中英文可用性评价报告评价标准.pdf

EN60601-1-6

Medicalelectricalequipment

Part1-6:Generalrequirementsforsafety-CollateralStandard:Usability

EN62366

Medicaldevices

Applicationofusabilityengineeringtomedicaldevices

ReportReferenceNo

Compiledby(+signature)

Approvedby(+signature)

Dateofissue

Companyname

Address

Testspecification:

Standard:EN60601-1-6:2010,EN62366:2008

Testitemdescription

TradeMark

Manufacturer

Model/Typereference

Ratings

Possibletestcaseverdicts:

-testcasedoesnotapplytothetestobject:N/A

-testobjectdoesmeettherequirement:Pass(P)

-testobjectdoesnotmeettherequirement:Fail(F)

TestResult:Passed

EN60601-1-6

ClauseRequirement+TestResult-RemarkVerdict

Generalrequirements

4

总要求

ConditionsforapplicationtoMEEQUIPMENT

4.1

ME设备应用条件

TheMEEQUIPMENTshallprovideadequateUSABILITY

suchthattheRISKSresultingfromNORMALUSEandUSE

ERRORareacceptable.Seealso7.1.1and12.2ofthe

generalstandard.

ME设备应提供充分的可用性，使得由于正常使用和使用错

误导致的风险是可以接受的。参见通用标准的7.1.1和

12.2。

USABILITYENGINEERINGPROCESSforMEEQUIPMENT

4.2

ME设备的可用性工程程序

AUSABILITYENGINEERINGPROCESScomplyingwith

IEC62366shallbeperformed.

可用性工程程序按照IEC62366执行。

—established