ISO 7405-1997 牙科学用于牙科的医疗器械生物相容性临床前评价牙科材料的试验方法
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【英文标准名称】:Dentistry-Preclinicalevaluationofbiocompatibilityofmedicaldevicesusedindentistry-Testmethodsfordentalmaterials
【原文标准名称】:牙科学用于牙科的医疗器械生物相容性临床前评价牙科材料的试验方法
【标准号】:ISO7405-1997
【标准状态】:作废
【国别】:国际
【发布日期】:1997-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC106
【标准类型】:()
【标准水平】:()
【中文主题词】:生物分解试验;定义;牙科设备;生物测定;牙科器械;牙科学;牙科材料;试验
【英文主题词】:Bioassay;Biological;Biologicalanalysisandtesting;Biologicaltests;Clinicalinvestigations;Compatibility;Compatibilitytests;Definition;Definitions;Dentalequipment;Dentalinstruments;Dentalmaterials;Dentistry;Materials;Medicaldevices;Medicalproducts;Pharmacology;Testing
【摘要】:ThisInternationalStandardspecifiesmethodsfortheevaluationofbiologicaleffectsofdentalmaterials.Itincludestestingofpharmacologicalagentsthatareanintegralpartofthedeviceundertest.
【中国标准分类号】:C33
【国际标准分类号】:11_060_10
【页数】:18P;A4
【正文语种】:英语
【英文标准名称】:StandardTestMethodforEvaluationofAntimicrobialFormulationsbytheAgarPatchTechnique
【原文标准名称】:用琼脂斑贴技术评价抗菌剂的标准试验方法
【标准号】:ASTME1882-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:E35.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:活性;琼脂;控制;洗涤剂;效率;微生物;试验方法;瞬时的
【英文主题词】:agarpatch;antibacterial;controlformulation;residentmicroorganism;persistentactivity;transientmicroorganism
【摘要】:Thisprocedurecanbeusedtoevaluateformulationscontainingingredientsintendedtoinhibitgrowthofbacteriaonintactskinandmeasuresthedifference,post-product-exposure,betweennumbersofbacterialcoloniesonactivetestformulationplatesandnumbersoncontrolplates,expressedaspercentinhibition.Thisproceduremayalsobeusedtotestforpersistenceofactivity,asafunctionoftimeelapsedbetweenapplicationofactivetestformulationandapplicationofactivetestplates.Becausenoprocedureforneutralizationoftheantimicrobialactionofactiveingredientscanbeincludedinthetest,theagarpatchmethodislimitedtotheextentthatresultsexpressedaspercentinhibitiondonotdifferentiatebetweenbacteriostaticandbacteriocidaleffectsand,hence,mustnotbeportrayedasx201C;reductions.x201D;1.1Thistestmethoddeterminestheantibacterialactivityandpersistenceoftestformulations,asmeasuredbytheinhibitionofatestorganismonanagarsurfaceexposedtotestsitesonhumanskintreatedwiththeformulations.1.2Aknowledgeofmicrobiologicaltechniquesisrequiredfortheseprocedures.1.3ItistheresponsibilityoftheinvestigatortodetermineifGoodLaboratoryPractice(GLP)andGoodClinicalPractice(GCP)arerequiredandtoadheretothesepractices,asappropriate.1.4Inthistestmethod,metricunitsareusedforallapplicationsexceptlinearmeasure.Inthatcase,inchesareusedandmetricunitsfollowinparentheses.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Performanceofthisprocedurerequirestheknowledgeofregulationspertainingtotheprotectionofhumansubjects(see21CFR,Ch.I,Parts50and56).
【中国标准分类号】:Y40
【国际标准分类号】:71_100_40
【页数】:4P.;A4
【正文语种】:
【英文标准名称】:StandardPracticeforEvaluationofImmuneResponsesInBiocompatibilityTestingUsingELISATests,Lymphocyte,Proliferation,andCellMigration
【原文标准名称】:用酶标记免疫分析试验、淋巴细胞扩散和细胞移动评价生物配伍中免疫反应的标准操作规程
【标准号】:ASTMF1906-1998(2003)
【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】:生物配伍;细胞移动;抗原辅体;免疫反应;淋巴细胞扩散;酶标记免疫分析
【英文主题词】:biocompatibility;cellmigration;ELISA;haptens;immuneresponse;lymphocyteproliferation
【摘要】:1.1Thispracticecoverstheintroductionofaforeignsubstanceintomammalianbodythatmayinducetheformationofanimmuneresponse.Theimmuneresponsemayleadtoinadvertenttissuedamageandbeanundesirableevent.Inthestandardprotocolsf
【中国标准分类号】:C04
【国际标准分类号】:11_020
【页数】:5P.;A4
【正文语种】:
