BS EN ISO 10993-2-1998 医疗器械的生物评定.动物保护要求
时间:2024-04-27 22:26:26 来源: 标准资料网 作者：标准资料网 阅读：8752
【英文标准名称】:Biologicalevaluationofmedicaldevices-Animalwelfarerequirements
【原文标准名称】:医疗器械的生物评定.动物保护要求
【标准号】:BSENISO10993-2-1998
【标准状态】:作废
【国别】:英国
【发布日期】:1998-04-15
【实施或试行日期】:1998-04-15
【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】:实验室试验;外科学;文献索引;试验条件;动物;医疗设备;计划;生物分析和试验;实验室职工;实验室技术;人员;试样
【英文主题词】:Animalprotection;Bioassay;Definition;Definitions;Finemechanics;Implants(surgical);Laboratoryanimals;Medicalequipment;Medicalsciences;Specification(approval);Surgicalequipment;Surgicalimplants
【摘要】:ThispartofISO10993specifiesminimumrequire-mentsfortheuseofanimalsinbiologicaltesting.ThispartofISO10993isalsointendeda)toestablishguidelineswhichallowthescientisttorespectlifeingeneral;b)toreducethenumberofanimalexperimentsandthenumberofanimalsusedinexperiments,amongotherwaysbyoptimizationofthoseper-formed;c)tominimizesufferingandmaintainthequalityoflifeoftheanimalsusedintheexperiments.ThispartofISO10993appliestotheexperimentationperformedonvertebrates.Itdoesnotapplytoexper-imentationperformedonlessdifferentiatedanimals;nordoesitapplytothatpartoftheexperimentalworkperformedonisolatedtissuesandorgans.ThispartofISO10993alsomakesrecommendationsconcernedwiththeaimofreducingthenumberofanimalsusedforbiocompatibilitytestingandwhenpossibleabolishinganimalexperimentsinthisarea.
【中国标准分类号】:C04
【国际标准分类号】:11_040_01;11_060_01;11_100_20;11_120_01
【页数】:16P;A4
【正文语种】:英语
【英文标准名称】:StandardTestMethodforMedandKempFibersinWoolandOtherAnimalFibersbyMicroprojection
【原文标准名称】:用显微投影法测定羊毛和其它动物纤维中的有髓纤维和死毛纤维的标准试验方法
【标准号】:ASTMD2968-1995(2008)
【标准状态】:现行
【国别】:美国
【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】:D13.13
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:animalfibers(exceptwool);microscopicalexamination;wool;Animalfibers;Kempfibercontent;Med(medullated)fibercontent;Microprojection;Woolandwooltop
【摘要】:TestMethodD2968forthedeterminationofmedandkempfibersbymicroprojectionmaybeusedfortheacceptancetestingofcommercialshipmentsofwoolandotheranimalfibers,butcautionisadvisedsinceonlyafewtypesofanimalfibershavebeensubjectedtointerlaboratoryteststoascertaintheprecisionoftestsformedandkempfibersbythistestmethod.Comparativetestsasdirectedin5.1.1maybeadvisable.IncaseofadisputearisingfromdifferencesinreportedtestresultswhenusingTestMethodD2968foracceptancetestingofcommercialshipments,thepurchaserandthesuppliershouldconductcomparativeteststodetermineifthereisastatisticalbiasbetweentheirlaboratories.Competentstatisticalassistanceisrecommendedfortheinvestigationofbias.Asaminimum,thetwopartiesshouldtakeagroupoftestspecimenswhichareashomogeneousaspossibleandwhicharefromalotofmaterialofthetypeinquestion.Thetestspecimensshouldthenberandomlyassignedinequalnumberstoeachlaboratoryfortesting.TheaverageresultsfromthetwolaboratoriesshouldbecomparedusingStudent''st-testforunpaireddataandanacceptableprobabilitylevelchosenbythetwopartiesbeforetestingisbegun.Ifabiasisfound,eitheritscausemustbefoundandcorrected,orthepurchaserandthesuppliermustagreetointerpretfuturetestresultsinviewoftheknownbias.Knowledgeoftheincidenceofmedfibersandkempfibersinwoolandotheranimalfibersisofimportancetomanufacturersofwovenorknittedfabricsbecauseoftheapparentdyeresistanceandlightreflectancequalitiesofthesefibers.Thisisnottoimplythatallkempfiberswillresistdyeandallmedfiberswillacceptdyenormally.Inpractice,aproportionofkempfiberswillappearnormalafterdyeingandaproportionofmedfiberswillappearchalkywhiteafterdyeing.Fromtheperspectiveofvisualandaestheticproblems,medullatedfibershavinganabnormallylargediameterandahighdegreeofmedullationareprobablytheworstkind.Note8212;Thecontrastbetweenthesolidandthehollowportionsofthemedullatedfibersissignificantlyreducedwhenthemedullabecomesfilledwithmountingmedium.FIG.1TypesofMedullainWoolandMohairFibers1.1Thistestmethodcoversthedeterminationbymicroprojectionofthepercentageofmedullatedfibers(medandkempfibers)inwoolorotheranimalfiberssuchasmohair,cashmere,alpaca,orcamel''shairintheirvariousforms.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:W20
【国际标准分类号】:59_060_10
【页数】:3P.;A4
【正文语种】:英语
【英文标准名称】:Protectiveclothing-Protectionagainstliquidchemicals-Performancerequirementsforchemicalprotectiveclothingwithliquid-tightconnectionsbetweendifferentpartsoftheclothing(Type3equipment);GermanversionEN466:1995
【原文标准名称】:化学防护服.防护液态化学药品腐蚀(包括液态气溶胶).性能要求.3型设备.各部分连接接缝不透水的化学防护服
【标准号】:DINEN466-1995
【标准状态】:作废
【国别】:德国
【发布日期】:1995-05
【实施或试行日期】:1995-05-01
【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】:工作场所安全;规范(批准);作标记;防护服装;气溶胶;职业安全;密封;药液;化工防护套服;液体;防护手套;材料强度;防护鞋靴;安全工程;水密
【英文主题词】:safetyengineering;specification(approval);occupationalsafety;chemicals;marking;tightness;protectivegloves;strengthofmaterials;workplacesafety;liquids;protectiveclothing;watertightness;chemical
【摘要】:
【中国标准分类号】:C73
【国际标准分类号】:13_340_10
【页数】:6P;A4
【正文语种】:德语