1、Designation:F222409(Reapproved 2014)Standard Specification forHigh Purity Calcium Sulfate Hemihydrate or Dihydrate forSurgical Implants1This standard is issued under the fixed designation F2224;the number immediately following the designation indicates the year oforiginal adoption or,in the case of
2、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 material requirements for un-fabricated and fabricated forms of hydrated cal
3、cium sulfateintended for surgical implants.Fabricated forms may includepressed and cast surgical implants in various geometric shapes.The calcium sulfate hemihydrate in the unfabricated form canbe converted with the addition of water or other water-containing solutions to a fabricated calcium sulfat
4、e dihydrateform.1.2 The requirements of this specification apply to calciumsulfate combined with two molecules of water or two calciumsulfate molecules sharing one water molecule.Approximate chemical formulae:Calcium Sulfate DihydrateCaSO42H2OCalcium Sulfate HemihydrateCaSO41/2H2O or CaSO4H2OCaSO41.
5、3 This specification specifically excludes calcium sulfateanhydrite and calcium sulfate forms that contain additives suchas reinforcing phases,medicaments,biological agents,and soforth.1.4 The presence of processing aids does not exclude aproduct from the physical and mechanical requirements of this
6、specification.1.5 Some provisions of Specification C59/C59M and TestMethods C472 apply.Special requirements that are detailed inthis specification are included to characterize the materialwhich will be used in surgical implants.1.6 The biological response to calcium sulfate in bone tissuehas been we
7、ll characterized by a history of clinical use(1-14)2and by laboratory studies(15-18).1.7 The following precautionary caveat pertains only to thetest method portion,Sections 4,5,and 6,of this specification.This standard does not purport to address all of the safetyconcerns,if any,associated with its
8、use.It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatoryrequirements prior to use.2.Referenced Documents2.1 ASTM Standards:3C59/C59M Specification for Gypsum Casting Plaster andGypsum Molding PlasterC47
9、2 Test Methods for Physical Testing of Gypsum,Gyp-sum Plasters and Gypsum ConcreteF648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF756 Practice for Assessment of Hemolytic Properties ofMaterialsF763 Practice for Short-Term Screening o
10、f 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
11、 on Muscle and BoneF1088 Specification for Beta-Tricalcium Phosphate for Sur-gical ImplantationF1635 Test Method forin vitro Degradation Testing of Hy-drolytically Degradable Polymer Resins and FabricatedForms for Surgical Implants2.2 Other Documents:BS 6463-102:2001 Quicklime,Hydrated Lime and Natu
12、ralCalcium CarbonatePart 102:Methods for ChemicalAnalysis41This 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 March 1,2014.Published March
13、 2014.Originallyapproved in 2003.Last previous edition approved in 2009 as F2224 09.DOI:10.1520/F2224-09(2014).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 Se
14、rvice at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.4Available from the British Standards Institution,c/o IHS Engineering/IHSInternational,15InvernessWayEast,Englewood,CO80112,http:/.Copyright ASTM International
15、,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 US Pharmacopeia XXIV(USP 24)NF-195CFR Title 21,Part 820 Quality System Requirements6Food Chemical Codex(FCC)7European Pharmacopeia8ISO 10993-1 Biological Evaluation of Medical Devices93.Terminology3.1 Definitions:3.1.1
16、 calcium sulfate anhydritea chemical substance hav-ing approximate molecular formula of CaSO4.3.1.2 calcium sulfate dihydratea chemical having theapproximate molecular formula of CaSO42H2O.This sub-stance is also known as gypsum.3.1.3 calcium sulfate hemihydratea chemical substancehaving approximate molecular formula of CaSO41/2H2O orCaSO4H2OCaSO4.The mineral name of this substance isbassanite and the substance is also known as Plaster of Paris inthe clinical literature.3.1.4 processing aidsany