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CE认证产品常用标准清单
：
Serial
StandardandDescription
Scope
备注
Number/Version
MDD93/42/EEC
MedicalDeviceDirective(93/42/EEC)
EUregulation
欧盟有源医疗器械指
（IncludingDirective2007/47/EC
）
令
ENISO13485:
Medicaldevices
–Qualitymanagement
systems–Requirementsforregulatory
Qualitysystem
质量体系法规
2003/AC:2007
purposes
ENISO14971:
Medicaldevices
–Applicationofrisk
RiskManagement
风险管理标准
2007
managementtomedicaldevices
General
EN60601-1:
Medicalelectricalequipment
–Part1:
requirements:
医疗电子产品通用标
Generalrequirementsforbasicsafety
electricalsafety
2006+A1:2013
准
andessentialperformance
andessential
performance
Medicaldevicespart1-2:General
EN60601-1-2:
requirementsforsafetyandessential
General
医疗电子产品并列标
performance
–
requirements:
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Collateralstandards:
2014
准：EMC
electromagneticcompatibility
–Test
EMC
andrequirements
Medicaldevices
—Symbolstobeused
General
ISO15233-1:
withmedicaldevice
labels,labelingand
requirements:
医疗器械标签、作标记
2012
informationtobesupplied
—Part1:
MarkingsAppliedin
和提供信息的符号
Generalrequirements
Labels
Terminology,symbolsandinformation
General
医疗器械常用术语、标
EN1041:2008
requirements:
providedwithmedicaldevices
记
Terminology
ENISO10993-1:
Biological
evaluation
of
medical
devices
Biological
2009
–Part1:Evaluationandtesting
Evaluation
ENISO10993-5:
Biological
Evaluation
of
Medical
Devices
Biological
–Part5:
2009
Evaluation
TestsforInVitroCytotoxicity
生物相容性标准
Biological
Evaluation
of
Medical
Devices
ENISO10993-10:
–
Biological
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