中英文-可用性评价报告-评价标准.pdf

产品名称:

可用性评价报告

文件编号：编制：

采用标准：EN60601-1-6:2010,EN62366:2008审核：

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

Page1of10

产品名称:

可用性评价报告

文件编号：JKH-编制：

采用标准：EN60601-1-6:2010,EN62366:2008审核：

EN60601-1—6

ClauseRequirement+TestResult-RemarkVerdict

4Generalrequirements

总要求

ConditionsforapplicationtoMEEQUIPMENT

4。1

ME设备应用条件

TheMEEQUIPMENTshallprovideadequateUSAB