Designation:F1581−08(Reapproved2016)StandardSpecificationforCompositionofAnorganicBoneforSurgicalImplants1ThisstandardisissuedunderthefixeddesignationF1581;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversmaterialrequirementsforan-organicxenogeneicorallogeneicbone(apatite)intendedforsurgicalimplants.Foramaterialtobecalledanorganicordeorganifiedbone,itmustconformtothisspecification(seeAppendixX1).1.2Thebiologicalresponsetoapatiteinsofttissueandbonehasbeencharacterizedbyahistoryofclinicaluseandbylaboratorystudies(1,2,3).2Xenogeneicbone,withorganiccomponentspresent,hasbeenshowntobeantigenicinthehumanhost(4)whereasthesamematerialthathasbeencompletelydeorganifiedhasbeenshowntoelicitnoinflam-matoryorforeignbodyreactionsinhumanclinicaluse(5,6,7).1.3Thisspecificationspecificallyexcludessynthetichydroxylapatite,hydroxylapatitecoatings,ceramicglasses,tribasiccalciumphosphate,whitlockite,andalpha-andbeta-tricalciumphosphate.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Warning—MercuryhasbeendesignatedbyEPAandmanystateagenciesasahazardousmaterialthatcancausecentralnervoussystem,kidney,andliverdamage.Mercury,oritsvapor,maybehazardoustohealthandcorrosivetomaterials.Cautionshouldbetakenwhenhandlingmercuryandmercury-containingproducts.SeetheapplicableproductSafetyDataSheet(DS)fordetailsandEPA’swebsite(http://www.epa.gov/mercury/faq.htm)foradditionalinformation.Usersshouldbeawarethatsellingmercuryormercury-containingproducts,orboth,inyourstatemaybeprohibitedbystatelaw.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,suchashealthconcernsduetothepresenceoftransmissibledisease,associatedwithitsuse.Itistherespon-sibilityoftheuserofthisstandardtoestablishappropriatesafetyan...
