EN 13867-2009 血液透析和相关治疗用浓缩液(包括修改件A1-2009).英文版本DINEN13867-2009-09

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【英文标准名称】:Concentratesforhaemodialysisandrelatedtherapies(includesAmendmentA1:2009);EnglishversionofDINEN13867:2009-09
【原文标准名称】:血液透析和相关治疗用浓缩液(包括修改件A1-2009).英文版本DINEN13867-2009-09
【标准号】:EN13867-2009
【标准状态】:现行
【国别】:
【发布日期】:2009-09
【实施或试行日期】:2009-09-01
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:血液;浓缩物;用户信息;污染;定义(术语);透析器;血液透析过滤器;血液透析器;血透析;血透析设备;处理;作标记;医疗产品;医疗技术学;产品信息;纯度;质量;规范(验收);测试
【英文主题词】:Blood;Concentrates;Consumerinformation;Contamination;Definitions;Dialyzer;Haemodiafiltration;Haemodialysers;Haemodialysis;Haemodialysisequipment;Handling;Marking;Medicalproducts;Medicaltechnology;Productinformation;Purity;Quality;Specification(approval);Testing
【摘要】:
【中国标准分类号】:C45
【国际标准分类号】:11_040_20;11_120_99
【页数】:16P.;A4
【正文语种】:英语


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【英文标准名称】:Informationprocessing;datatransmission,datacommunication;terms
【原文标准名称】:信息处理.数据传输.数据传播.专业术语
【标准号】:DIN44302Bb.1-1989
【标准状态】:作废
【国别】:德国
【发布日期】:1989-11
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:术语;数据处理;词汇;数据传送;数据通信;技术词汇;英语
【英文主题词】:terminology;englishlanguage;vocabulary;dataprocessing;datacommunication;datatransfer;technicalvocabulary
【摘要】:
【中国标准分类号】:L78
【国际标准分类号】:6983
【页数】:48P;A4
【正文语种】:德语


【英文标准名称】:StandardGuideforConductingtheFrogEmbryoTeratogenesisAssay-Xenopus(FETAX)
【原文标准名称】:进行蛙胚胎畸形发生鉴定非洲蟾蜍属(FETAX)的标准指南
【标准号】:ASTME1439-1998(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】:E47.01
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:生物分析和试验;导则
【英文主题词】:amphibia;developmentaltoxicity;FETAX;screeningtest;short-termchronictest;teratogenicity;Xenopus
【摘要】:FETAXisarapidtestforidentifyingdevelopmentaltoxicants.Datamaybeextrapolatedtootherspeciesincludingmammals.FETAXmightbeusedtoprioritizesamplesforfurthertestswhichusemammals.Validationstudiesusingcompoundswithknownmammalianorhumandevelopmentaltoxicity,orboth,suggestthatthepredictiveaccuracywillexceed85%(2).Whenevaluatingatestmaterialformammaliandevelopmentaltoxicity,FETAXmustbeusedwithandwithoutametabolicactivationsystem(MAS).UseofthisexogenousMASshouldincreasethepredictiveaccuracyoftheassaytoapproximately95%.Theaccuracyratecomparesfavorablywithothercurrentlyavailablex201C;invitroteratogenesisscreeningassaysx201D;(3).Anyassayemployingcells,partsofembryos,orwholeembryosotherthaninvivomammalianembryosisconsideredtobeaninvitroassay.Itisimportanttomeasuredevelopmentaltoxicitybecauseembryomortality,malformation,andgrowthinhibitioncanoftenoccuratconcentrationsfarlessthanthoserequiredtoaffectadultorganisms.Becauseofthesensitivityofembryonicandearlylifestages,FETAXprovidesinformationthatmightbeusefulinestimatingthechronictoxicityofatestmaterialtoaquaticorganisms.ResultsfromFETAXmightbeusefulwhenderivingwaterqualitycriteriaforaquaticorganisms(4).FETAXresultsmightbeusefulforstudyingstructure-activityrelationshipsbetweentestmaterialsandforstudyingbioavailability.1.1Thisguidecoversproceduresforobtaininglaboratorydataconcerningthedevelopmentaltoxicityofatestmaterial.ThetestutilizesembryosoftheSouthAfricanclawedfrog,XenopuslaevisandiscalledFETAX(FrogEmbryoTeratogenesisAssay-Xenopus)().Someoftheseprocedureswillbeusefulforconductingdevelopmentaltoxicitytestswithotherspeciesoffrogsalthoughnumerousmodificationsmightbenecessary.Alistofalternativeanuransispresentedin.1.2Arenewalexposureregimenandthecollectionoftherequiredmortality,malformation,andgrowth-inhibitiondataaredescribed.Specialneedsorcircumstancesmightrequiredifferenttypesofexposureanddataconcerningothereffects.Someofthesemodificationsarelistedinalthoughothermodificationsmightalsobenecessary.Whenevertheseproceduresarealteredorotherspeciesused,theresultsoftestsmightnotbecomparablebetweenmodifiedandunmodifiedprocedures.Anytestthatisconductedusingmodifiedproceduresshouldbereportedashavingdeviatedfromtheguide.1.3Theseproceduresareapplicabletoallchemicalseitherindividuallyorinformulations,commercialproductsormixturesthatcanbemeasuredaccuratelyatthenecessaryconcentrationsinwater.Withappropriatemodificationtheseprocedurescanbeusedtoconducttestsontheeffectsoftemperature,dissolvedoxygen,pH,physicalagents,andonmaterialssuchasaqueouseffluents(seeGuideE1192),surfaceandgroundwaters,leachates,aqueousextractsofwater-insolublematerials,andsolidphasesamples,suchassoilsandsediments,particulatematter,sediment,andwholebulksoilsandsediment.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A40
【国际标准分类号】:
【页数】:16P.;A4
【正文语种】: