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The essential principles of safety and performance of in vitro diagnostic medical devices

The essential principles of safety and performance of in vitro diagnostic medical devices

ID：40103746

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页数：30页

时间：2019-07-21

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1、GHTF/SG1/N063:2011FINALDOCUMENTGlobalHarmonizationTaskForceTitle:SummaryTechnicalDocumentation(STED)forDemonstratingConformitytotheEssentialPrinciplesofSafetyandPerformanceofInVitroDiagnosticMedicalDevicesAuthoringGroup:StudyGroup1oftheGlobalHarmonizationTaskForcethDate:Mar

2、ch17,2011SummaryTechnicalDocumentationforDemonstratingConformitytotheEssentialPrinciplesofSafetyandPerformanceofIVDMedicalDevices(STED)StudyGroup1FinalDocumentGHTF/SG1/SG1/N063:2011TableofContents1.0Introduction...............................................................

3、..............................................52.0Rationale,PurposeandScope................................................................................52.1Rationale..........................................................................................................

4、.....................52.2Purpose.................................................................................................................................62.3Scope........................................................................................................

5、.............................63.0References................................................................................................................64.0Definitions........................................................................................................

6、........75.0PreparationandUseoftheSTED..........................................................................85.1Preparation..........................................................................................................................85.2TheUseoftheSTEDintheP

7、remarketPhase..................................................................95.3TheUseoftheSTEDinthePost-marketPhase.............................................................115.4TheUseoftheSTEDtoNotifyChangestotheRA/CAB...............................................1

8、16.0DeviceDescriptionincludingVariants(Configurations)andAccessories..............

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