ASTM_F_1581_-_08_2016.pdf

Designation:F158108(Reapproved 2016)Standard Specification forComposition of Anorganic Bone for Surgical Implants1This standard is issued under the fixed designation F1581;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 material requirements for an-organic xenogeneic or allogeneic bone(apatite)intended forsurgical implants.For a material to be called anorganic ordeorganified bone,it must conform to this specification(seeAppendix X1).1.2 The biological response to apatite in soft tissue and bonehas been characterized by a history of clinical use and bylaboratory studies(1,2,3).2Xenogeneic bone,with organiccomponents present,has been shown to be antigenic in thehuman host(4)whereas the same material that has beencompletely deorganified has been shown to elicit no inflam-matory or foreign body reactions in human clinical use(5,6,7).1.3 This specification specifically excludes synthetichydroxylapatite,hydroxylapatite coatings,ceramic glasses,tribasic calcium phosphate,whitlockite,and alpha-and beta-tricalcium phosphate.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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 productSafety Data Sheet(DS)for details and EPAs website(http:/www.epa.gov/mercury/faq.htm)for additional information.Users should be aware that selling mercury or mercury-containing products,or both,in your state may be prohibited bystate law.1.6 This standard does not purport to address all of thesafety concerns,such as health concerns due to the presence oftransmissible disease,associated with its use.It is the respon-sibility of the user of this standard to establish appropriatesafety and health practices and determine the applicability ofregulatory limitations prior to use.(See Appendix X2).2.Referenced Documents2.1 ASTM Standards:3D513 Test Methods for Total and Dissolved Carbon Dioxidein WaterD1688 Test Methods for Copper in WaterD2972 Test Methods for Arsenic in WaterD3557 Test Methods for Cadmium in WaterD3559 Test Methods for Lead in WaterD3919 Practice for Measuring Trace Elements in Water byGraphite Furnace Atomic Absorption SpectrophotometryD4129 Test Method for Total and Organic Carbon in Waterby High Temperature Oxidation and by CoulometricDetectionE1184 Practice for Determination of Elements by GraphiteFurnace Atomic Absorption SpectrometryF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1185 Specification for Composition of Hydroxylapatite forSurgical Implants2.2 Code of Federal Regulations:4Title 21,Part 8202.3 National Formulary:5Tribasic Calcium Phosphate2.4 United States Pharmocopeia:6Identification Tests for Calcium and Phosphate Lead Mercury 1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is under the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved Oct.1,2016.Published October 2016.Originallyapproved in 1995.Last previous edition approved in 2012 as F1581 08(2012).DOI:10.1520/F1581-08R16.2The 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.5National Formulary 25.Available from U.S.Pharmacopeia(USP),12601Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.SucceedingUSP editions may alternatively be referenced.6United States Pharmacopeia 30.Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Succeed-ing USP editions may alternatively be referenced.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Cadmium Arsenic Heavy Metals Method 1Nitrogen Determination 2.5 U.S.Geological Survey Method:7Cadmium3.Terminology3.1 Definitions:3.1.1 allogeneic,adjderived from different individuals ofthe same species.3.1.2 anorganic,adjdenoting tissue(for example,bone)from which the organic material has been totally removed.Also referred to as deorganified,deproteinized or deprotein-ated.3.1.3 apa