloys. Corrosion fatiguebehavior mus
31、t be evaluated on finished coated substrates.X1.8 Pore size and morphology are important factorsinfluencing tissue ingrowth and acrylic penetration of porouscoatings. Particle size, size distribution, and shape are criticalto controlling the pore size and morphology in the finalcoating. Particle siz
32、e and size distribution are conventionallycontrolled by screening. The referenced ASTM Internationalstandards allow comparison of powder to a manufacturersspecifications for a given coating process. A number ofmethods to characterize particle shape exists. The coatingmanufacturer should select a mea
33、ns of particle shape charac-terization suitable for his process.X1.9 This specification requires sampling for particle sizeand powder cleanliness on each powder lot. In some cases,sampling on each shipping container of powder may beappropriate.X1.10 Other process parameters are also critical to dete
34、r-mining final pore size and morphology in the final coating.Because these parameters are not directly related to thechemical and physical characteristics of the starting powder,they are not addressed in this specification.X1.11 The requirements for powder cleanliness ensurefreedom from contaminants
35、 that might adversely affect eitherthe biocompatibility or the finished coatings or the ability tobond the coating properly during manufacturing. The methodin 6.2 (Practices B 215) is commonly used for relatively coarsespherical powders used to fabricate sintered porous coatings.Other types of powde
36、rs may require different methods forcleanliness characterization. The development and implemen-tation of such methods are the responsibility of the implantmanufacturer.X2. BIOCOMPATIBILITYX2.1 The biocompatibility of metallic implants is a directfunction of their composition. The alloy compositions
37、coveredby this specification have been used in the wrought form forsurgical implants and have been used successfully in humanimplant applications in contact with soft tissue and bone forover a decade. Because of the well characterized level ofbiological response exhibited by these alloys, they have
38、beenused as a control material in Practice F 981.X2.2 No known surgical implant material has ever beenshown to be completely free from adverse reactions in thehuman body. Long-term clinical experience of the use of thematerial referred to in this specification, however, has shownthat an acceptable l
39、evel of biological response can be expected,if the material is used in appropriate applications.SUMMARY OF CHANGES(1) Added 6.2 concerning particle shape, eliminated Section 3and renumbered document, and added X1.1 in which powdershape and application is addressed.(2) Editorial corrections have been
40、 made to meet terminologyand formatting guidelines established for implant materialstandards.F1580013ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that det
41、ermination of the validity of any such patent rights, and the riskof 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 andif not revised, either reapproved o
42、r withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel th
43、at your comments have not received a fair hearing you shouldmake 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 aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F1580014
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