ASTM_F_1538_-_03_2009.pdf

Designation:F153803(Reapproved 2009)Standard Specification forGlass and Glass Ceramic Biomaterials for Implantation1This standard is issued under the fixed designation F1538;the number immediately following the designation indicates the year oforiginal adoption 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.Scope1.1 This specification covers the material requirements andcharacterization techniques for glass and glass-ceramic 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 laboratory 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 nervous 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/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:3C158 Test Methods for Strength of Glass by Flexure(De-termination of Modulus of Rupture)C169 Test Methods for Chemical Analysis of Soda-Limeand Borosilicate GlassC373 Test Method for Water Absorption,Bulk Density,Apparent Porosity,andApparent Specific Gravity of FiredWhiteware ProductsC623 Test Method for Youngs Modulus,Shear Modulus,and Poissons Ratio for Glass and Glass-Ceramics byResonanceC633 Test Method for Adhesion or Cohesion Strength ofThermal Spray CoatingsC693 Test Method for Density of Glass by BuoyancyC729 Test Method for Density of Glass by the Sink-FloatComparatorC730 Test Method for Knoop Indentation Hardness of GlassC958 Test Method for Particle Size Distribution of Aluminaor Quartz by X-Ray Monitoring of Gravity SedimentationC1069 Test Method for Specific Surface Area of Alumina orQuartz by Nitrogen AdsorptionC1070 Test Method for Determining Particle Size Distribu-tion of Alumina or Quartz by Laser Light ScatteringE228 Test Method for Linear Thermal Expansion of SolidMaterials With a Push-Rod DilatometerF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 Code of Federal Regulations:4Title 21,Part 8202.3 United States Pharmacopoeia:5Lead Mercury Arsenic Heavy Metals Method I2.4 U.S.Geological Survey Method:6Cadmium3.Terminology3.1 Definitions of Terms Specific to This Standard:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved April 1,2009.Published April 2009.Originallyapproved in 1994.Last previous edition approved in 2003 as F1538 031.DOI:10.1520/F1538-03R09.2The boldface numbers in parentheses refer to the list of references at the end ofthis specification.3For referenced ASTM standards,visit the ASTM 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 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.6Crock,J.G.,Felichte,F.E.,Briggs,P.H.,“Determination of Elements inNational Bureau of Standards Geological Reference Materials SRM 278 Obsidianand SRM 688 Basalt by Inductively Coupled Plasma-Atomic EmissionSpectrometry,”Geostandards Newsletter,Vol 7,1983,pp.335340.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 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 hydroxycarbonate 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 cohesiv