ISO/IEC Guide 63-1999 医疗器械安全方面的开发并纳入国际标准指南

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【英文标准名称】:GuidetothedevelopmentandinclusionofsafetyaspectsinInternationalStandardsformedicaldevices
【原文标准名称】:医疗器械安全方面的开发并纳入国际标准指南
【标准号】:ISO/IECGuide63-1999
【标准状态】:现行
【国别】:国际
【发布日期】:1999
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Definition;Definitions;Guidebooks;Internationalstandards;Medicalequipment;Medicalproducts;Safety;Safetyrequirements;Standardization;Standards;Terminology
【摘要】:ThisGuideprovidesanapproachtowritinginternationalstandardsformedicaldevicesthattakesintoaccountthehazardsofmedicaluse,theroleofstandardsinmanagingriskinrelationtothemedicalneedforthedeviceandtheuseofstandardsinmedicaldevicedesign,manufactureandregulation.ThisGuidewillalsohelpthosewhousemedicaldevicestandardstounderstandwhatsuchstandardsareintendedtoaccomplish.Amongsuchusersare:—usersofmedicaldevices;—hospitaladministrators;—personnelinvolvedintheprocurementofmedicaldevices;—regulatoryauthorities;—personsresponsibleforthedesignandconstructionofpatientcarefacilities;—personsresponsiblefortheinstallationandmaintenanceofmedicaldevices;—manufacturersofmedicaldevices;—personswhoassemblesystemsofmedicaldevicesfrommorethanonemanufacturer.ThissectoralGuideisintendedtobereadinconjunctionwithISO/IECGuide51.
【中国标准分类号】:C30
【国际标准分类号】:01_120;11_020;11_040_01
【页数】:8P.;A4
【正文语种】:英语


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【英文标准名称】:Ergonomicsofhuman-systeminteraction.Selectionofphysicalinputdevices
【原文标准名称】:人机交互作用的人类工效学.物理输入装置的选择
【标准号】:BSENISO9241-420-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-08-31
【实施或试行日期】:2011-08-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Characteristics;Computerhardware;Computers;Contactarea;Dataacquisition;Datainput;Dataprocessing;Dataprocessingequipment;Definitions;Design;Ergonomics;Fitnessforpurpose;Flowcharts;Handling;Hardware;Indicatingdevices;Inputdevices;Interactive;Keyboards;Lightpens;Man-machine;Mechanicalproperties;Mouse;Occupationalsafety;Officecomputers;Officeequipment;Officeservices;Officework;Officeworkingplaces;Offices(interiorspaces);Overlay;Recommendation;Selection;Specification(approval);Systems;Testing;Testingpersonnel;Touchscreens;Trainings;Use;Users;Visualdisplayunits;Visualdisplayworkstations;Worksystems;Workplacesafety
【摘要】:ThispartofISO9241providesguidancefortheselectionofinputdevicesforinteractivesystems,basedonergonomicfactors,consideringthelimitationsandcapabilitiesofusersandthespecifictasksandcontextofuse.Itdescribesmethodsforselectingadeviceoracombinationofdevicesforthetaskathand.Itcanalsobeusedforevaluatingtheacceptabilityoftrade-offsundertheexistingconditions.ThetargetusersofthispartofISO9241areuserorganizationsandsystemsintegratorswhotailorsystemsforagivencontextofuse.Itisapplicabletothefollowinginputdevices:keyboards,mice,pucks,joysticks,trackballs,trackpads,tabletsandoverlays,touch-sensitivescreens,styliandlightpens.Itdoesnotspecifydesignrequirementsorgiverecommendationsforthosedevices.NOTE1Theselectionguidancehasbeendevelopedforthesingle-fingeruseoftouchpads.Touchpadsthatallowtheuseofmorefingersdoexist;however,thispartofISO9241doesnotofferanyguidanceontheirselection.NOTE2Theonlyphysicalcomponentofaspeech-recognitionsystemisamicrophone.Withoutproperknowledgeofthecontextofuseitisnotpossibletogiveguidanceforselection.
【中国标准分类号】:A25
【国际标准分类号】:13_180;35_180
【页数】:110P.;A4
【正文语种】:英语


【英文标准名称】:StandardSpecificationforGlassWestergrenTube,Disposable
【原文标准名称】:一次性韦斯特格伦玻璃试管的标准规范
【标准号】:ASTME1046-1985(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:1985
【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】:E41.01
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:disposable;glass;tube;Westergren;Bloodmaterials/applications--specifications;Disposablelaboratoryapparatus--specifications;ESR(erythrocytesedimentationrate);Glasslaboratoryapparatus--specifications;Laboratoryapparatus--specifications;Se
【摘要】:1.1Thisspecificationcoversadisposabletubeusedformeasuringtheerythrocytesedimentationrate,ESR(thesuspensionstabilityofredcellsindiluted,anti-coagulatedhumanblood).1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.
【中国标准分类号】:C44
【国际标准分类号】:
【页数】:2P.;A4
【正文语种】:英语