【英文标准名称】:Biologicalevaluationofmedicaldevices-Part10:Testsforirritationanddelayed-typehypersensitivity
【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】:ISO10993-10-2002
【标准状态】:作废
【国别】:国际
【发布日期】:2002-09
【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/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:减速度;医疗设备;外科植入物;皮肤接触;生物试验;变应性;医疗产品;生物分析和试验;敏感性测定;敏感;测试;牙科设备;定义;外科设备;牙科学;评定
【英文主题词】:Allergenic;Allergies;Animals;Bioassay;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Chemicals;Classification;Deceleration;Definitions;Dentalequipment;Dentistry;Determinationsofsusceptibility;Evaluations;Eyes;Invitro;Invivo;Information;Instruments;Layout;Mass;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Observation;Planning;Principle;Rabbits;Samples;Selection;Sensitization;Sideeffects;Skin(body);Skincontact;Surgicalequipment;Surgicalimplants;Testanimals;Testperformance;Testing;Trials
【摘要】:ThispartofISO10993describestheprocedurefortheassessmentofmedicaldevicesandtheirconstituentmaterialswithregardtotheirpotentialtoproduceirritationanddelayed-typehypersensitivity.ThispartofISO10993includesa)pretestconsiderations,b)detailsofthetestprocedures,andc)keyfactorsfortheinterpretationoftheresults.InstructionsaregiveninannexAforthepreparationofmaterialsspecificallyinrelationtotheabovetests.Supplementarytestswhicharerequiredspecificallyfordevicesusedintradermallyintheocular,oral,rectal,penileandvaginalareasaregiveninannexB.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:49P;A4
【正文语种】:英语


【英文标准名称】:StandardTestMethodsforDetectingDetrimentalIntermetallicPhaseinDuplexAustenitic/FerriticStainlessSteels
【原文标准名称】:测定双联奥氏体/铁素体不锈钢不稳定金属间相的标准试验方法
【标准号】:ASTMA923-2008
【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】:A01.14
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:成双的;双工
【英文主题词】:duplex;intermetallic;stainlesssteels;Austeniticstainlesssteel;Charpyimpacttest;Detrimentalintermetallicphasedetection;Duplexstainlesssteel;Etchstructures;Ferricchloridecorrosiontest;Ferriticstainlesssteel;Intermetallicphasedet
【摘要】:1.1Thepurposeofthesetestmethodsistoallowdetectionofthepresenceofintermetallicphasesinduplexstainlesssteelstotheextentthattoughnessorcorrosionresistanceisaffectedsignificantly.Thesetestmethodswillnotnecessarilydetectlossesoftoughnessorcorrosionresistanceattributabletoothercauses.1.2Duplex(austenitic-ferritic)stainlesssteelsaresusceptibletotheformationofintermetalliccompoundsduringexposuresinthetemperaturerangefromapproximately600to1750x00B0;F(320to955x00B0;C).Thespeedoftheseprecipitationreactionsisafunctionofcompositionandthermalorthermomechanicalhistoryofeachindividualpiece.Thepresenceofthesephasesisdetrimentaltotoughnessandcorrosionresistance.1.3Correctheattreatmentofduplexstainlesssteelscaneliminatethesedetrimentalphases.Rapidcoolingoftheproductprovidesthemaximumresistancetoformationofdetrimentalphasesbysubsequentthermalexposures.1.4Compliancewiththechemicalandmechanicalrequirementsfortheapplicableproductspecificationdoesnotnecessarilyindicatetheabsenceofdetrimentalphasesintheproduct.1.5Thesetestmethodsincludethefollowing:1.5.1TestMethodA8212;SodiumHydroxideEtchTestforClassificationofEtchStructuresofDuplexStainlessSteels(Sections3-7).1.5.2TestMethodB8212;CharpyImpactTestforClassificationofStructuresofDuplexStainlessSteels(Sections8-13).1.5.3TestMethodC8212;FerricChlorideCorrosionTestforClassificationofStructuresofDuplexStainlessSteels(Sections14-20).1.6Thepresenceofdetrimentalintermetallicphasesisreadilydetectedinallthreetests,providedthatasampleofappropriatelocationandorientationisselected.Becausetheoccurrenceofintermetallicphasesisafunctionoftemperatureandcoolingrate,itisessentialthatthetestsbeappliedtotheregionofthematerialexperiencingtheconditionsmostlikelytopromotetheformationofanintermetallicphase.Inthecaseofcommonheattreatment,thisregionwillbethatwhichcooledmostslowly.Exceptforrapidlycooledmaterial,itmaybenecessarytosamplefromalocationdeterminedtobethemostslowlycooledforthematerialpiecetobecharacterized.1.7Thetestsdonotdeterminetheprecisenatureofthedetrimentalphasebutratherthepresenceorabsenceofanintermetallicphasetotheextentthatitisdetrimentaltothetoughnessandcorrosionresistanceofthematerial.1.8Examplesofthecorrelationofthermalexposures,theoccurrenceofintermetallicphases,andthedegradationoftoughnessandcorrosionresistancearegiveninAppendixX1andAppendixX2.1.9Thevaluesstatedineitherinch-poundorSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.10Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.3.1Thesodiumhydroxideetchtestmaybeusedfortheacceptanceofmaterialbutnotforrejection.Thistestmethodmaybeusedwithotherevaluationteststoprovidearapidmethodforidentifyingthosespecimensthatarefreeofdetrimentalintermetallicphasesasmeasuredintheseothertests.