软件风险管理安全特征问题清单 IECTR80002-1VIP专享VIP免费

RISKMANAGEMENTREPORTVersion：A/0Appendix2ListofSafetyCharacteristicsofXXXXXXThelistisbasedonthelistofquestionsinAppendixBoftheIECTR80002-1-2009.Theintendeduseandsafety-relatedcharacteristicsofthemedicaldevicearejudged.Thesafetycharacteristicsoftheproductareknown.Furtherriskanalysislaysthefoundation.ItemQuestionDeterminesafetyfeaturesPotentialhazardHarmNo.ThefollowingquestionsarebasedonAppendixBoftheIECTR80002-1-2009B.1Alarmsandalerts:B1.1DospecificationsidentifyhowtheSYSTEMreactstomultiplealarmconditions?B1.1.1Aretheremultiplelevelsofalarms?Dohigherlevelalarmsoverridetheaudioforlowerlevelalarms?B1.1.2Shouldanyofthealarmspersistuntiltheusercanacknowledgethealarm?B.1.2Doestheprotectiveactioncreateausabilityproblem,i.e.cantheusersafelynavigatefromtheprotectiveaction?B.1.3IssafemodeactionappropriateforINTENDEDUSE?Hastheclinicalstaffreviewedsafemodescenarios?Issafemodestateapparenttotheuser?B.1.4Hastheclinicalstaffreviewedprotectivemeasuresforusability?B.1.5Aredetectederrorslogged?Isloglargeenough?Islogstoragereliable?Howislogcleared?B.1.6HasINTENDEDUSEenvironmentbeenconsideredforaudiblealarmdesign?B.1.6.1Haveusersbeeninvolvedindevelopingrequirementsforuserinterfacedesign?B.1.6.2HowisaudioSYSTEMverifiedperpoweruporperpatient?B.2CriticalpowercyclestatesB.2.1Whathappenstoamemory1/7ItemQuestionDeterminesafetyfeaturesPotentialhazardHarmNo.writethatwasinprogresswhenpowerwaslost?B.2.1.1Isthesoftwaremadeawareofimpendingpowerloss?B.2.1.2Isnon-volatilestorageverifiedonpowerup?B.2.1.3Arecriticalparameterscheckedbeforeuse?B.2.2IsresetbeingusedasaRISKCONTROLmeasure?B.2.2.1Willinput/outputcontrolbecompromisedduringresetcycle?B.2.2.2Isusermadeawareofresets?B.2.3IsrecoverytimeaSAFETYissue?B.2.3.1IsavailabilityoftheMEDICALDEVICEaSAFETYissue?B.2.3.2Howisnon-volatilestorageimpactedbyfailsafeprotectivemeasure?B.2.4AreanyRISKCONTROLmeasurescompromisedduringlowpowermodes?B.2.4Hassoftwarerecoveryfromlowpowermodesbeenconsideredasapossiblestart-upstateforVERIFICATIONandvalidationactivities?B.3CriticalusercontroIs/UsabilityB.3.1Isusernotifiedifadjustmentismadetoanewvaluebutneverselectedorconfirmed?B.3.1.1Shouldtheparameterbeingadjustedrequireatwo-stepoperationforchange?B.3.2Shoulduserbepromptedforconfirmation?B.3.2.1Doessoftwarecheckdataentryforvalidity?B.3.2.2Doesitrequiresupervisoryuserlogintoconfirmhighlycriticalinputsorerroroverrides?B.3.3Howmany“layers"mustusernavigatetoaccessSAFETY-relatedfunction?B.3.4Haveallautomaticscreenswitchesbeenevaluated?B.3.5Howwillcolorblindoperatorinterpreterrormessage?ItemQuestionDeterminesafetyfeaturesPotentialhazardHarmNo.B.3.5.1Haveusersbeeninvolvedindevelopingrequirementsforuserinterfacedesign?B.4DisplayB.4.1Isthereatechniquebeingusedtoensurecorrectorientationofimage?B.4.1.1Howareimagesassociatedwithpatient?B.4.2Whatfrequencycontentisrequiredfordisplay?B.4.2.1Hastheclinicalstaffreviewedthatrequirement?B.4.2.2Hasdisplayfilterbeenfullycharacterized,i.e.whatisrejectedandwhatispassed,overfullrangeofinputs?B.5HardwarecontrolsB.5.1Whatisthesamplingrate?B.5.1.1IfPIDcontrol,isintegralgainlimited?Hasalgorithmbeencharacterizedoverthefullvariationofmanufacturedhardware?B.5.1.2Iffeedbackcontrol,whatchecksaremadetothevalidityofthefeedbacksignal?B.5.1.3Havealldatatypesbeenevaluatedforthemicroprocessorandcompilerinuse?B.5.2Areallassertionscontinuouslyverifiedonascheduledbasi...