ASTM E1029-2001 临床实验室计算机系统文献工作的标准指南
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【英文标准名称】:StandardGuideforDocumentationofClinicalLaboratoryComputerSystems
【原文标准名称】:临床实验室计算机系统文献工作的标准指南
【标准号】:ASTME1029-2001
【标准状态】:作废
【国别】:
【发布日期】:2001-01-01
【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】:E31.13
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:数据处理;实验室装备
【英文主题词】:clinicallaboratories;computerizedsystems-clinicallaboratory;documentationofclinicallaboratorycomputersystems,guide;documentation;clinicallaboratorycomputersystems,guide
【摘要】:1.1Thisguidecoversdocumentationforacomputersystemoperatinginaclinicallaboratory.1.2Documentationisdefinedastheinformationneededtoinstall,use,maintain,ormodifythesystem.Thisinformationshallbeinareusableform,andmayexistinotherformsaswell.Theseformsmayincludeprintedmanuals,onlinehelpscreens,prompts,computerreadabletext,computerassistedinstruction,audiotapes,orequivalentmedia.Astechnologyandsoftwaretechniqueschange,theformofthedocumentationmayalsochange.Itisacentralcomponentoftheprocessesbywhichsystemlifecyclesaremanaged.Hereafter,theterm"documentation"shallencompassallsuchpossibleforms.1.2.1Thisdocumentationincludesinformationthatexplainshowtheusersinteractwithandoperatethesystem.Thismayincludeaterminaloperator''sguide,trainingdocumentation,systemoperationdescriptions,anddatabaseandfilemaintenanceinstructions.1.2.2Documentationalsoincludesreferencedocumentsthatdescribefunctionalandinternalcharacteristicsofthesystem,suchassoftwarereferencemanuals,sourcecode,descriptionsoffilestructures,hardwarereferencemanuals,schematics,andflowcharts.Paragraphsandmightapplywhensomeofthisinformationisproprietary.1.2.3Documentationincludestestprocedurestoestablishwhetherthesystemisinstalledcorrectlyandcontinuestooperateproperly.Thefrequencythatthetestsaretobeperformed,thetestdatasetstobeused,andwhethertheresultsaretobecomparedtomanualmethodsshouldbeprovided.1.3Thecomputersystemsunderconsiderationarethosedesignedtoassistthegeneralworkflowofthelaboratory.Theytypicallyincludesomeorallofthefollowingfeatures:sampletracking,datagathering,reportgeneration,recordkeeping,qualityassurance,managementaids,andhospitalcommunications.Theymayrangefromverylargetosmallcomputersystems.Computersdedicatedonlytoasingleinstrumentarenottheprimaryfocus.1.4Thisstandarddoesnotpurporttoaddressthesafetyproblemsassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:8P.;A4
【正文语种】:
【原文标准名称】:临床实验室计算机系统文献工作的标准指南
【标准号】:ASTME1029-2001
【标准状态】:作废
【国别】:
【发布日期】:2001-01-01
【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】:E31.13
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:数据处理;实验室装备
【英文主题词】:clinicallaboratories;computerizedsystems-clinicallaboratory;documentationofclinicallaboratorycomputersystems,guide;documentation;clinicallaboratorycomputersystems,guide
【摘要】:1.1Thisguidecoversdocumentationforacomputersystemoperatinginaclinicallaboratory.1.2Documentationisdefinedastheinformationneededtoinstall,use,maintain,ormodifythesystem.Thisinformationshallbeinareusableform,andmayexistinotherformsaswell.Theseformsmayincludeprintedmanuals,onlinehelpscreens,prompts,computerreadabletext,computerassistedinstruction,audiotapes,orequivalentmedia.Astechnologyandsoftwaretechniqueschange,theformofthedocumentationmayalsochange.Itisacentralcomponentoftheprocessesbywhichsystemlifecyclesaremanaged.Hereafter,theterm"documentation"shallencompassallsuchpossibleforms.1.2.1Thisdocumentationincludesinformationthatexplainshowtheusersinteractwithandoperatethesystem.Thismayincludeaterminaloperator''sguide,trainingdocumentation,systemoperationdescriptions,anddatabaseandfilemaintenanceinstructions.1.2.2Documentationalsoincludesreferencedocumentsthatdescribefunctionalandinternalcharacteristicsofthesystem,suchassoftwarereferencemanuals,sourcecode,descriptionsoffilestructures,hardwarereferencemanuals,schematics,andflowcharts.Paragraphsandmightapplywhensomeofthisinformationisproprietary.1.2.3Documentationincludestestprocedurestoestablishwhetherthesystemisinstalledcorrectlyandcontinuestooperateproperly.Thefrequencythatthetestsaretobeperformed,thetestdatasetstobeused,andwhethertheresultsaretobecomparedtomanualmethodsshouldbeprovided.1.3Thecomputersystemsunderconsiderationarethosedesignedtoassistthegeneralworkflowofthelaboratory.Theytypicallyincludesomeorallofthefollowingfeatures:sampletracking,datagathering,reportgeneration,recordkeeping,qualityassurance,managementaids,andhospitalcommunications.Theymayrangefromverylargetosmallcomputersystems.Computersdedicatedonlytoasingleinstrumentarenottheprimaryfocus.1.4Thisstandarddoesnotpurporttoaddressthesafetyproblemsassociatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:8P.;A4
【正文语种】:
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