ASTM F756-2008 材料溶血性能评估的标准实施规程
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【英文标准名称】:StandardPracticeforAssessmentofHemolyticPropertiesofMaterials
【原文标准名称】:材料溶血性能评估的标准实施规程
【标准号】:ASTMF756-2008
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;bloodcompatibility;directcontact;extract;hemoglobin;hemolysistesting;Biocompatibility;Bloodmaterials/applications;Hemolysisassessment;Plasmahemoglobin;Rabbits
【摘要】:Thepresenceofhemolyticmaterialincontactwiththebloodmaycauselossof,ordamageto,redbloodcellsandmayproduceincreasedlevelsoffreeplasmahemoglobincapableofinducingtoxiceffectsorothereffectswhichmaystressthekidneysorotherorgans.Thispracticemaynotbepredictiveofeventsoccurringduringalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtested,theirpotentialapplications,andtherecommendationscontainedinPracticeF748.1.1Thispracticeprovidesaprotocolfortheassessmentofhemolyticpropertiesofmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitrohemolyticpropertiesofmaterialsintendedforuseincontactwithblood.1.3Thispracticeconsistsofaprotocolforahemolysistestunderstaticconditionswitheitheranextractofthematerialordirectcontactofthematerialwithblood.Itisrecommendedthatbothtests(extractanddirectcontact)beperformedunlessthematerialapplicationorcontacttimejustifiestheexclusionofoneofthetests.1.4Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:11_100
【页数】:5P.;A4
【正文语种】:英语
【原文标准名称】:材料溶血性能评估的标准实施规程
【标准号】:ASTMF756-2008
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:biocompatibility;bloodcompatibility;directcontact;extract;hemoglobin;hemolysistesting;Biocompatibility;Bloodmaterials/applications;Hemolysisassessment;Plasmahemoglobin;Rabbits
【摘要】:Thepresenceofhemolyticmaterialincontactwiththebloodmaycauselossof,ordamageto,redbloodcellsandmayproduceincreasedlevelsoffreeplasmahemoglobincapableofinducingtoxiceffectsorothereffectswhichmaystressthekidneysorotherorgans.Thispracticemaynotbepredictiveofeventsoccurringduringalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtested,theirpotentialapplications,andtherecommendationscontainedinPracticeF748.1.1Thispracticeprovidesaprotocolfortheassessmentofhemolyticpropertiesofmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitrohemolyticpropertiesofmaterialsintendedforuseincontactwithblood.1.3Thispracticeconsistsofaprotocolforahemolysistestunderstaticconditionswitheitheranextractofthematerialordirectcontactofthematerialwithblood.Itisrecommendedthatbothtests(extractanddirectcontact)beperformedunlessthematerialapplicationorcontacttimejustifiestheexclusionofoneofthetests.1.4Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:11_100
【页数】:5P.;A4
【正文语种】:英语
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