ISO TR 20416-2020 医疗设备-上市后制造商监督

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Medicaldevices—Post-market

surveillanceformanufacturers

Dispositifsmédicaux—Surveillanceaprèsmisesurlemarché

incombantauxfabricants

©ISO2020

TECHNICAL

REPORT

ISO/TR

20416

Referencenumber

ISO/TR20416:2020(E)

Firstedition

2020-07

ISO/TR20416:2020(E)

ii©ISO2020–Allrightsreserved

©ISO2020

Phone:+41227490111

Website:www.iso.org

ISO/TR20416:2020(E)

Foreword........................................................................................................................................................................................................................................iv

Introduction..................................................................................................................................................................................................................................v

1Scope................................................................................................................................................................................................................................. 1

2Normativereferences...................................................................................................................................................................................... 1

.....................................................................................................................................................................................1

4Purposeofpost-marketsurveillanceprocess....................................................................................................................... 2

5Planningofpost-marketsurveillance............................................................................................................................................ 3

........................................................................................................................................................................................................... 3

................................................................................................................... 4

.......................................................................................................... 5

.............................................................................................................................................. 7

......................................................................................................................................................................................... 7

......................................................................................................................................................................... 7

......................................................................................................................

...................................................................................................... 9

............................................................................................................................................................................................. 9

...................................................................................................................................................................................... 9

.................................................................. 9

........................................................................................................................................ 9

................................................................................................................................................................ 10

...............................................................................................................................................11

6Reviewofthepost-marketsurveillanceplan......................................................................................................................12

6.1Purposeofthereview.................................................................................................................................................................... 12

6.3Review......................................................................................................................................................................................................... 13

AnnexAExamplesofdatasources.................................................................................................................................14

AnnexBExamplesofdataanalysismethods......................................................................................................25

AnnexCExamplesofpost-marketsurveillanceplans...............................................................................31

Bibliography.............................................................................................................................................................................................................................43

Contents

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标签： #医疗设备 #ISO

摘要：

Medicaldevices—Post-marketsurveillanceformanufacturersDispositifsmédicaux—Surveillanceaprèsmisesurlemarchéincombantauxfabricants©ISO2020TECHNICALREPORTISO/TR20416ReferencenumberISO/TR20416:2020(E)Firstedition2020-07ISO/TR20416:2020(E)ii©ISO2020–AllrightsreservedCOPYRIGHTPROTECTEDDOCUMENT©ISO2020Phon...

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ISO TR 20416-2020 医疗设备-上市后制造商监督

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