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#GHTF/SG1/N41R9:2005FINALDOCUMENTTitle:EssentialPrinciplesofSafetyandPerformanceofMedicalDevicesAuthoringGroup:GHTFStudyGroup1Endorsedby:TheGlobalHarmonizationTaskForceDate:May20,2005AbraaoCarvalho,GHTFChairThisdocumentwasproducedbytheGlobalHarmonizationTaskForce,avoluntaryinternationalgroupofrepresentativesfrommedicaldeviceregulatoryauthoritiesandtradeassociationsfromEurope,theUnitedStatesofAmerica(USA),Canada,JapanandAustralia.Thedocumentisintendedtoprovidenon—bindingguidancetoregulatoryauthoritiesforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment。Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.Copyright?2000bytheGlobalHarmonizationTaskForceTableofContents121。Introduction12TOC\o"1-5"\h\z\o"CurrentDocument"Rationale.PurposeandScope13\o"CurrentDocument"2。1Rationale13\o"CurrentDocument"Purpose13\o"CurrentDocument"2。3Scope14\o"CurrentDocument"3。References14

4.Definitions154.Definitions15165。EssentialPrinciplesofSafetyandPerformanceofMedicalDevices16PrefaceThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryauthoritiesandtheregulatedindustry。Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestrictionsonthereproduction,distribution,translationoruseofthisdocumenthowever,incorporationofthisdocument,inpartorinwhole,intoanyotherdocumentdoesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.IntroductionTheprimarywayinwhichtheGHTFachievesitsgoalsisthroughtheproductionofaseriesofguidancedocumentsthattogetherdescribeaglobalregulatorymodelformedicaldevices.Thepurposeofsuchguidanceistoharmonizethedocumentationandproceduresthatareusedtoassesswhetheramedicaldeviceconformstotheregulationsthatapplyineachjurisdiction.Eliminatingdifferencesbetweenjurisdictionsdecreasesthecostofgainingregulatorycomplianceandallowspatientsearlieraccesstonewtechnologiesandtreatments。Thisdocumenthasbeendevelopedtoencourageandsupportglobalconvergenceofregulatorysystems.ItisintendedforusebyRegulatoryAuthorities,ConformityAssessmentBodiesandindustry,andwillprovidebenefitsinestablishing,inaconsistentway,aneconomicandeffectiveapproachtothecontrolofmedicaldevicesintheinterestofpublichealth。ItseekstostrikeabalancebetweentheresponsibilitiesofRegulatoryAuthoritiestosafeguardthehealthoftheircitizensandtheirobligationstoavoidplacingunnecessaryburdensupontheindustry。StudyGroup1oftheGHTFsupportsandencouragesregulatoryharmonizationbutrecognisesthatsomeRegulatoryAuthoritiesmayhavetoreflectdifferentlocalneedswhentheyintroducenewregulationsonconformityassessment。However,RegulatoryAuthoritiesthataredevelopingconformityassessmentschemesoramendingexistingonesareencouragedtoconsidertheadoptionofthesystemdescribedinthisdocument,asthiswillhelptoreducethediversityofschemesworldwideandfacilitatetheprocessofharmonization.TheGHTFhasidentifiedasaprioritytheneedtoharmonizeessentialsafetyandperformancecriteriaforamedicaldevicethatallowthemanufacturertodemonstrateitsproductissuitableforitsintendeduse。ThisgoalwasachievedthroughthepublicationofguidanceonthesubjectentitledEssentialPrinciplesofSafetyandPerformanceofMedicalDevices(SG1/N020ofJune30,1999)thatappliedtothemajorityofmedicaldevicesbutnottoinvitrodiagnosticdevices.Thiscurrentdocumentsupersedesthatearlierone.Themajordifferencebetweenthemistheexpandedscope;thisdocumentnowincludesmedicaldevicesfortheinvitroexaminationofspecimensderivedfromthehumanbody.Theregulatoryrequirementsofsomecountriesdonot,atthistime,alignfullywiththisguidance.StudyGroup1oftheGlobalHarmonizationTaskForce(GHTF)haspreparedthisguidancedocument.CommentsorquestionsaboutitshouldbedirectedtoeithertheChairmanorSecretaryofGHTFStudyGroup1whosecontactdetailsmaybefoundontheGHTFwebpage1Rationale,PurposeandScopeRationaleConsistentidentification,selectionandapplicationofsafetyandperformanceprinciplestoamedicaldeviceofferssignificantbenefitstothemanufacturer,user,patientorconsumer,andtoRegulatoryAuthoritiessinceitallowsitsmanufacturertodesign,manufactureanddemonstratethedeviceissuitableforitsintendeduse。Moreover,eliminatingdifferencesbetweenjurisdictionsdecreasesthecostofgainingregulatorycomplianceandallowspatientsearlieraccesstonewtechnologiesandtreatments.PurposeTodescribesixgeneralrequirementsofsafetyandperformancethatapplytoallmedicaldevices.Toprovideacomprehensivelistofdesignandmanufacturingrequirementsofsafetyandperformance,someofwhicharerelevanttoeachmedicaldevice.Thesearegroupedas:Chemical,physicalandbiologicalproperties.Infectionandmicrobialcontamination.Manufacturingandenvironmentalproperties.Deviceswithadiagnosticormeasuringfunction。Protectionagainstradiation.Requirementsformedicaldevicesconnectedtoorequippedwithanenergysource.Protectionagainstmechanicalrisks。Protectionagainsttherisksposedtothepatientbysuppliedenergyorsubstances.Protectionagainsttherisksposedtothepatientfordevicesforself—testingorselfadministration.Informationsuppliedbythemanufacturer.Performanceevaluationincluding,whereappropriate,clinicalevaluation。Note:themanufacturerselectswhichofthedesignandmanufacturingrequirementsarerelevanttoaparticularmedicaldevice,documentingthereasonsforexcludingtheothers.TheRegulatoryAuthorityand/orConformityAssessmentBodymayverifythisdecisionduringtheconformityassessmentprocess.ScopeThisdocumentappliestoallproductsthatfallwithinthedefinitionofamedicaldevicethatappearswithintheGHTFdocumentInformationDocumentConcerningtheDefinitionoftheTerm“MedicalDevice”,includingthoseusedfortheinvitroexaminationofspecimensderivedfromthehumanbody。ReferencesGHTFfinaldocumentsSG1/N009LabellingforMedicalDevicesSG1/N012RoleofStandardsintheAssessmentofMedicalDevices.SG1/N020EssentialPrinciplesofSafetyandPerformanceofMedicalDevicesGHTFdocumentsavailableforpubliccommentSG1(PD)/N011SummaryTechnicalDocumentationforDemonstratingConformitytotheEssentialPrinciplesofSafetyandPerformanceofMedicalDevices.SG1(PD)/N029InformationDocumentConcerningtheDefinitionoftheTerm‘MedicalDevice'.SG1(PD)/N043LabellingforMedicalDevices(revised).GHTFdocumentbeingpreparedforpubliccommentSG1(PD)/N040PrinciplesofConformityAssessmentforMedicalDevices。InternationalstandardISO14971:2001Medicaldevices—Applicationofriskmanagementtomedicaldevices.ISO/TR16142:2004MedicalDevices—GuidanceontheSelectionofStandardsinSupportoftheRecognizedEssentialPrinciplesofSafetyandPerformanceofMedicalDefinitionsClinicalevaluation:Thereviewofrelevantscientificliteratureand/orthereviewandassessmentofdatacollectedthroughclinicalinvestigation。Clinicalinvestigation:Anydesignedandplannedsystematicstudyinhumansubjectsundertakentoverifythesafetyand/orperformanceofaspecificdevice。(Source—ISO/DIS14155—1)Deviceforself—testing/self—administration:Anydeviceintendedbythemanufacturertobeabletobeusedbylaypersonsinanon-clinicalenvironment。(Source—basedonEuropeanDirective98/79/EC)Harm:Physicalinjuryordamagetothehealthofpeopleordamagetopropertyortheenvironment.(Source—ISO/IECGuide51:1999)Hazard:Potentialsourceofharm.(Source—ISO/IECGuide51:1999)Intendeduse/purpose:Theobjectiveintentofthemanufacturerregardingtheuseofaproduct,processorserviceasreflectedinthespecifications,instructionsandinformationprovidedbythemanufacturer.(Source—21CFR801.4)Medicaldevice:RefertoGHTFguidancedocument:InformationConcerningtheDefinitionoftheTerm“MedicalDevice"(SG1/N029).Performanceevaluation:Reviewoftheperformanceofamedicaldevicebasedupondataalreadyavailable,scientificliteratureand,whereappropriate,laboratory,animalorclinicalinvestigations。RegulatoryAuthority(RA):Agovernmentagencyorotherentitythatexercisesalegalrighttocontroltheuseorsaleofmedicaldeviceswithinitsjurisdiction,andmaytakeenforcementactiontoensurethatmedicalproductsmarketedwithinitsjurisdictioncomplywithlegalrequirements。(Source—EU—CanadaMRA)Risk:Combinationoftheprobabilityofoccurrenceofharmandtheseverityofthatharm.(Source—ISO/IECGuide51:1999)Specimen:Thediscreteportionofabodyfluidortissueorothersampleassociatedwiththebodytakenforexamination,study,oranalysisofoneormorequantityorcharacteristictodeterminethecharacterofthewhole.EssentialPrinciplesofSafetyandPerformanceofMedicalDevicesGeneralRequirementsMedicaldevicesshouldbedesignedandmanufacturedinsuchawaythat,whenusedundertheconditionsandforthepurposesintendedand,whereapplicable,byvirtueofthetechnicalknowledge,experience,educationortrainingofintendedusers,theywillnotcompromisetheclinicalconditionorthesafetyofpatients,orthesafetyandhealthofusersor,whereapplicable,otherpersons,providedthatanyriskswhichmaybeassociatedwiththeiruseconstituteacceptableriskswhenweighedagainstthebenefitstothepatientandarecompatiblewithahighlevelofprotectionofhealthandsafety。Thesolutionsadoptedbythemanufacturerforthedesignandmanufactureofthedevicesshouldconformtosafetyprinciples,takingaccountofthegenerallyacknowledgedstateoftheart.Whenriskreductionisrequired,themanufacturershouldcontroltherisk(s)sothattheresidualrisk(s)associatedwitheachhazardisjudgedacceptable.Themanufacturershouldapplythefollowingprinciplesinthepriorityorderlisted:identifyknownorforeseeablehazardsandestimatetheassociatedrisksarisingfromtheintendeduseandforeseeablemisuse,eliminaterisksasfarasreasonablypracticablethroughinherentlysafedesignandmanufacture,reduceasfarasisreasonablypracticabletheremainingrisksbytakingadequateprotectionmeasures,includingalarms,informusersofanyresidualrisks.Devicesshouldachievetheperformanceintendedbythemanufacturerandbedesigned,manufacturedandpackagedinsuchawaythattheyaresuitableforoneormoreofthefunctionswithinthescopeofthedefinitionofamedicaldeviceapplicableineachjurisdiction.ThecharacteristicsandperformancesreferredtoinClauses5.1,5.2and5.3shouldnotbeadverselyaffectedtosuchadegreethatthehealthorsafetyofthepatientortheuserand,whereapplicable,ofotherpersonsarecompromisedduringthelifetimeofthedevice,asindicatedbythemanufacturer,whenthedeviceissubjectedtothestresseswhichcanoccurduringnormalconditionsofuseandhasbeenproperlymaintainedinaccordancewiththemanufacturer'sinstructions。Thedevicesshouldbedesigned,manufacturedandpackedinsuchawaythattheircharacteristicsandperformancesduringtheirintendedusewillnotbeadverselyaffectedundertransportandstorageconditions(forexample,fluctuationsoftemperatureandhumidity)takingaccountoftheinstructionsandinformationprovidedbythemanufacturer。Thebenefitsmustbedeterminedtooutweighanyundesirablesideeffectsfortheperformancesintended。DesignandManufacturingRequirementsChemical,physicalandbiologicalpropertiesThedevicesshouldbedesignedandmanufacturedinsuchawayastoensurethecharacteristicsandperformancereferredtoinClauses5.1to5.6ofthe'GenerRaelquirements'。Particularattentionshouldbepaidto:?thechoiceofmaterialsused,particularlyasregardstoxicityand,whereappropriate,flammability,?thecompatibilitybetweenthematerialsusedandbiologicaltissues,cells,bodyfluids,andspecimens,takingaccountoftheintendedpurposeofthedevice。?thechoiceofmaterialsusedshouldreflect,whereappropriate,matterssuchashardness,wearandfatiguestrength。Thedevicesshouldbedesigned,manufacturedandpackedinsuchawayastominimizetheriskposedbycontaminantsandresiduestothepersonsinvolvedinthetransport,storageanduseofthedevicesandtopatients,takingaccountoftheintendedpurposeoftheproduct.Particularattentionshouldbepaidtotissuesexposedandtothedurationandfrequencyofexposure。Thedevicesshouldbedesignedandmanufacturedinsuchawaythattheycanbeusedsafelywiththematerials,substancesandgaseswithwhichtheyenterintocontactduringtheirnormaluseorduringroutineprocedures;ifthedevicesareintendedtoadministermedicinalproductstheyshouldbedesignedandmanufacturedinsuchawayastobecompatiblewiththemedicinalproductsconcernedaccordingtotheprovisionsandrestrictionsgoverningtheseproductsandthattheirperformanceismaintainedinaccordancewiththeintendeduse。Whereadeviceincorporates,asanintegralpart,asubstancewhich,ifusedseparately,maybeconsideredtobeamedicinalproduct/drugasdefinedintherelevantlegislationthatapplieswithinthatjurisdictionandwhichisliabletoactuponthebodywithactionancillarytothatofthedevice,thesafety,qualityandusefulnessofthesubstanceshouldbeverified,takingaccountoftheintendedpurposeofthedevice.Thedevicesshouldbedesignedandmanufacturedinsuchawayastoreduceasfarasreasonablypracticableandappropriatetherisksposedbysubstancesthatmayleachorleakfromthedevice。Devicesshouldbedesignedandmanufacturedinsuchawayastoreduceasfarasreasonablypracticableandappropriaterisksposedbytheunintentionalingressoregressofsubstancesintoorfromthedevicetakingintoaccountthedeviceandthenatureoftheenvironmentinwhichitisintendedtobeused.InfectionandmicrobialcontaminationThedevicesandmanufacturingprocessesshouldbedesignedinsuchawayastoeliminateortoreduceasfarasreasonablypracticableandappropriatetheriskofinfectiontopatients,usersand,whereapplicable,otherpersons.Thedesignshould:?alloweasyhandling,and,wherenecessary:?reduceasfarasreasonablypracticableandappropriateanymicrobialleakagefromthedeviceand/ormicrobialexposureduringuse,?preventmicrobialcontaminationofthedevice,orspecimenwhereapplicable,bythepatient,userorotherperson.Whereadeviceincorporatessubstancesofbiologicalorigin,theriskofinfectionmustbereducedasfarasreasonablypracticableandappropriatebyselectingappropriatesources,donorsandsubstancesandbyusing,asappropriate,validatedinactivation,conservation,testandcontrolprocedures.Insomejurisdictionsproductsincorporatingtissues,cellsandsubstancesofnonhumanoriginmaybeconsideredmedicaldevices.Inthiscase,suchtissues,cellsandsubstancesshouldoriginatefromanimalsthathavebeensubjectedtoveterinarycontrolsandsurveillanceadaptedtotheintendeduseofthetissues。Nationalregulationsmayrequirethatthemanufacturerand/ortheRegulatoryAuthorityretaininformationonthegeographicaloriginoftheanimals。Processing,preservation,testingandhandlingoftissues,cellsandsubstancesofanimaloriginshouldbecarriedoutsoastoprovideoptimalsafety.Inparticular,safetywithregardtovirusesandothertransmissibleagentsshouldbeaddressedbyimplementationofvalidatedmethodsofp???????T?eliminationorinactivationinthecourseofthemanufacturingprocess。Insomejurisdictionsproductsincorporatinghumantissues,cellsandsubstancesmaybeconsideredmedicaldevices.Inthiscase,theselectionofsources,donorsand/orsubstancesofhumanorigin,theprocessing,preservation,testingandhandlingoftissues,cellsandsubstancesofsuchoriginshouldbecarriedoutsoastoprovideoptimalsafety.Inparticular,safetywithregardtovirusesandothertransmissibleagentsshouldbeaddressedbyimplementationofvalidatedmethodsofeliminationorinactivationinthecourseofthemanufacturingprocess。Deviceslabelledashavingaspecialmicrobiologicalstateshouldbedesigned,manufacturedandpackedtoensuretheyremainsowhenplacedonthemarketandremainsounderthetransportandstorageconditionsspecifiedbythemanufacturer.Devicesdeliveredinasterilestateshouldbedesigned,manufacturedandpackedinanon-reusablepack,and/oraccordingtoappropriateprocedures,toensurethattheyaresterilewhenplacedonthemarketandremainsterile,underthetransportandstorageconditionsindicatedbythemanufacturer,untiltheprotectivepackagingisdamagedoropened。Deviceslabelledeitherassterileorashavingaspecialmicrobiologicalstateshouldhavebeenprocessed,manufacturedand,ifapplicable,sterilizedbyappropriate,validatedmethods.Devicesintendedtobesterilizedshouldbemanufacturedinappropriatelycontrolled(e.g。environmental)conditions.Packagingsystemsfornon—steriledevicesshouldkeeptheproductwithoutdeteriorationatthelevelofcleanlinessstipulatedand,ifthedevicesaretobesterilizedpriortouse,minimizetheriskofmicrobialcontamination;thepackagingsystemshouldbesuitabletakingaccountofthemethodofsterilizationindicatedbythemanufacturer.Thepackagingand/orlabelofthedeviceshoulddistinguishbetweenidenticalorsimilarproductsplacedonthemarketinbothsterileandnon—sterilecondition。5.9ManufacturingandenvironmentalpropertiesIfthedeviceisintendedforuseincombinationwithotherdevicesorequipment,thewholecombination,includingtheconnectionsystemshouldbesafeandshouldnotimpairthespecifiedperformanceofthedevices。Anyrestrictionsonuseapplyingtosuchcombinationsshouldbeindicatedonthelabeland/orintheinstructionsforuse。Devicesshouldbedesignedandmanufacturedinsuchawayastoremoveorreduceasfarasreasonablypracticableandappropriate:?theriskofinjury,inconnectionwiththeirphysicalfeatures,includingthevolume/pressureratio,dimensionalandwhereappropriateergonomicfeatures;?risksconnectedwithreasonablyforeseeableexternalinfluencesorenvironmentalconditions,suchasmagneticfields,externalelectricalandelectromagneticeffects,electrostaticdischarge,pressure,humidity,temperatureorvariationsinpressureandacceleration;?herisksconnectedtotheiruseinconjunctionwithmaterials,substancesandgaseswithwhichtheymaycomeintocontactduringnormalconditionsofuse;?therisksofaccidentalpenetrationofsubstancesintothedevice;?theriskofincorrectidentificationofspecimens;?therisksofreciprocalinterferencewithotherdevicesnormallyusedintheinvestigationsorforthetreatmentgiven;?risksarisingwheremaintenanceorcalibrationarenotpossible(aswithimplants),fromageingofmaterialsusedorlossofaccuracyofanymeasuringorcontrolmechanism.Devicesshouldbedesignedandmanufacturedinsuchawayastominimizetherisksoffireorexplosionduringnormaluseandinsinglefaultcondition。Particularattentionshouldbepaidtodeviceswhoseintendeduseincludesexposuretooruseinassociationwithflammablesubstancesorsubstanceswhichcouldcausecombustion.Devicesmustbedesignedandmanufacturedinsuchawayastofacilitatethesafedisposalofanywastesubstances。DeviceswithadiagnosticormeasuringfunctionDeviceswithameasuringfunction,whereinaccuracycouldhaveasignificantadverseeffectonthepatient,shouldbedesignedandmanufacturedinsuchawayastoprovidesufficientaccuracy,precisionandstabilityfortheirintendedpurposeofthedevice。Thelimitsofaccuracyshouldbeindicatedbythemanufacturer。Diagnosticdevicesshouldbedesignedandmanufacturedinsuchawayastoprovidesufficientaccuracy,precisionandstabilityfortheirintendeduse,basedonappropriatescientificandtechnicalmethods。Inparticularthedesignshouldaddresssensitivity,specificity,trueness,repeatability,reproducibility,controlofknownrelevantinterferenceandlimitsofdetection,asappropriate。Wheretheperformanceofdevicesdependsontheuseofcalibratorsand/orcontrolmaterials,thetraceabilityofvaluesassignedtosuchcalibratorsand/orcontrolmaterialsshouldbeassuredthroughaqualitymanagementsystem。Anymeasurement,monitoringordisplayscaleshouldbedesignedinlinewithergonomicprinciples,takingaccountoftheintendedpurposeofthedevice.Whereverpossiblevaluesexpressednumericallyshouldbeincommonlyaccepted,standardisedunits,andunderstoodbytheusersofthedevice.Note:WhileSG1generallysupportsconvergenceontheglobaluseofinternationallystandardisedmeasurementunits,considerationsofsafety,userfamiliarity,andestablishedclinicalpracticemayjustifytheuseofotherrecognisedmeasurementunits。ProtectionagainstradiationGeneralDevicesshouldbedesignedandmanufacturedandpackagedinsuchawaythatexposureofpatients,usersandotherpersonstoanyemittedradiationshouldbereducedasfaraspracticableandappropriate,compatiblewiththeintendedpurpose,whilstnotrestrictingtheapplicationofappropriatespecifiedlevelsfortherapeuticanddiagnosticpurposes。5.11.2IntendedradiationWheredevicesaredesignedtoemithazardous,orpotentiallyhazardous,levelsofvisibleand/orinvisibleradiationnecessaryforaspecificmedicalpurposethebenefitofwhichisconsideredtooutweightherisksinherentintheemission,itshouldbepossiblefortheusertocontroltheemissions.Suchdevicesshouldbedesignedandmanufacturedtoensurereproducibilityofrelevantvariableparameterswithinanacceptabletolerance.Wheredevicesareintendedtoemitpotentiallyhazardous,visibleand/orinvisibleradiation,theyshouldbefitted,wherepracticable,withvisualdisplaysand/oraudiblewarningsofsuchemissions。UnintendedradiationDevicesshouldbedesignedandmanufacturedinsuchawaythatexposureofpatients,usersandotherpersonstotheemissionofunintended,strayorscatteredradiationisreducedasfaraspracticableandappropriate。InstructionsforuseTheoperatinginstructionsfordevicesemittingradiationshouldgivedetailedinformationastothenatureoftheemittedradiation,meansofprotectingthepatientandtheuserandonwaysofavoidingmisuseandofeliminatingtherisksinherentininstallation.IonizingradiationDevicesintendedtoemitionizingradiationshouldbedesignedandmanufacturedinsuchawayastoensurethat,wherepracticable,thequantity,geometryandenergydistribution(orquality)ofradiationemittedcanbevariedandcontrolledtakingintoaccounttheintendeduse。Devicesemittingionizingradiationintendedfordiagnosticradiologyshouldbedesignedandmanufacturedinsuchawayastoachieveappropriateimageand/oroutputqualityfortheintendedmedicalpurposewhilstminimisingradiationexposureofthepatientanduser。Devicesemittingionizingradiation,intendedfortherapeuticradiologyshouldbedesignedandmanufacturedinsuchawayastoenablereliablemonitoringandcontrolofthedelivereddose,thebeamtypeandenergyandwhereappropriatetheenergydistributionoftheradiationbeam.RequirementsformedicaldevicesconnectedtoorequippedwithanenergysourceDevicesincorporatingelectronicprogrammablesystems,includingsoftware,shouldbedesignedtoensuretherepeatability,reliabilityandperformanceofthesesystemsaccordingtotheintendeduse.Intheeventofasinglefaultconditioninthesystem,appropriatemeansshouldbeadoptedtoeliminateorreduceasfaraspracticableandappropriateconsequentrisks.Deviceswherethesafetyofthepatientsdependsonaninternalpowersupplyshouldbeequippedwithameansofdeterminingthestateofthepowersupply.Deviceswherethesafetyofthepatientsdependsonanexternalpowersupplyshouldincludeanalarmsystemtosignalanypowerfailure。Devicesintendedtomonitoroneormoreclinicalparametersofapatientshouldbeequippedwithappropriatealarmsystemstoalerttheuserofsituationswhichcouldleadtodeathorseveredeteriorationofthepatient'sstateofhealthDevicesshouldbedesignedandmanufacturedinsuchawayastoreduceasfaraspracticableandappropriatetherisksofcreatingelectromagneticinterferencewhichcouldimpairtheoperationofthisorotherdevicesorequipmentintheusualenvironment。Devicesshouldbedesignedandmanufacturedinsuchawayastoprovideanadequatelevelofintrinsicimmunitytoelectromagneticdisturbancetoenablethemtooperateasintended.ProtectionagainstelectricalrisksDevicesshouldbedesignedandmanufacturedinsuchawayastoavoid,asfaraspossible,theriskofaccidentalelectricshocksduringnormaluseandinsinglefaultcondition,providedthedevicesareinstalledandmaintainedasindicatedbythemanufacturer。ProtectionagainstmechanicalrisksDevicesshouldbedesignedandmanufacturedinsuchawayastoprotectthepatientanduseragainstmechanicalrisksconnectedwith,forexample,resistancetomovement,instabilityandmovingparts.Devicesshouldbedesignedandmanufacturedinsuchawayastoreducetothelowestpracticableleveltherisksarisingfromvibrationgeneratedbythedevices,takingaccountoftechnicalprogressandofthemeansavailableforlimitingvibrations,particularlyatsource,unlessthevibrationsarepartofthespecifiedperformance.Devicesshouldbedesignedandmanufacturedinsuchawayastoreducetothelowestpracticableleveltherisksarisingfromthenoiseemitted,takingaccountoftechnicalprogressandofthemeansavailabletoreducenoise,particularlyatsource,unlessthenoiseemittedispartofthespecifiedperformance。Terminalsandconnectorstotheelectricity,gasorhydraulicandpneumaticenergysupplieswhichtheuserhastohandleshouldbedesignedandconstructedinsuchawayastominimizeallpossiblerisks.Accessiblepartsofthedevices(excludingthepartsorareasintendedtosupplyheatorreachgiventemperatures)andtheirsurroundingsshouldnotattainpotentiallydangeroustemperaturesundernormaluse。Protectionagainsttherisksposedtothepatien

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