ASTM F1538-2003(2009) Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation《玻璃和玻璃瓷质植入人体生物材料的标准规范》.pdf

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1、Designation: F 1538 03 (Reapproved 2009)Standard Specification forGlass and Glass Ceramic Biomaterials for Implantation1This standard is issued under the fixed designation F 1538; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、 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. Scope1.1 This specification covers the material requirements andcharacterization techniques for glass and glass-cerami

3、c bioma-terials intended for use as bulk porous or powdered surgicalimplants, or as coatings on surgical devices, but not includingdrug delivery systems.1.2 The biological response to glass and glass-ceramicbiomaterials in bone and soft tissue has been demonstrated inclinical use (1-12)2and laborato

4、ry studies (13-17).1.3 This specification excludes synthetic hydroxylapatite,hydroxylapatite coatings, aluminum oxide ceramics, alpha- andbeta-tricalcium phosphate, and whitlockite.1.4 WarningMercury has been designated by EPA andmany state agencies as a hazardous material that can causecentral nerv

5、ous system, kidney, and liver damage. Mercury, orits vapor, may be hazardous to health and corrosive tomaterials. Caution should be taken when handling mercury andmercury-containing products. See the applicable product Ma-terial Safety Data Sheet (MSDS) for details and EPAs website(http:/www.epa.gov

6、/mercury/faq.htm) for additional informa-tion. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited bystate law.2. Referenced Documents2.1 ASTM Standards:3C 158 Test Methods for Strength of Glass by Flexure(Determination of Modulus of Ru

7、pture)C 169 Test Methods for Chemical Analysis of Soda-Limeand Borosilicate GlassC 373 Test Method for Water Absorption, Bulk Density,Apparent Porosity, and Apparent Specific Gravity of FiredWhiteware ProductsC 623 Test Method for Youngs Modulus, Shear Modulus,and Poissons Ratio for Glass and Glass-

8、Ceramics byResonanceC 633 Test Method for Adhesion or Cohesion Strength ofThermal Spray CoatingsC 693 Test Method for Density of Glass by BuoyancyC 729 Test Method for Density of Glass by the Sink-FloatComparatorC 730 Test Method for Knoop Indentation Hardness ofGlassC 958 Test Method for Particle S

9、ize Distribution of Alu-mina or Quartz by X-Ray Monitoring of Gravity Sedimen-tationC 1069 Test Method for Specific Surface Area of Aluminaor Quartz by Nitrogen AdsorptionC 1070 Test Method for Determining Particle Size Distri-bution of Alumina or Quartz by Laser Light ScatteringE 228 Test Method fo

10、r Linear Thermal Expansion of SolidMaterials With a Push-Rod DilatometerF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.

11、2 Code of Federal Regulations:4Title 21, Part 8202.3 United States Pharmacopoeia:5Lead Mercury Arsenic Heavy Metals Method I1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceram

12、ic Materials.Current edition approved April 1, 2009. Published April 2009. Originallyapproved in 1994. Last previous edition approved in 2003 as F 1538 031.2The boldface numbers in parentheses refer to the list of references at the end ofthis specification.3For referenced ASTM standards, visit the A

13、STM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail

14、 Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.5Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.2.4 U.S. Geological

15、 Survey Method:6Cadmium3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 bioactive glassan amorphous silicate-based solidthat is not intrinsically adhesive and that is capable of forminga cohesive bond with both hard and soft tissue when implanted,and will develop a hydroxycarbo

16、nate apatite layer whenexposed to appropriate in vitro environments, such as simu-lated body fluid or tris-hydroxymethylaminomethane buffer.3.1.2 bioactive glass-ceramican amorphous-derived crys-talline silicate-based solid that is not intrinsically adhesive andthat is capable of forming a cohesive

17、bond with bone and softtissue when implanted, and will develop a hydroxycarbonateapatite layer when exposed to appropriate in vitro environ-ments, such as simulated body fluid or tris-hydroxymethylaminomethane buffer.3.1.3 bulk materialintended to describe a unit materialused as a load bearing impla

18、nt.3.1.4 coatingintended to describe a surface layer that isrelatively thin compared to the overall dimensions of theprosthetic part that has been coated.3.1.5 glass biomaterialany one of a number of composi-tions of amorphous inorganic solids that are used as implantmaterials for various medical or

19、 dental uses, or both.3.1.6 glass-ceramic biomaterialsany one of a number ofcompositions of an amorphous-derived crystalline solid that isused as an implantable biomaterial for medical or dental use, orboth.3.1.7 particulate materialintended to describe severalpieces (usually small size) used togeth

20、er within an implantconstruct.4. Chemical Requirements4.1 Bulk compositions shall be tested using Test MethodC 169.4.2 The concentration of trace element levels in the bioac-tive glass and glass-ceramics shall be limited as follows:Element ppm, maxArsenic (As) 3Cadmium (Cd) 5Mercury (Hg) 5Lead (Pb)

21、30total heavy metals (as lead) 50Either inductively-coupled plasma/mass spectroscopy (ICP/MS) (18), atomic absoprtion (AAS), or the methods listed in2.3 and 2.4 shall be used.5. Physical Characterization5.1 The following physical and mechanical characteriza-tions may be applicable to various bioacti

22、ve glass and glass-ceramics products and should be used whenever possible toverify the material.5.1.1 DensityThe densities of glass and glass ceramicmaterials are related directly to the processing history andcomposition of the material. The density of the bulk materialshall be measured using Test M

23、ethods C 373 or C 729 and shallbe consistent for the specific materials.NOTE 1This test should use a non-aqueous liquid for bioactive glassand glass ceramic materials, which are known to react in an aqueousenvironment and could thereby affect the measurement.5.1.2 Flexural StrengthWhen used as bulk

24、materials inload bearing applications, the flexural strength of the bulkmaterial shall be measured using Test Methods C 158.5.1.3 Youngs ModulusWhen used as a bulk material,Youngs Modulus of glass and glass ceramic biomaterials shallbe determined following Test Method C 623.5.1.4 HardnessWhere appli

25、cable, for characterization ofthe material, the hardness of bulk samples shall be determinedusing Test Method C 730. The Knoop indentation hardness isone of many properties that is used to characterize glasses.Attempts have been made to relate Knoop hardness to tensilestrength, but no generally acce

26、pted methods are available. Suchconversion is limited in scope and should be used with caution,except for special cases in which a reliable basis for conversionhas been obtained by conversion tests.5.1.5 Surface AreaThe surface area of a particulate maybe important in determining the reliability of

27、the bioactivity ofthe material. Whenever the specific surface area of the materialrelates to function, the surface area of particulate glass andglass ceramic biomaterials shall be measured using TestMethod C 1069.5.1.6 Bond Strength of Glass or Glass Ceramic CoatingWhen used as a coating on a metall

28、ic or ceramic substrate, thebond strength of the coating shall be measured following TestMethod C 633.5.1.7 CrystallinityFor glass-ceramic biomaterials, thepercent crystallinity and crystal phases present in glass ceramicbiomaterials shall be determined by means of X-ray diffractionanalysis. While t

29、here is no single standard method for deter-mining the crystallinity and crystal phases of glass ceramicmaterials, techniques such as those detailed in Refs (19) and(20) should be followed to standardize methods as much aspossible.5.1.8 Thermal ExpansionThermal expansion shall bemeasured using Test

30、Method E 228, when materials are to beused for coatings (raw materials are to be measured), or onfinished product as a quality control test.5.1.9 Particle SizeWhen used as a particulate, the particlesize shall be measured in accordance with Test Methods C 958or C 1070.6. Biocompatibility6.1 Glass an

31、d glass-ceramic biomaterials should be evalu-ated thoroughly for biocompatibility before human use. Bio-active glass and glass-ceramic materials are unique in theirmode of action when implanted in the body due to the releasedionic species and the mechanisms by which these materialsbond with bony tis

32、sue. These materials have been found toexhibit an excellent tissue response in laboratory studies(13-17) and clinical usage (1-12). Before any new formulations6Crock, J.G., Felichte, F.E., Briggs, P.H., “Determination of Elements inNational Bureau of Standards Geological Reference Materials SRM 278

33、Obsidianand SRM 688 Basalt by Inductively Coupled Plasma-Atomic Emission Spectrom-etry,” Geostandards Newsletter, Vol 7, 1983, pp. 335340.F 1538 03 (2009)2are used clinically, the tissue response should be characterizedby the methods recommended in Practice F 748 and F 981 asappropriate.7. Test Spec

34、imen Fabrication7.1 Test specimens should be prepared concurrent withimplant devices, as well as from the same batch of material andby the same processes as those used in fabricating the glass andglass-ceramic implant device.8. Quality Program Requirement8.1 The manufacturer shall conform to Quality

35、 Systemsrequirements (2.2) or equivalent.9. Keywords9.1 bioactive glass; bioactive glass-ceramics; glass bioma-terials; glass-ceramic biomaterial; surgical implantsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 A number of glass-ceramic materials are availablecommercially. Bioactive glass and

36、 glass-ceramic materials areavailable commercially as synthetic graft materials for main-tenance of the alveolar ridge; as devices for spinal fusion; asimplants for replacement of the vertebral body, iliac crest, andossicular chain of the middle ear; as bone filler to substitute forbone defects rema

37、ining after the excision of bone tumors andextraction of loosened joint prostheses; and as coatings ondental and orthopedic implants. As with any implant material,the bioresponse is critically dependent on the material proper-ties. To achieve reliable biocompatibility, these properties mustbe known

38、and consistent. This specification provides specifi-cations for biocompatible grades of bioactive glass and glass-ceramics.X1.2 In order to be called bioactive, the materials mustdemonstrate that living tissue is bonding to a significantlyhigher level than non-bonding implant control, as well asdemo

39、nstrate that ionic species are released from the materialinto solution in a controlled and reproducible manner.X1.3 Bioactive glass and glass-ceramic materials are gen-erally silicate-based materials, with additions of oxides ofcalcium, phosphorous, and various alkalis. They may bephosphate-based ma

40、terials as well. These materials may alsoinclude fluoride and other alkaline earth metals. Table X1.1gives a few specific examples of the bioactive glass andglass-ceramic materials produced. Since the compositions ofthese materials may vary greatly from product to product, it isnot possible to speci

41、fy their exact compositions.X1.4 It is recognized that separate performance standardsmay be necessary for each end-use product. Physical andmechanical properties were not specified for this reason. Asource of general test methods for glass and ceramic materialsmay be found in the Annual Book of ASTM

42、 Standards,Vol15.02.TABLE X1.1 Typical Bioactive Glass and Glass-Ceramic Compositions (Compositions in Weight %)45S5 BioglassT 52S4.6 BioglassT S53P4 Bioactive Glass A-W-GC (21)SiO245 52 53.0 34.2P2O56 6 4.0 16.3CaO 24.5 21 20.0 44.9CaF20.5MgO 4.6Na2O 24.5 21 23.0F 1538 03 (2009)3X2. BIOCOMPATIBILIT

43、YX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long-term clinical experience with the compo-sitions referred to in this specification has shown that anacceptable level of biological response can be expected if themate

44、rials are used in appropriate applications.REFERENCES(1) Reck, R., “Tissue Reactions to Glass Ceramics in the Middle Ear,”Clin. Otolaryngol, Vol 6, 1981, pp. 5963.(2) Merwin, G. E., “Review of Bioactive Materials for Otological andMaxillofacialApplications,” Handbook of Bioactive Ceramics, Vol 1,Ed.

45、 T.Yamamuro, L. L. Hench, and J. Wilson, CRC Press, Boca Raton,Florida, 1990, pp. 323328.(3) Douek, E., “Otological Applications of Bioglasst Implants,” Pro-ceedings Fourth International Symposium on Bioceramics in Medi-cine, Ed. W. Bonfield, London, United Kingdom, September 10 and11, 1990.(4) Stan

46、ley, H. R., et al., “Residual Alveolar Ridge Maintenance with aNew Endosseous Implant Material,” J. Pros. Dent., Vol 58, No. 5,November 1987.(5) Nakamura, T., et al., “A New Glass-Ceramic for Bone Replacement:Evaluation of its Bonding to Bond Tissue,” Journal of BiomedicalMaterial Research, Vol 19,

47、1985.(6) Yamamuro, T., et al., “Novel Methods for Clinical Application ofBioactive Ceramics,” Bioceramics: Material Characteristics Versusin Vivo Behavior, Ann. New York Acad. Sci., Vol 523, 1988, pp.107114.(7) Yamamuro, T., “Reconstruction of the Iliac Crest with BioactiveGlass-Ceramic Prosthesis,”

48、 Handbook of Bioactive Ceramics Pros-thesis, Eds. T. Yamamuro, L. L. Hench, and J. Wilson, Vol 1, CRCPress, Boca Raton, FL, 1990, pp. 335342.(8) Yamamuro, T., “Replacement of the Spine with Bioactive Glass-Ceramic Prosthesis,” pp. 343352, idem.(9) Taguchi, T., “A Bioactive Glass Powder-Ammonium Hydr

49、ogenPhosphate Composite for Repairing Bone Defects,” Journal of Appl.Biomater., Vol 1, pp. 217223.(10) Froum, S.J., et al., “Comparison of Bioglasst Synthetic Bone GraftParticles and Open Debridement on the Treatment of Human Peri-odontal Disease,” J. Periodontal., Vol 69, 1998, pp. 698-709.(11) Lovelace, T.B., et al, “Clinical Evaluations of Bioactive Glass in theTreatment of Periodontal Osseous Defects,” J. Periodontal., Vol 69,1998, pp. 1027-1035.(12) Stoor, P., et al., “Bioactive Glass S53P4 in Repair of SeptalPerformations and Its Interaction