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RiskManagementreport
ProductName
XXX
Type/Model
XXX-XXX
Issuedate
5/11/2019
Release
Name
Occupation
Releasedate
Issued/changedby
Engineeringdepartment
10/11/2019
Checked/Approvedby
Qualitydepartment
20/11/2019
Checked/Approvedby
Engineeringdepartment
30/11/2019
Generalreleaseby
Engineeringdepartment
5/12/2019
Contents
1.Introduction
3
2.Scope
3
3.Applicationinformation
3
3.1Policy,directiveandstandard
3
3.2Theinformationofproduct
4
3.3Othersourceofinformation
4
3.4Teamofriskmanagement
4
3.5Instructionofproduct
4
4.Riskanalysis
4
4.1Riskanalysisprocedure
4
4.2Intendeduse/intendedpurposeandidentificationofcharacteristicsrelatedtothesafety
5-7
4.3IdentificationofknownorforeseeablehazardsandEstimationoftherisk(s)foreachhazard
7-10
5.RiskevaluationandRiskcontrol
11-18
6.Usageofinformationfromin/afterproductionandfollowup
6.1Risksarisingfromriskcontrolmeasures
6.2Completenessofriskevaluation
6.3Overallresidualriskevaluation
7.Evaluationofoverallriskacceptability
8.Annex
TABLE:Intendeduseandidentificationofcharacteristicsrelatedtothesafetyofthe
medicaldevicefromIEC60601-1
19
20
20
20
20
21-24
1.Introduction
ThisriskanalysiswasmadeinaccordancewithENISO14971:2012–Applicationofriskmanagementtomedicaldevices.
ThisriskanalysisreportispreparedforaBiteReliefdeviceorasimilarproduct.Theriskevaluationwasbasedonthefeedbackfromthemarketforsimilarproduct,andalsotheoverallexperiencesofourdevelopmentheadquarter–PerfectSteamAppliancesLimited,andalsotheopinionandexperiencefromthecustomer(s).
Allpossiblerisksareexamined,reducedandratedinthisriskanalysisreport.
Thisriskanalysiswillbereviewedannuallyorwheneveritisnecessarybecauseofe.g.newinformati
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