ASTM F749-1998(2007)e1 兔子皮内注射评定材料抽提物

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【英文标准名称】:StandardPracticeforEvaluatingMaterialExtractsbyIntracutaneousInjectionintheRabbit
【原文标准名称】:兔子皮内注射评定材料抽提物
【标准号】:ASTMF749-1998(2007)e1
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:注射;浸渍物;添加剂;掺和剂;评定;材料;医学科学;兔;医疗设备
【英文主题词】:acutetoxicitytests;biocompatibility;intracutaneousinjection;rabbits;testanimals
【摘要】:Thispracticeistobeusedtohelpassessthebiocompatibilityofmaterialsusedinmedicaldevices.Itisanacutetoxicologicaltestdesignedtodetectthepresenceofinjuriousleachablesubstances.Thispracticemaynotbeappropriateforalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtested,theirpotentialapplications,andtherecommendationscontainedinPracticeF748.Theonlyapplicablelimitationistheextractpreparation.RefertoSections4.3and4.4ofPracticeF619foradescriptionofthislimitation.1.1Thispracticeisanonspecific,acutetoxicitytestusedtohelpdeterminethebiocompatibilityofmaterialsusedinmedicaldevices.1.2TheliquidsinjectedintotherabbitsarethoseobtainedbyPracticeF619wheretheextractionvehiclesaresaline,vegetableoil,orotherliquidssimulatinghumanbodyfluids.1.3Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.
【中国标准分类号】:B41
【国际标准分类号】:11_220
【页数】:3P.;A4
【正文语种】: