【英文标准名称】:StandardPracticeforAssessmentofHemolyticPropertiesofMaterials
【原文标准名称】:材料的溶血特性评定的标准规程
【标准号】:ASTMF756-2000
【标准状态】:现行
【国别】:
【发布日期】:2000
【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】:测定;材料;医疗设备;医学科学;特性
【英文主题词】:biocompatibility;bloodcompatibility;directcontact;extract;hemoglobin;hemolysistesting
【摘要】:Thepresenceofhemolyticmaterialincontactwiththebloodmaycauselossof,ordamageto,redbloodcellsandmayproduceincreasedlevelsoffreeplasmahemoglobincapableofinducingtoxiceffectsorothereffectswhichmaystressthekidneysorotherorgans.Thispracticemaynotbepredictiveofeventsoccurringduringalltypesofimplantapplications.Theuseriscautionedtoconsidertheappropriatenessofthemethodinviewofthematerialsbeingtested,theirpotentialapplications,andtherecommendationscontainedinPracticeF748.1.1Thispracticeprovidesaprotocolfortheassessmentofhemolyticpropertiesofmaterialsusedinthefabricationofmedicaldevicesthatwillcontactblood.1.2Thispracticeisintendedtoevaluatetheacuteinvitrohemolyticpropertiesofmaterialsintendedforuseincontactwithblood.1.3Thispracticeconsistsofaprotocolforahemolysistestunderstaticconditionswitheitheranextractofthematerialordirectcontactofthematerialwithblood.1.4Thispracticeisoneofseveraldevelopedfortheassessmentofthebiocompatibilityofmaterials.PracticeF748mayprovideguidancefortheselectionofappropriatemethodsfortestingmaterialsforaspecificapplication.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.1.6Identificationofasupplierofmaterialsorreagentsisfortheconvenienceoftheuseranddoesnotimplysinglesource.Appropriatematerialsandreagentsmaybeobtainedfrommanycommercialsupplyhouses.
【中国标准分类号】:C04
【国际标准分类号】:11_100
【页数】:5P.;A4
【正文语种】: