产品策划设计开发控制程序指南性文件 风险管理报告 打印.docxVIP

Projectname:Homecare Muti-parameterRecorder(H10)Documentname:Risk managementreportWritten:Date:Auditor:Date:Approved:Date:RevisionRecordVer.Revision descriptionReviserDateTable ofContentsTable ofContentsChapter1SummaryChapter2CategoryChapter3 General Introduction3.1 Product Overview3.2 Intended Use3.3 CompositionChapter4 Members and Responsibility of RiskManagementChapter5 Determination of SafetyCharacteristicsChapter6 Summarization of the RiskManagementChapter7 Evaluation of the Residual RiskChapter8 Completeness Evaluation ofRiskChapter9 Information updating andrisk management aftermanufacturingAppendix A. Analysis methodA.1Harm analysismethodA.2 Risk estimatemethodAppendix B. Analysis MethodB.1 Estimation of the severity of each hazardB.2.Estimation of the likelihood of eachhazardB.3.Estimation of the acceptability of eachriskAppendixCAbbreviationsusedAppendixDContents ofTablesChapter1SummaryStandardinformationStandardISO14971:2012NameMedical devices-Application of risk management to medicaldevicesTest productinformationNameHomecare Muti-parameterRecorderModelH8ConfigurationMainframe,BPcuff,SpO2sensor,ECG cable and electrodes,Android PadPhotoH8ConclusionAllknownorforeseeablehazardshavebeenanalyzed.Aftercarryingoutcorresponding risk control measures, have not introduced any new hazards,andtherearenoALARPorN/ACCrisk,sotherisk/benefitanalysis is notnecessary.FailitemNothingRemarkNothingChapter2CategoryCategoryThis document is established according to standard ISO14971:2012 the risk management for medical devices. The goal is to systematically carry out the effective management of the various risk processes for the company’s RD and manufacture of Homecare multi-parameter recorder, The document is the instructive direction for design, confirmation, production and sales, and for CE authentication, FDA authentication and SFDA authentication constituent.Relative supportingdocumentItemStandardDescription1MDD 93/42/EECMedical Devices Directive: COUNCIL DIRECTIVE 2007/47/