ISO 10993-10-2010 医疗器械的生物评定.第10部分:刺激与持续型过敏症试验
时间:2024-05-05 12:20:07 来源: 标准资料网 作者：标准资料网 阅读：8090
【英文标准名称】:Biologicalevaluationofmedicaldevices.Part10:Testsforirritationandskinsensitization
【原文标准名称】:医疗器械的生物评定.第10部分:刺激与持续型过敏症试验
【标准号】:ISO10993-10-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-08-01
【实施或试行日期】:2010-08-01
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:过敏性反应;动物;生物测定;生物的;生物分析和试验;生物危害;生物试验;化学试剂;分类;减速度;定义(术语);牙科设备;牙科学;敏感性测定;评定;眼睛;在体外;在体内;材料;医疗器械;医疗器材;医疗产品;方法;观察;计划;兔;样品;选择;致敏性;副作用;皮肤(身体);皮肤接触;外科设备;外科植入物;试验动物;试验性能;测试;试验
【英文主题词】:Allergies;Animals;Bioassay;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Chemicals;Classification;Deceleration;Definitions;Dentalequipment;Dentistry;Determinationsofsusceptibility;Evaluations;Eyes;Invitro;Invivo;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Observation;Planning;Rabbits;Samples;Selection;Sensitization;Sideeffects;Skin(body);Skincontact;Surgicalequipment;Surgicalimplants;Testanimals;Testperformance;Testing;Trials
【摘要】:ThispartofISO10993describestheprocedurefortheassessmentofmedicaldevicesandtheirconstituentmaterialswithregardtotheirpotentialtoproduceirritationandskinsensitization.ThispartofISO10993includes:a)pretestconsiderationsforirritation,includinginsilicoandinvitromethodsfordermalexposure;b)detailsofinvivo(irritationandsensitization)testprocedures;c)keyfactorsfortheinterpretationoftheresults.InstructionsaregiveninAnnexAforthepreparationofmaterialsspecificallyinrelationtotheabovetests.InAnnexBseveralspecialirritationtestsaredescribedforapplicationofmedicaldevicesinareasotherthanskin.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:74P.;A4
【正文语种】:英语
【英文标准名称】:StandardSpecificationforLaboratoryGlassFilterFlasks
【原文标准名称】:实验室玻璃吸滤瓶
【标准号】:ASTME1406-1995(2005)
【标准状态】:现行
【国别】:
【发布日期】:1995
【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】:E41.01
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:玻璃;实验室器皿
【英文主题词】:flasks;filtering;glass;laboratory
【摘要】:1.1Thisspecificationprovidesstandarddimensionalrequirementsforglassfilteringflaskssuitableforgenerallaboratoryuse.
【中国标准分类号】:N64
【国际标准分类号】:71_040_20
【页数】:4P.;A4
【正文语种】:
【英文标准名称】:Steeltubesandfittingsforonshoreandoffshorepipelines-Externalliquidappliedepoxyandepoxy-modifiedcoatings
【原文标准名称】:岸上和近海管道用钢管和配件.外用液体涂刷的环氧涂料及环氧改性的涂料
【标准号】:BSEN10289-2002
【标准状态】:现行
【国别】:英国
【发布日期】:2002-08-30
【实施或试行日期】:2002-08-30
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:覆层;管;作标记;钢;聚氨酯;试验;钢管;热固性聚合物;海面的;规范(验收);质量保证;配件;输水管道;护壳;检验;塑料;储存;模制件;环氧树脂涂层;管道;外覆层;防腐蚀;环氧树脂;塑料涂层;环氧衍生物;管道覆层;定义;定义
【英文主题词】:Adhesivestrength;Coatings;Composition;Corrosionprotection;Definition;Definitions;Epoxides;Epoxycoatings;Epoxyresins;Exteriorcoatings;Fittings;Gastechnology;Heatageingtests;Inspection;Marking;Mouldedparts;Offshore;Orderindications;Pipecoatings;Pipelines;Pipes;Plasticcoatings;Plastics;Polyurethane;Properties;Qualityassurance;Seamlesspipes;Sheathings;Shockresistance;Specification(approval);Steelpipes;Steels;Storage;Technicaldatasheets;Testing;Thermosettingpolymers;Waterpipelines
【摘要】:ThisEuropeanStandardspecifiesthereqiurementsofliquidappliedexternalcoating,epoxy(EP)andepoxy-modified(EP-MOD),forthecorrosionprotectionofsteeltubesandpipelinefittings.Thecoatinginthisstandardcanbeappliedtolongitudinallyorspirallyweldedandtoseamlesssteeltubesandfittingsusedfortheconstructionofpipelinesforconveyingliquidsorgases.Ifthecomponenthastobecoldbentthecoatingshallbeappliedafterbendingunlessotherwiseapprovedbythepurchaser.Thecoatingshallconsistnormallyofonelayerofliquidproduct,appliedbybrushorbysprayairlesstechnique.Otherapplicationmethodscanberecommendedbytheproductmanufacturer,inaccordancewiththekindofproduct.ThiscoatingcanbeusedfortheprotectionofburiedorsubmergedsteeltubesforserviceatthefollowingtemperaturesandwiththreethicknessclassesA(400μm),B(800μm)andC(1500μm)basedonthefollowingcombination:—type1:-20℃to40℃,thicknessclassAorBorC—type2:-20℃to60℃,thicknessclassBorC—type3:-20℃to80℃,thicknessclassCOthertemperaturescanbeagreed;inthiscase,testsshallbecarriedoutattherequiredtemperature.Inthisstandardthewordcomponentsisusedfortubesandfittings.Frequenciesoftestsonfittingsshallbeagreedbythepartiesattheorderingstage.Componentscoatedwiththesetypesofcoatingsmaybefurtherprotectedbymeansofcathodicprotection.
【中国标准分类号】:H48
【国际标准分类号】:23_040_99;25_220_60
【页数】:44P.;A4
【正文语种】:英语