GeneralSafetyandPerformanceRequirements(GSPRs_MDR)基本要求检查表.docx

GeneralSafetyandPerformanceRequirements

Report/File

AnnexIEssentialRequirements

accordingtoMDR2017/745

Device:

Trademark:

Manufacturer:

Distributor:

Accessories:

Draftedby: Date:

Reviewedby: Date:

Approvedby: Date

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GeneralSafetyandPerformanceRequirements

GeneralSafetyandPerformanceRequirements

WhenworkingwiththisdocumentpleaserefertotheMedicalDeviceRegulation2017/745asamended.Bluetext,neworrevisedrequirements

WhenworkingwiththisdocumentpleaserefertotheMedicalDeviceRegulation2017/745asamended.Bluetext,neworrevisedrequirements

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Clause

Description

Appli-cableornot?

Standard/Sub-clause(s)

Report/Document

Commentst

I

Generalrequirements

1.

Devicesshallachievetheperformanceintendedbytheirmanufacturerandshallbedesignedandmanufacturedinsuchawaythat,duringnormalconditionsofuse,theyaresuitablefortheirintendedpurpose.Theyshallbesafeandeffectiveandshallnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhichmaybeassociatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofprotectionofhealthandsafety,takingintoaccountthegenerallyacknowledgedstateoftheart.

装置应达到其制造商预期的性能，并且其设计和制造方式应使其在正常使用条件下适合其预期用途。它们应是安全有效的，不得损害患者的临床状况或安全，或用户或其他人（如适用）的安全和健康，前提是与使用它们相关的任何风险与患者的利益相比构成可接受的风险，并与高风险兼容。健康和安全保护水平，考虑到公认的最新技术。

A

Conformity

2.

TherequirementinthisAnnextoreducerisksasfaraspossiblemeansthereductionofrisksasfaraspossiblewithoutadverselyaffectingthebenefit-riskratio.

本附录中尽可能降低风险的要求指尽可能降低风险的同时不会对收益风险比产生不利影响。

A

Conformity

Clause

Description

Appli-cableornot?

Standard/Sub-clause(s)

Report/Document

Comments

3.

Manufacturersshallestablish,implement,documentandmaintainariskmanagementsystem.Riskmanagementshallbeun