DIN VDE 0753-4-2009 透析治疗中医疗产品的安全使用指南
作者:标准资料网 时间:2024-05-16 14:50:57 浏览:8586
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Guidelineforthesafeuseofmedicalproductsindialysistreatment-TextinGermanandEnglish
【原文标准名称】:透析治疗中医疗产品的安全使用指南
【标准号】:DINVDE0753-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-05
【实施或试行日期】:2009-05-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:应用规则;应用;人工肾;输血设备;定义;渗析;文献;电气工程;电气安全;电医学;设备安全;血液透析器;血透析;血透析设备;卫生学;使用说明书;维护;医疗设备;医学科学;多语种的;计划;质量保证;质量管理;安全;安全工程;安全要求;规范(验收);治疗学;治疗设备
【英文主题词】:Applicationrule;Applications;Artificialkidneys;Bloodtransfusionequipment;Definitions;Dialysis;Documentations;Electricalengineering;Electricalsafety;Electromedicine;Equipmentsafety;Haemodialysers;Haemodialysis;Haemodialysisequipment;Hygiene;Instructionsforuse;Maintenance;Medicalequipment;Medicalsciences;Multilingual;Planning;Qualityassurance;Qualitymanagement;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Therapeutics;Therapyequipment
【摘要】:ThepresentapplicationprinciplesdescribethetechnicalrequirementsforuseofequipmentinHAEMODIALYSIS,HAEMOFILTRATIONandHAEMODIAFILTRATION.Theseprinciplesmustbecompliedwithtoensuresafe,permissibleandproperapplication.Dialysistreatmentasawholeisamedicaltreatmentandlies,therefore,intheattendingphysician'sresponsibility.However,theORGANISATIONadministeringthetreatmentisresponsibleforallresources,structuresandprocessesusedinconnectionwiththetreatment.Theseresponsibilitieswillnotbedescribedhere.Ifapplicable,theapplicationprinciplescanalsobeusedforotherextracorporealbloodtreatmentprocedures.However,differentrequirementsmaybeapplicabletotheuseofequipmentinpaediatricsandhomeHAEMODIALYSIS.Today,thesafetystandardofSYSTEMSforextracorporealrenalreplacementtherapyisveryhigh.ThissafetystandardrelievestheOPERATORinmanyareaswhilealsoprotectingthePATIENT.Forexample,itensuresmonitoringofthetemperatureoftheDIALYSINGFLUIDandpreventsairinfusionduringthedialysistreatmentthroughtechnicalstructures.ThisisexpressedbytheCEmarkappliedtothemedicaldevices[9].Despitethehighsafetylevelofthemedicaldevices,theOPERATORisresponsiblefortheresidualrisk.Theresidualriskrelatestomedical-biological,physical-chemicalandtechnicalHAZARDS.
【中国标准分类号】:C39
【国际标准分类号】:11_040_20
【页数】:57P.;A4
【正文语种】:
【原文标准名称】:透析治疗中医疗产品的安全使用指南
【标准号】:DINVDE0753-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-05
【实施或试行日期】:2009-05-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:应用规则;应用;人工肾;输血设备;定义;渗析;文献;电气工程;电气安全;电医学;设备安全;血液透析器;血透析;血透析设备;卫生学;使用说明书;维护;医疗设备;医学科学;多语种的;计划;质量保证;质量管理;安全;安全工程;安全要求;规范(验收);治疗学;治疗设备
【英文主题词】:Applicationrule;Applications;Artificialkidneys;Bloodtransfusionequipment;Definitions;Dialysis;Documentations;Electricalengineering;Electricalsafety;Electromedicine;Equipmentsafety;Haemodialysers;Haemodialysis;Haemodialysisequipment;Hygiene;Instructionsforuse;Maintenance;Medicalequipment;Medicalsciences;Multilingual;Planning;Qualityassurance;Qualitymanagement;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Therapeutics;Therapyequipment
【摘要】:ThepresentapplicationprinciplesdescribethetechnicalrequirementsforuseofequipmentinHAEMODIALYSIS,HAEMOFILTRATIONandHAEMODIAFILTRATION.Theseprinciplesmustbecompliedwithtoensuresafe,permissibleandproperapplication.Dialysistreatmentasawholeisamedicaltreatmentandlies,therefore,intheattendingphysician'sresponsibility.However,theORGANISATIONadministeringthetreatmentisresponsibleforallresources,structuresandprocessesusedinconnectionwiththetreatment.Theseresponsibilitieswillnotbedescribedhere.Ifapplicable,theapplicationprinciplescanalsobeusedforotherextracorporealbloodtreatmentprocedures.However,differentrequirementsmaybeapplicabletotheuseofequipmentinpaediatricsandhomeHAEMODIALYSIS.Today,thesafetystandardofSYSTEMSforextracorporealrenalreplacementtherapyisveryhigh.ThissafetystandardrelievestheOPERATORinmanyareaswhilealsoprotectingthePATIENT.Forexample,itensuresmonitoringofthetemperatureoftheDIALYSINGFLUIDandpreventsairinfusionduringthedialysistreatmentthroughtechnicalstructures.ThisisexpressedbytheCEmarkappliedtothemedicaldevices[9].Despitethehighsafetylevelofthemedicaldevices,theOPERATORisresponsiblefortheresidualrisk.Theresidualriskrelatestomedical-biological,physical-chemicalandtechnicalHAZARDS.
【中国标准分类号】:C39
【国际标准分类号】:11_040_20
【页数】:57P.;A4
【正文语种】:
下载地址: 点击此处下载