CE认证标准清单.docx
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CE认证标准清单
CE认证产品常用标准清单
一.CE认证适用的一般标准：
SerialNumber/Version
StandardandDescription
Scope
备注
MDD93/42/EEC
MedicalDeviceDirective（93/42/EEC）
（IncludingDirective2007/47/EC）
EUregulation
欧盟有源医疗器械指令
ENISO13485:
2003/AC:
2007
Medicaldevices–Qualitymanagementsystems–Requirementsforregulatorypurposes
Qualitysystem
质量体系法规
ENISO14971:
2007
Medicaldevices–Applicationofriskmanagementtomedicaldevices
RiskManagement
风险管理标准
EN60601-1:
2006+A1:
2013
Medicalelectricalequipment–Part1:
Generalrequirementsforbasicsafetyandessentialperformance
Generalrequirements:
electricalsafetyandessentialperformance
医疗电子产品通用标准
EN60601-1-2:
2014
Medicaldevicespart1-2:
Generalrequirementsforsafetyandessentialperformance–Collateralstandards:
electromagneticcompatibility–Testandrequirements
Generalrequirements:
EMC
医疗电子产品并列标准：
EMC
ISO15233-1:
2012
Medicaldevices—Symbolstobeusedwithmedicaldevicelabels,labelingandinformationtobesupplied—Part1:
Generalrequirements
Generalrequirements:
MarkingsAppliedinLabels
医疗器械标签、作标记和提供信息的符号
EN1041:
2008
Terminology,symbolsandinformationprovidedwithmedicaldevices
Generalrequirements:
Terminology
医疗器械常用术语、标记
ENISO10993-1:
2009
Biologicalevaluationofmedicaldevices–Part1:
Evaluationandtesting
BiologicalEvaluation
生物相容性标准
ENISO10993-5:
2009
BiologicalEvaluationofMedicalDevices–Part5:
TestsforInVitroCytotoxicity
BiologicalEvaluation
ENISO10993-10:
2010
BiologicalEvaluationofMedicalDevices–Part10:
TestsforIrritationandDelayed-TypeHypersensitivity
BiologicalEvaluation
EN14155:
2011
Clinicalinvestigationofmedicaldevicesforhumansubjects-Goodclinicalpractice（ISO14155:
2011）
医学研究受验者用医疗器械的临床试验
MEDDEV2.7.1
GuidelinesonmedicaldevicesEvaluationofclinicaldata:
AguideformanufacturersandNotifiedBody
医疗器械临床评价
二.监护仪系列产品适用标准：
SerialNumber/Version
StandardandDescription
Scope
备注
EN60601-1-6:
2010
Medicalelectricalequipment–Part1-6:
Generalrequirementsforbasicsafetyandessentialperformance–CollateralStandard:
Usability.
Generalrequirements:
Usability
医疗电子产品并列标准：
可用性
EN60601-1-8:
2007
Medicalelectricalequipment–Part1-8:
Generalrequirementsforbasicsafetyandessentialperformance–Collateralstandard:
Generalrequirements,testsandguidanceforalarmsystemsinmedicalelectricalequipmentandmedicalelectricalsystems
Generalrequirements：
Alarmsystem
医疗电子产品并列标准：
报警系统
EN60601-2-49:
2011
MedicalElectricalEquipmentPart2-49:
Particularrequirementsforthebasicsafetyandessentialperformanceofmultifunctionpatientmonitoringequipment
Generalrequirements:
Patientmonitoring
医疗电子产品专用标准：
多参数监护仪
IEC60601-2-27:
2011
Medicalelectricalequipment-Part2-27:
Particularrequirementsforthebasicsafetyandessentialperformanceofelectrocardiographicmonitoringequipment
ECGmonitoring:
Safetyrequirements
医疗电子产品专用标准：
心电监护仪
EN60601-2-30:
2009
MedicalElectricalEquipmentPart2-30:
Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometers
Bloodpressuremonitoring:
Safetyrequirements
医疗电子产品专用标准：
无创血压计
ISO80601-2-61:
2011
Medicalelectricalequipment–Part2-61:
Particularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipment
SpO2:
Performancerequirement
医疗电子产品专用标准：
血氧设备
ISO80601-2-56:
2009
Medicalelectricalequipment–Part2-56:
Particularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasurement
Temperature:
Performancerequirement
医疗电子产品专用标准：
临床体温计
ISO80601-2-55:
2011
Medicalelectricalequipment–Part2-55:
Particularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitors
Respiratorygasmonitoring:
SafetyrequirementsPerformancerequirement.
医疗电子产品专用标准：
呼吸气体监护设备
三.生理参数检测仪适用标准：
SerialNumber/Version
StandardandDescription
Scope
备注
IEC60601-1-11:
2010
Medicalelectricalequipment–Part1-11:
Generalrequirementsforbasicsafetyand
essentialperformance–CollateralStandard:
Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment
Generalrequirements:
Homehealthcare
医疗电子产品并列标准：
家用健康环境
EN60601-2-30:
2009
MedicalElectricalEquipmentPart2-30:
Particularrequirementsforthesafetyandessentialperformanceofautomatednon-invasivesphygmomanometers
Bloodpressuremonitoring:
Safetyrequirements
医疗电子产品专用标准：
无创血压计
ISO80601-2-61:
2011
Medicalelectricalequipment–Part2-61:
Particularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipment
SpO2:
Performancerequirement
医疗电子产品专用标准：
血氧设备
ISO80601-2-56:
2009
Medicalelectricalequipment–Part2-56:
Particularrequirementsforbasicsafetyandessentialperformanceofclinicalthermometersforbodytemperaturemeasurement
Temperature:
Performancerequirement
医疗电子产品专用标准：
临床体温计
注：
生理参数检测含有的心电、血糖、无线传输功能并没有随产品做CE认证。
四.血氧系列产品（含血氧探头）适用标准：
SerialNumber/Version
StandardandDescription
Scope
备注
IEC60601-1-11:
2010
Medicalelectricalequipment–Part1-11:
Generalrequirementsforbasicsafetyand
essentialperformance–CollateralStandard:
Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment
Generalrequirements:
Homehealthcare
医疗电子产品并列标准：
家用健康环境
ISO80601-2-61:
2011
Medicalelectricalequipment–Part2-61:
Particularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipment
SpO2:
Performancerequirement
医疗电子产品专用标准：
血氧设备
注：
血氧探头没有IEC60601-1-11:
2010标准。
五.多普勒胎心仪适用标准：
SerialNumber/Version
StandardandDescription
Scope
备注
IEC60601-1-11:
2010
Medicalelectricalequipment–Part1-11:
Generalrequirementsforbasicsafetyand
essentialperformance–CollateralStandard:
Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment
Generalrequirements:
Homehealthcare
医疗电子产品并列标准：
家用健康环境
IEC60601-2-37:
2007
MedicalelectricalequipmentPart2-37:
Particularrequirementsforthebasicsafetyandessentialperformanceofultrasonicmedicaldiagnosticandmonitoringequipment
Fetalmonitoring:
Requirementsforsafetyandperformance
医疗电子产品专用标准：
超声诊断和监护设备
六.快速心电检测仪适用标准：
SerialNumber/Version
StandardandDescription
Scope
备注
IEC60601-1-11:
2010
Medicalelectricalequipment–Part1-11:
Generalrequirementsforbasicsafetyand
essentialperformance–CollateralStandard:
Requirementsformedicalelectricalequipmentandmedicalelectricalsystemsusedinthehomehealthcareenvironment
Generalrequirements:
Homehealthcare
医疗电子产品并列标准：
家用健康环境
备注：
第一部分属于常用标准，适用于公司做过CE认证的所有医疗产品，后面是根据产品的功能、特性附加的标准。
所以一般情况下，可用第一部分加上其他部分即可组成具体产品的适用标准。
升级会员 