ASTM_F_451_-_08.pdf

Designation:F45108Standard Specification forAcrylic Bone Cement1This standard is issued under the fixed designation F451;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers self-curing resins used primar-ily for the fixation of internal orthopedic prostheses.Themixture may be used in either the predough or dough stage inaccordance with the manufacturers recommendations.1.2 Units of premeasured powder and liquid are supplied ina form suitable for mixing.The mixture then sets in place.1.3 While a variety of copolymers and comonomers may beincorporated,the composition of the set cement shall containpoly(methacrylic acid esters)as its main ingredient.1.4 This specification covers compositional,physicalperformance,and biocompatibility as well as packaging re-quirements.The biocompatibility of acrylic bone cement as ithas been traditionally formulated and used has been reported inthe literature(1,2).21.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD3835 Test Method for Determination of Properties ofPolymeric Materials by Means of a Capillary RheometerD1193 Specification for Reagent WaterF619 Practice for Extraction of Medical PlasticsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF749 Practice for Evaluating Material Extracts by Intracuta-neous Injection in the RabbitF756 Practice for Assessment of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening of Implant Materi-alsF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF895 Test Method forAgar Diffusion Cell Culture Screeningfor CytotoxicityF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone2.2 ANSI/ADA Standard:No.15 Specification for Acrylic Resin Teeth43.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 doughing timethe time after commencement of mix-ing at which the mixture ceases to adhere to a standard probe(see 7.5).3.1.2 exothermic or maximum temperaturethe maximumtemperature of the mixture due to self-curing in a standardmold(see 7.6).3.1.3 extrusionthe rate of flow of the material through astandard orifice under load(see 7.8.1).3.1.4 intrusionthe distance of flow of the mixture into astandard mold under load(see 7.8.3).3.1.5 setting timethe time after commencement of mixingat which the temperature of the curing mass equals the averageof the maximum and ambient temperatures(see 7.7).3.1.6 unitone package or vial of premeasured powdercomponent and one package or vial of premeasured liquidcomponent.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Aug.1,2008.Published September 2008.Originallyapproved in 1976.Last previous edition approved in 2007 as F451 99a(2007)1.DOI:10.1520/F0451-08.2The boldface numbers in parentheses refer to the list of references at the end ofthis standard.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 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Physical Requirements4.1 Liquid:4.1.1 AppearanceThe liquid shall be free of extraneousparticulate matter or obvious visual contaminants in its con-tainer.4.1.2 StabilityAfter being heated for 48 h at 60 6 2C,theviscosity of the liquid shall not increase by more than 10%ofits original value(see 7.3).4.1.3 SterilityThe liquid,as poured from its container,shall pass the tests described in“Sterility TestsLiquid andOintments”(7.4)(3).4.2 Powder:4.2.1 AppearanceThe powder shall be pourable and freeof extraneous materials,such as dirt or lint(7.2.2).4.2.2 SterilityThe powder,as poured from its package,shall pass the tests described in“Sterility TestsSolids”(7.4)(2).4.3 Powder-Liquid Mixture:4.3.1 If