ANSI/AAMI/ISO 10993-4-2002 医疗器械的生物评定.第4部分:与血液相互作用的试验的选择

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part4:Selectionoftestsforinteractionswithblood
【原文标准名称】:医疗器械的生物评定.第4部分:与血液相互作用的试验的选择
【标准号】:ANSI/AAMI/ISO10993-4-2002
【标准状态】:现行
【国别】:美国
【发布日期】:2002-10-31
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:AAMI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物试验;血液;分类;定义;定义(术语);牙科设备;牙科器械;牙科学;导则;植入物(外科);相互作用;材料;医疗器材;医疗产品;医学科学;医疗技术学;外科设备;外科植入物;测试
【英文主题词】:Bioassay;Biologicaltests;Blood;Classification;Definition;Definitions;Dentalequipment;Dentalinstruments;Dentistry;Guidelines;Implants(surgical);Interaction;Materials;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Surgicalequipment;Surgicalimplants;Testing
【摘要】:Givesguidancetoagencies,manufacturers,researchlaboratoriesandothersforevaluatingtheinteractionsofmedicaldeviceswithblood.
【中国标准分类号】:C30
【国际标准分类号】:11_100
【页数】:
【正文语种】:英语


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【英文标准名称】:Adhesives-Animalglues-Methodsofsamplingandtesting
【原文标准名称】:粘合剂动物胶取样和试验方法
【标准号】:ISO9665-1998
【标准状态】:现行
【国别】:国际
【发布日期】:1998-09
【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/TC61
【标准类型】:()
【标准水平】:()
【中文主题词】:方法;泡沫材料;凝胶;抽样方法;pH值;测定;灰分测定;测量;动物胶;粘胶物;凝固;尺寸;软化点;材料强度;胶粘剂;试验;材料试验;含水量;脂肪含量;定义;粘度
【英文主题词】:Adhesives;Animalglues;Ashdetermination;Definitions;Determination;Dimensions;Fatcontents;Foams;Gels;Glue;Materialstesting;Measurement;Methods;Moisturecontents;pH;Samplingmethods;Setting;Softeningpoint;Strengthofmaterials;Testing;Viscosity
【摘要】:ThisInternationalStandardspecifiesthemethodstobeusedforsamplingandtestingboneandskingluesintheformofpowder,granules,pearlsorcubes.NOTE1Themethodsmaybeextendedtothetestingofotherformsofanimalgluesbysuitablecalculationoftheequivalentdrygluecontent.TheprecisionofthetestmethodsincludedinthisInternationalStandardisnotknownbecauseinterlaboratorydataarenotavailable.Wheninterlaboratorydataareobtained,precisionstatementswillbeaddedtothecorrespondingtestmethodsatthenextrevision.NOTE2Fordetailsofprecisionstatements,refertoISO5725-1:1994,Accuracy(truenessandprecision)ofmeasurementmethodsandresults—Part1:Generalprinciplesanddefinitions.
【中国标准分类号】:G39
【国际标准分类号】:83_180
【页数】:23P.;A4
【正文语种】:英语


【英文标准名称】:StandardTestMethodforDurabilityofSealantsExposedtoContinuousImmersioninLiquids
【原文标准名称】:连续浸液的密封剂寿命标准试验方法
【标准号】:ASTMC1247-1998(2004)
【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】:C24.30
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:adhesion;liquidimmersion;sealant;waterimmersion
【摘要】:Thistestmethoduseselevatedtemperaturetoacceleratethedegradationofasealantanditsadhesiontoasubstrate.Thistestmethodisanacceleratedmethodandwillonlybeapredictoroflong-termdurabilityiftheactualservicetemperatureissignificantlylowerthantheelevatedtesttemperature.Thistestmethodcanbeusedasanindicatoroflongevitybutdirectcorrelationtoactualusewillbedifficultformanyapplications.Thecorrelationofdatafromthistestmethodtoapplicationswherethesealantjointwillhavewetanddrycycleswillbedifficultsince,withsomesealantsonsomesubstrates,adhesionthatislostduringwetperiodsisregainedduringdryperiods.Thistestmethodisperformedinahotliquidandmaybeconsideredanaccelerationofdeteriorationofthesealantorthesealant’adhesiontoasubstrate.Comparedtohowthesealantwillbeusedinsomeapplications,insomecases,thistestmaybelessseverethantheactualapplication.Thebenefitfromtheuseofthistestmethodwilldependonthecomparisonoftheconditionsofthistesttotheactualconditionsofuse(temperature,duration,natureofsubstrate,compositionoftheliquid).Todeterminetheabilityofasealanttoperforminagivenapplication;modificationofthisprocedurewilloftenberequiredandispermissible,asmutuallyagreeduponbypurchaserandseller.1.1Thistestmethodcoversalaboratoryprocedurethatassistsindeterminingthedurabilityofasealantanditsadhesiontoasubstratewhilecontinuouslyimmersedinaliquid.Thistestmethodteststheinfluenceofaliquidonthesealantanditsadhesiontoasubstrate.Itdoesnottesttheaddedinfluenceofconstantstressfromhydrostaticpressurethatisoftenpresentwithsealantsusedinsubmergedandbelow-gradeapplications,nordoesittesttheaddedinfluenceofstressfromjointmovementwhileimmersed.Thistestmethodalsodoesnot(initsstandardform)testtheaddedinfluenceofacidsorcausticsorothermaterialsthatmaybeintheliquid,inmanyapplications.1.2ThevaluesstatedinSIunitsaretoberegardedasthestandard.Theinch-poundgiveninparenthesesareprovidedforinformationonly.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:Q24
【国际标准分类号】:91_100_50
【页数】:4P.;A4
【正文语种】: