CE注册常用标准清单

在进行产品CE注册的时候，都需要列出产品适用的标准清单，本文列出常见的产品通用标准，以及一些常见有源产品的专用标准。

（更新到年9月3日）

Standards/Regulations/Directive

BriefIntroduction

法规

MDD93/42/EEC/47/EC

COUNCILDIRECTIVE93/42/EECof14Juneconcerningmedicaldevices

MDRREGULATIONS(EU)/

MedicalDeviceRegulation

质量体系

ENISO:

Medicaldevices-Qualitymanagementsystems,Requirementsforregulatorypurposes

说明书和标签

ENISO-1:

Medicaldevices-Symbolstobeusedwithmedicaldevicelabels,labellingandinformationtobesupplied-Part1:Generalrequirements(ISO-1:,Correctedversion-03)

EN:+A1:

Informationsuppliedbythemanufacturerwithmedicaldevices

BSEN:

Symbolsforuseinthelabellingofmedicaldevices

风险管理

ENISO:

Medicaldevices-Applicationofriskmanagementtomedicaldevices

临床研究/评估

ENISO:

Clinicalinvestigationofmedicaldevicesforhumansubjects─Goodclinicalpractice

MEDDEV2.7.1:rev.4

Clinicalevaluation:aguideformanufactureandnotifiedbodiesunderdirectives93/42/EECand90/EEC

安规EMC

EN-1:/A12:

IEC-1:/A1:

Medicalelectricalequipment-Part1:Generalrequirementsforbasicsafetyandessentialperformance

EN-1-2:

IEC-1-2:

Medicalelectricalequipment-Part1-2:Generalrequirementsforbasicsafetyandessentialperformance-Collateralstandard:Electromagnetic