ISO 10993-9-1999 医疗器械的生物学评价第9部分:潜在降解产物的定性与定量总则
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来源:标准资料网
【英文标准名称】:Biologicalevaluationofmedicaldevices-Part9:Frameworkforidentificationandquantificationofpotentialdegradationproducts
【原文标准名称】:医疗器械的生物学评价第9部分:潜在降解产物的定性与定量总则
【标准号】:ISO10993-9-1999
【标准状态】:作废
【国别】:国际
【发布日期】:1999-03
【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】:医疗技术学;生物学;分解产物;变坏;生物化学制品;识别;生物测定;评定;量化;医疗产品;测定;降解
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:ThispartofISO10993providesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.ThispartofISO10993isnotapplicableto:a)viable-tissueengineeredproducts;b)methodologiesforthegenerationofdegradationproductsbymechanicalprocesses.Methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;c)leachablecomponentswhicharenotdegradationproducts.Whereproductstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshallbeconsideredasalternatives.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:8P;A4
【正文语种】:英语
【英文标准名称】:StandardGuideforSelectionofTestMethodstoDetermineRateofFluidPermeationThroughGeomembranesforSpecificApplications
【原文标准名称】:透过特殊用途土工薄膜的流体渗透率测试方法选择的标准指南
【标准号】:ASTMD5886-1995(2006)
【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】:D35.10
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:漫延气体;水库;渗透率;处理;废弃材料;蒸气;可变形薄膜衬垫;透过土工薄膜的液体渗透率;离子传输;有机物蒸气传输;聚合物土工薄膜;水蒸气传输;浸泡;浸出;物障;导则
【英文主题词】:barriers;diffusionofgasesandvapors;flexiblemembraneliners(FMLs);gastransmission;leachate;organicvaportransmission;permeability;polymericgeomembranes;reservoirs;transportofchemicalspecies;transportofions;wastedisposal;
【摘要】:Theprincipalcharacteristicofgeomembranesistheirintrinsicallylowpermeabilitytoabroadrangeofgases,vapors,andliquids,bothassingle-componentfluidsandascomplexmixturesofmanyconstituents.Aslowpermeablematerials,geomembranesarebeingusedinawiderangeofengineeringapplicationsingeotechnical,environmental,andtransportationareasasbarrierstocontrolthemigrationofmobilefluidsandtheirconstituents.Therangeofpotentialpermeantsisbroadandtheserviceconditionscandiffergreatly.Thisguideshowsuserstestmethodsavailablefordeterminingthepermeabilityofgeomembranestovariouspermeants.Thetransmissionofvariousspeciesthroughageomembraneissubjecttomanyfactorsthatmustbeassessedinordertobeabletopredictitseffectivenessforaspecificservice.Permeabilitymeasurementsareaffectedbytestconditions,andmeasurementsmadebyonemethodcannotbetranslatedfromoneapplicationtoanother.Awidevarietyofpermeabilitytestshavebeendevisedtomeasurethepermeabilityofpolymericmaterials;however,onlyalimitednumberoftheseprocedureshavebeenappliedtogeomembranes.Testconditionsandproceduresshouldbeselectedtoreflectactualservicerequirementsascloselyaspossible.Itshouldbenotedthatfieldconditionsmaybedifficulttomodelormaintaininthelaboratory.Thismayimpactapparentperformanceofgeomembranesamples.Thisguidediscussesthemechanismofpermeationofmobilechemicalspeciesthroughgeomembranesandthepermeabilityteststhatarerelevanttovarioustypesofapplicationsandpermeatingspecies.Specifictestsforthepermeabilityofgeomembranestobothsingle-componentfluidsandmulticomponentfluidsthatcontainavarietyofpermeantsaredescribedanddiscussed.1.1Thisguidecoversselectingoneormoreappropriatetestmethodstoassessthepermeabilityofallcandidategeomembranesforaproposedspecificapplicationtovariouspermeants.Thewidelydifferentusesofgeomembranesasbarrierstothetransportandmigrationofdifferentgases,vapors,andliquidsunderdifferentserviceconditionsrequiredeterminationsofpermeabilitybytestmethodsthatrelatetoandsimulatetheservice.Geomembranesarenonporoushomogeneousmaterialsthatarepermeableinvaryingdegreestogases,vapors,andliquidsonamolecularscaleinathree-stepprocess(1)bydissolutioninorabsorptionbythegeomembraneontheupstreamside,(2)diffusionthroughthegeomembrane,and(3)desorptiononthedownstreamsideofthebarrier.1.2Therateoftransmissionofagivenchemicalspecies,whetherasasinglepermeantorinmixtures,isdrivenbyitschemicalpotentialorinpracticaltermsbyitsconcentrationgradientacrossthegeomembrane.Variousmethodstoassessthepermeabilityofgeomembranestosinglecomponentpermeants,suchasindividualgases,vapors,andliquidsarereferencedandbrieflydescribed.1.3Varioustestmethodsforthemeasurementofpermeationandtransmissionthroughgeomembranesofindividualspeciesincomplexmixturessuchaswasteliquidsarediscussed.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:P85;G33
【国际标准分类号】:13_060_30;17_120_01
【页数】:8P.;A4
【正文语种】:
基本信息
| 标准名称： | 高频信号发生器质量分等标准 |
| 英文名称： | High-frequency signal generators-Quality grading standard |
| 中标分类： |
石油 >>
石油综合 >>
技术管理 |
| 发布部门： | 中华人民共和国电子工业部 |
| 发布日期： | 1993-04-27 |
| 实施日期： | 1993-10-01 |
| 首发日期： | 1900-01-01 |
| 作废日期： | 2010-01-20 |
| 提出单位： | 中华人民共和国电子下业部科学技术司 |
| 归口单位： | 电子工业部标准化研究所 |
| 起草单位： | 电子工业部41所，766厂 |
| 出版日期： | 1900-01-01 |
| 页数： | 5页 |
适用范围
本标准规定了高频信号发生器的产品质量分等和质量分等的技术要求。本标准适用于高频信号发生器，是考核高频信号发生器质量等级的依据。本标准必须与第2章中引用的标准一起使用。
前言
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目录
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引用标准
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所属分类： 石油 石油综合 技术管理
