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【英文标准名称】:StandardSpecificationforCompositionofAnorganicBoneforSurgicalImplants
【原文标准名称】:外科植入用无机骨料成分标准规范
【标准号】:ASTMF1581-2008e1
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.13
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:allogeneic;anorganic;apatite;bone;hydroxyapatite;hydroxylapatite;implant;xenogeneic;Allogeneic;Anorganicbone;Anorganichydroxylapatite;Hydroxylapatite(HA);Orthopaedicmedicaldevices--specifications;Orthopaedicmedicaldevices(bone)-
【摘要】:1.1Thisspecificationcoversmaterialrequirementsforanorganicxenogeneicorallogeneicbone(apatite)intendedforsurgicalimplants.Foramaterialtobecalledanorganicordeorganifiedbone,itmustconformtothisspecification(seeAppendixX1).1.2Thebiologicalresponsetoapatiteinsofttissueandbonehasbeencharacterizedbyahistoryofclinicaluseandbylaboratorystudies(1,2,3).Xenogeneicbone,withorganiccomponentspresent,hasbeenshowntobeantigenicinthehumanhost(4)whereasthesamematerialthathasbeencompletelydeorganifiedhasbeenshowntoelicitnoinflammatoryorforeignbodyreactionsinhumanclinicaluse(5,6,7).1.3Thisspecificationspecificallyexcludessynthetichydroxylapatite,hydroxylapatitecoatings,ceramicglasses,tribasiccalciumphosphate,whitlockite,andalpha-andbeta-tricalciumphosphate.1.4Warningx2014;MercuryhasbeendesignatedbyEPAandmanystateagenciesasahazardousmaterialthatcancausecentralnervoussystem,kidney,andliverdamage.Mercury,oritsvapor,maybehazardoustohealthandcorrosivetomaterials.Cautionshouldbetakenwhenhandlingmercuryandmercury-containingproducts.SeetheapplicableproductMaterialSafetyDataSheet(MSDS)fordetailsandEPAx2019;swebsite(http://www.epa.gov/mercury/faq.htm)foradditionalinformation.Usersshouldbeawarethatsellingmercuryormercury-containingproducts,orboth,inyourstatemaybeprohibitedbystatelaw.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,suchashealthconcernsduetothepresenceoftransmissibledisease,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.(SeeAppendixX2).
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:4P.;A4
【正文语种】:英语