ASTM F1580-2012 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants 《外科植入物覆层用钛和钛-6铝-4钒合金粉末的标准规格》.pdf

1、Designation:F158007 Designation: F1580 12Standard Specification forTitanium and Titanium-6 Aluminum-4 Vanadium AlloyPowders for Coatings of Surgical Implants1This standard is issued under the fixed designation F1580; the number immediately following the designation indicates the year oforiginal adop

2、tion or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for unalloyed titanium and T

3、i-6Al-4V alloy powders for use in fabricatingcoatings on titanium alloy implants.1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques.1.3 This specification covers powder requirements only. It does not address properties of the coating

4、s formed from them.1.4Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriateguidelines.1.4 Finely divided titanium powder may be considered pyrophoric and should be handled in accordance with the appropriateguidelines.1.5 The values state

5、d in inch-pound units are to be regarded as standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information only and are not considered standard.2. Referenced Documents2.1 ASTM Standards:2B214 Test Method for Sieve Analysis of Metal PowdersB215 Pra

6、ctices for Sampling Metal PowdersB299 Specification for Titanium SpongeE11 Specification for Woven Wire Test Sieve Cloth and Test SievesE29 Practice for Using Significant Digits in Test Data to Determine Conformance with SpecificationsE2371 Test Method for Analysis of Titanium and Titanium Alloys by

7、 Atomic Emission Plasma SpectrometryF67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNSR50700) F981F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and Bon

8、eF1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)2.2 ISO Standards:3ISO 9001 Quality Management System Requirements2.3 American Society for Quality (ASQ) Standards:ASQC1General Requirements for a Quality Program2.4 Aerospace Material S

9、pecifications:4AMS 2249 Chemical Check Analysis Limits, Titanium and Titanium AlloysAMS 4998 Powder, 6Al-4V3. Significance and Use3.1 Coatings formed from metallic powders have become widely used as a means of improving tissue attachment to implants.Such coatings have also been demonstrated to impro

10、ve bonding of acrylic cement to prostheses. This specification addresses the1This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is under the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approv

11、ed Dec.March 1, 2007.2012. Published December 2007.March 2012. Originally approved in 1995. Last previous edition approved in 20012007 asF1580 - 017. DOI: 10.1520/F1580-07.10.1520/F1580-12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at servi

12、ceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from American Society for Quali

13、ty (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.4Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001, http:/www.sae.org.1This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an in

14、dication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be

15、 considered the official document.*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 19428-2959, United States.special requirements of the metal powders used to form these coatings.4. Methods of Ma

16、nufacture4.1 Powders may be manufactured by the plasma rotating electrode process, inert gas atomization, hydride-dehydride, or othermethod capable of producing powder meeting the requirements of this specification.5. Chemical Requirements5.1 The chemical analysis of the powder shall conform to the

17、requirements specified in Table 1.5.1.1 Requirements for the major and minor elemental constituents for unalloyed titanium and Ti-6Al-4V alloy powders arelisted in Table 1. Also listed are all important residual elements. Analysis for elements not listed in Table 1 is not required to verifycomplianc

18、e with this specification.5.2 The product analysis tolerance shall conform to the requirements set forth in Table 2.5.3For referee purposes, Test Method5.3 For referee purposes, Test Method E2371 shall be used.5.4 Intentional elemental additions other than those specified in Table 1 are not permitte

19、d.5.5 For powder that includes particle size fractions finer than 200 mesh (74 m), the oxygen content limits shall be agreed uponbetween buyer and seller.6. Particle Size6.1 Powder shall be sieved to the customers requirements with stainless steel screens conforming to Specification E11.Analysisof s

20、ieved powder for conformance to the customers particle size range requirements shall be in accordance with Test MethodB214.7. Cleanliness7.1 Powder shall be handled at all times so as to ensure freedom from contamination with nonmetallic materials or other metalalloy powders or both.7.2 Powder clean

21、liness shall be determined by examining a representative sample, per Practices B215 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 these conditions.8. Sig

22、nificance of Numerical Limits8.1The8.1 The following applies to all specified numerical limits in this specification. To determine conformance to these limits,an observed or calculated value shall be rounded to the nearest unit in the last right hand digit used in expressing the specificationlimit,

23、in accordance with the rounding method of Practice E29.TABLE 1 Chemical RequirementsElementUnalloyedTi PowderA% (mass/mass)Ti SpongePowderB% (mass/mass)Ti-6Al-4VPowderC% (mass/mass)Min Max Min Max Min MaxAl 0.05 5.50 6.75V 3.50 4.50O 0.40 0.40D0.20Fe 0.50 0.15 0.30C 0.08 0.03 0.08H 0.05 0.03 0.015N

24、0.05 0.02 0.05Cu 0.10Sn 0.10Si 0.04Cl 0.20ENaFY 0.005CTi balanceGbalanceGbalanceGAChemistry per Specification F67 except hydrogen.BChemistry per Specification B299, general purpose grade.CChemistry per Specification F1472.DOxygen per Specification B299 is 0.15 %. This level is reasonable for spongep

25、roduct but not for powder because of the increased surface area of small particlepowder product.ELower maximum chlorine content may be agreed upon between buyerpurchaser and seller supplier.FSodium or magnesium, 0.50 maximum.GThe percentage of titanium is determined by difference and need not bemeas

26、ured.F1580 1229. Certification9.1 Powder shipped under this specification shall be accompanied by certification that includes:9.1.1 ASTM designation and date of issue.9.1.2 Quantity (weight).9.1.3 Method of manufacture.9.1.4 Chemical analysis per 5.1.9.1.5 Sieve analysis per 6.1.9.1.6 Powder cleanli

27、ness per 7.2.9.1.7 Other requirements.10. Quality Program Requirements10.1The supplier shall maintain a quality program, such as that defined in the ASQ C1 or ISO9001, for example.10.2The purchaser shall be ensured of the suppliers quality program for conformance to the intent of ASQ C1 or otherreco

28、gnized programs.10.1 The supplier shall maintain a quality program, such as that defined in ISO 9001 or similar quality program.11. Keywords11.1 coatings; metallic; metals (for surgical implants titanium alloys); orthopaedic medical devices (titanium/titanium alloys);powder; porous coatings; titaniu

29、m/titanium alloys (for surgical implants)APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Coatings formed from metallic powders have become widely used as a means of improving tissue attachment touncemented orthopedic joint prosthesis. Such coatings have also been demonstrated to improve bondin

30、g of acrylic cement toprostheses.X1.2 The biocompatibility of metallic implants is a direct function of their composition. The compositions of titanium andtitanium alloy powders allowed by this specification have been used in wrought form for surgical implants and are in widespreadcommercial use for

31、 fabrication of porous coatings.X1.3 Chemical composition limits for oxygen, iron, carbon, and nitrogen in the unalloyed grade are taken from SpecificationF67, Grade 4. Limits for silicon, chlorine, hydrogen, and sodium are taken from Specification B299, Grade SL.X1.4 Chemical composition limits for

32、 aluminum, vanadium, oxygen, iron, carbon, hydrogen, and nitrogen in the Ti-6Al-4Vgrade are taken from Specification F1472. Limits for copper and tin are taken from AMS 4998.X1.5 Product analysis tolerances are taken directly from AMS 2249. No recognized product analysis tolerances currently existsp

33、ecifically for chlorine or sodium in titanium alloys.X1.6 Processing aids are frequently used to facilitate powder processing and application of porous coatings to implant surfaces.It is beyond the scope of this specification to identify suitable processing aids or define their use. It is the respon

34、sibility of theTABLE 2 Product Analysis TolerancesAElement Element Variation Under Min or OverMaxAluminum 0.04Vanadium 0.015Oxygen 0.03BOxygen 0.02CHydrogen 0.002Iron 0.10Carbon 0.02Nitrogen 0.02Copper 0.05Tin 0.15Silicon 0.02Yttrium 0.0005CARefer to AMS 2249.BFor unalloyed Ti powder.CFor Ti-6Al-4V

35、alloy powder.F1580 123implant manufacturer to ensure that any processing aid or residue of a processing aid has no detrimental effect on biocompatibilityor coating properties.X1.7 It should be recognized that the heat treatments used to form porous coatings can create microstructures that aresubstan

36、tially different from wrought titanium alloys. Porous coated implants also exhibit much greater surface area than monolithicimplants. For these reasons, the biocompatibility and corrosion behavior must be characterized on finished coatings.X1.8 Likewise, these heat treatments can create microstructu

37、res that give substantially different corrosion fatigue behavior fromthat of typical wrought titanium alloys. Corrosion fatigue behavior must be evaluated on finished coated substrates.X1.9 Pore size and morphology are important factors influencing tissue ingrowth and acrylic penetration of porous c

38、oatings.Particle size, size distribution, and shape are critical to controlling the pore size and morphology in the final coating. Particle sizeand size distribution are conventionally controlled by screening. The referenced ASTM International standards allow comparisonof powder to a manufacturers s

39、pecifications for a given coating process.Anumber of methods to characterize particle shape exists.The coating manufacturer should select a means of particle shape characterization suitable for this process.X1.10 This specification requires sampling for particle size and powder cleanliness on each p

40、owder lot. In some cases,sampling on each shipping container of powder may be appropriate.X1.11 Other process parameters are also critical to determining final pore size and morphology in the final coating. Becausethese parameters are not directly related to the chemical and physical characteristics

41、 of the starting powder, they are not addressedin this specification.X1.12 The requirements for powder cleanliness ensure freedom from contaminants that might adversely affect either thebiocompatibility or the finished coatings or the ability to bond the coating properly during manufacturing. The me

42、thod in 7.2(Practices B215) is commonly used for relatively coarse spherical powders used to fabricate sintered porous coatings. Other typesof powders may require different methods for cleanliness characterization. The development and implementation of such methodsare the responsibility of the impla

43、nt manufacturer.X2. BIOCOMPATIBILITYX2.1 The alloy composition covered by this specification has a long history of successful clinical application in soft tissue andbone implants in humans, with a well-characterized level of biological response.X2.2 No known surgical implant material has ever been s

44、hown to be completely free from adverse reactions in the human body.Long-term clinical experience of the use of the material referred to in this specification, however, has shown that an acceptablelevel of biological response can be expected, if the material is used in appropriate applications.SUMMA

45、RY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F158001)that may impact the use of this standard. (Approved Dec. 1, 2007.)Committee F04 has identified the location of selected changes to this standard since the last issue (F1580 07)th

46、at may impact the use of this standard. (Approved March 1, 2012.)The document was revised according to the template language:(1)Test Methods E120 is replaced with Test Method E2371 in 2 and 5.3. ) Section 10, revised to eliminate reference to ASQ C1.(2)Section 8 was renamed to Significance of Numeri

47、cal Limits.(3)Added 1.4 in Section 1.(4)Added ISO9001 in Section ) Section 2and Section 10.(5)Removed 9.1.7 in Section 9.(6)Updated reference to American Standard for Quality in Section 2.(7)AMS 4998A Powder 6Al-4V Premium Quality (non concurrent) has been cancelled in 2002. AMS 4998C is the current

48、standard. AMS 4998C states a maximum tin and copper content of 0.10 wt %. Subsections 2.4 and X1.4 were updated.(8)The iron content was reinstated to 0.30 wt % max in Table 1.(9)The reference to processing aids was removed in subsection 7.2 and Section 8.(10)Added E29 to subsections 2.1 and 8.1(11)S

49、ection 6, footnote E, Table 1 the words “buyer “ and “seller” were updated to “purchaser” and “supplier”.(12)Subsection 7.2, the words “buyer” and “seller” were updated to “purchaser” and “supplier”.(13)Subsection 10.1, the word “producer” was updated to “supplier”.(14)Subsection X1.9, removed the reference to MPIF standards.(15)Subsection X2.1, removed the reference to F981 and restated.F1580 124(16)Section Appendix X2, the phrase “For CONTROL ALLOYS” was removed.(17)Table 1, yttrium callout of 0.005 wt % inserted for Ti 6Al 4V powder. Yttrium callout inserted in Tabl