【英文标准名称】:StandardPracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevices
【原文标准名称】:材料和装置用一般生物试验方法的选择的标准实施规程
【标准号】:ASTMF748-2006(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2006
【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】:F04.16
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:animaltesting;biocompatibility;invivotesting;laboratorytesting;toxicity;Biocompatibility
【摘要】:Theobjectiveofthispracticeistorecommendsufficientbiologicaltestingtoestablishareasonablelevelofconfidenceconcerningthebiologicalresponsetoamaterialordevice,whileatthesametimeavoidingunnecessarytesting.Thispracticeisintendedtoprovideguidancetothematerialsinvestigatorinselectingtheproperprocedurestobecarriedoutforthescreeningofnewormodifiedmaterials.Becauseeachmaterialandeachimplantsituationinvolvesitsownuniquecircumstances,theserecommendationsshouldbemodifiedasnecessaryanddonotconstitutetheonlytestingthatwillberequiredforamaterialnorshouldtheseguidelinesbeinterpretedasminimumrequirementsforanyparticularsituation.Whileanattempthasbeenmadetoproviderecommendationfordifferentimplantcircumstances,someoftherecommendedtestingmaynotbenecessaryorreasonableforaspecificmaterialorapplication.1.1Thispracticerecommendsgenericbiologicaltestmethodsformaterialsanddevicesaccordingtoend-useapplications.Whilechemicaltestingforextractableadditivesandresidualmonomersorresiduesfromprocessingaidsisnecessaryformostimplantmaterials,suchtestingisnotincludedaspartofthispractice.Thereaderiscautionedthattheareaofmaterialsbiocompatibilitytestingisarapidlyevolvingfield,andimprovedmethodsareevolvingrapidly,sothispracticeisbynecessityonlyaguideline.Athoroughknowledgeofcurrenttechniquesandresearchiscriticaltoacompleteevaluationofnewmaterials.1.2Thesetestprotocolsareintendedtoapplytomaterialsandmedicaldevicesforhumanapplication.Biologicalevaluationofmaterialsanddevices,andrelatedsubjectssuchaspyrogentesting,batchtestingofproductionlots,andsoon,arealsodiscussed.Testsincludethoseperformedonmaterials,endproducts,andextracts.Rationaleandcommentsoncurrentstateoftheartareincludedforalltestproceduresdescribed.1.3Thebiocompatibilityofmaterialsusedinsingleormulticomponentmedicaldevicesforhumanusedependstoalargedegreeontheparticularnatureoftheend-useapplication.Biologicalreactionsthataredetrimentaltothesuccessofamaterialinonedeviceapplicationmayhavelittleornobearingonthesuccessfuluseofthematerialforadifferentapplication.Itis,therefore,notpossibletospecifyasetofbiocompatibilitytestmethodswhichwillbenecessaryandsufficienttoestablishbiocompatibilityforallmaterialsandapplications.1.4Theevaluationoftissueengineeredmedicalproducts(TEMPs)may,insomecases,involvedifferentoradditionaltestingbeyondthosesuggestedfornon-tissue-basedmaterialsanddevices.Whereappropriate,thesedifferencesarediscussedinthispracticeandadditionaltestsdescribed.1.5Theethicaluseofresearchanimalsplacestheobligationontheindividualinvestigatortodeterminethemostefficientmethodsforperformingthenecessarytestingwithoutundueuseofanimals.Whereadequatepriordataexiststosubstantiatecertaintypesofsafetyinformation,theseguidelinesshouldnotbeinterpretedtomeanthattestingshouldbeunnecessarilyrepeated.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A40
【国际标准分类号】:07_080
【页数】:8P.;A4
【正文语种】:英语


【英文标准名称】:Householdandsimilarelectricalappliances-Safety-Part2-5:Particularrequirementsfordishwashers
【原文标准名称】:家用和类似用途电器.安全性.第2-5部分:洗碗机的特殊要求
【标准号】:IEC60335-2-5Edition5.2-2008
【标准状态】:作废
【国别】:国际
【发布日期】:2008-09
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/TC61
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;洗碗机;家用的;耐久性;电器;家用电器;(电网)电源;电气工程;电气安全;设备安全;防火安全;加热;家用设备;家用;铭刻;检验;使用说明书;作标记;机械安全;抗湿;防电击;额定电压;安全;安全工程;安全要求;规范(验收);材料强度;测试
【英文主题词】:Definition;Definitions;Dishwashingmachines;Domestic;Durability;Electricappliances;Electrichouseholdappliances;Electricmains;Electricalappliances;Electricalengineering;Electricalhouseholdappliances;Electricalsafety;Equipmentsafety;Firesafety;Heating;Householdequipment;Householduse;Inscription;Inspection;Instructionsforuse;Marking;Mechanicalsafety;Moistureresistance;Protectionagainstelectricshocks;Ratedvoltage;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Strengthofmaterials;Testing
【摘要】:ThisclauseofPartIisreplacedbythefollowing.ThisInternationalStandarddealswiththesafetyofelectricdishwashersforhouseholdandsimilarpurposesthatareintendedforwashingandrinsingdishes,cutleryandotherutensils,theirratedvoltagebeingnotmorethan250Vforsingle-phaseappliancesand480Vforotherappliances.Appliancesintendedfornormalhouseholdandsimilaruseandthatmayalsobeusedbylaymeninshops,inlightindustryandonfarms,arewithinthescopeofthisstandard.However,iftheapplianceisintendedtobeusedprofessionallyforwashingandrinsingdishesandcutleryandotherutensilsthatareusedforcommercialpurposes,theapplianceisnotconsideredtobeforhouseholdandsimilaruseonly.Asfarasispracticable,thisstandarddealswiththecommonhazardspresentedbyappliancesthatareencounteredbyallpersonsinandaroundthehome.However,ingeneral,itdoesnottakeintoaccount-persons(includingchildren)whose~physical,sensoryormentalcapabilities;or~lackofexperienceandknowledgepreventsthemfromusingtheappliancesafelywithoutsupervisionorinstruction;-childrenplayingwiththeappliance.NOTE101Attentionisdrawntothefactthat-forappliancesintendedtobeusedinvehiclesoronboardshipsoraircraft,additionalrequirementsmaybenecessary;-inmanycountriesadditionalrequirementsarespecifiedbythenationalhealthauthorities,thenationalauthoritiesresponsiblefortheprotectionoflabour,thenationalwatersupplyauthoritiesandsimilarauthorities.NOTE102Thisstandarddoesnotapplyto-commercialelectricdishwashingmachines(IEC60335-2-58);-appliancesintendedforindustrialpurposes;-appliancesintendedtobeusedinlocationswherespecialconditionsprevail,suchasthepresenceofacorrosiveorexplosiveatmosphere(dust,vapourorgas).
【中国标准分类号】:Y68
【国际标准分类号】:13_120;97_040_40
【页数】:38P;A4
【正文语种】:英语