EN60601-1 check list

Manufacture:FookTinTechnologiesLtd.Device:MechanicalscalesEN60601-1checklistNo.Items4Generalrequirements4.2RISKMANAGEMENTPROCESSforMEEQUIPMENTorMESYSTEMS4.3ESSENTIALPERFORMANCE4.4EXPECTEDSERVICELIFE4.5EquivalentsafetyforMEEQUIPMENTorMESYSTEMS4.6MEEQUIPMENTorMESYSTEMpartsthatcontactthePATIENT4.7SINGLEFAULTCONDITIONforMEEQUIPMENT4.8ComponentsofMEEQUIPMENT4.9UseofCOMPONENTSWITHHIGH-INTEGRITYCHARACTERISTICSinMEEQUIPMENT4.10Powersupply4.10.1SourceofpowerforMEEQUIPMENT4.10.2SUPPLYMAINSforMEEQUIPMENTandMESYSTEMS4.11Powerinput7MEEQUIPMENTidentification,markinganddocuments7.1General7.1.1USABILITYoftheidentification,markinganddocuments7.1.2Legibilityofmarkings7.1.3Durabilityofmarkings7.2MarkingontheoutsideofMEEQUIPMENTorMEEQUIPMENTparts7.2.1MinimumrequirementsformarkingonMEEQUIPMENTandoninterchangeableparts7.2.2Identification7.2.3ConsultACCOMPANYINGDOCUMENTS7.2.4ACCESSORIES7.2.5MEEQUIPMENTintendedtoreceivepowerfromotherequipment7.2.6ConnectiontotheSUPPLYMAINS7.2.7ElectricalinputpowerfromtheSUPPLYMAINS7.2.8Outputconnectors7.2.8.1Mainspoweroutput7.2.8.2Otherpowersources7.2.9IPclassification7.2.10APPLIEDPARTS7.2.11Modeofoperation7.2.12Fuses7.2.13Physiologicaleffects(safetysignsandwarningstatements)7.2.14HIGHVOLTAGETERMINALDEVICES7.2.15Coolingconditions7.2.16Mechanicalstability7.2.17Protectivepackaging7.2.18Externalpressuresource7.2.19FUNCTIONALEARTHTERMINALS7.2.20Removableprotectivemeans7.3MarkingontheinsideofMEEQUIPMENTorMEEQUIPMENTparts7.3.1Heatingelementsorlampholders7.3.2HIGHVOLTAGEparts7.3.3Batteries7.3.4Fuses,THERMALCUT-OUTSandOVER-CURRENTRELEASES7.3.5PROTECTIVEEARTHTERMINALS7.3.6FUNCTIONALEARTHTERMINALS7.3.7Supplyterminals7.3.8Temperatureofsupplyterminals7.4Markingofcontrolsandinstruments7.4.1Powerswitches7.4.2Controldevices7.4.3Unitsofmeasure7.5Safetysigns7.6Symbols7.6.1ExplanationofsymbolsPage1of1626-11-10Manufacture:FookTinTechnologiesLtd.Device:MechanicalscalesEN60601-1checklistNo.Items7.6.2SymbolsfromAnnexD7.6.3Symbolsforcontrolsandperformance7.7Coloursoftheinsulationofconductors7.7.1PROTECTIVEEARTHCONDUCTOR7.7.2PROTECTIVEEARTHCONNECTIONS7.7.3Greenandyellowinsulation7.7.4Neutralconductor7.7.5POWERSUPPLYCORDconductors7.8Indicatorlightsandcontrols7.8.1Coloursofindicatorlights7.8.2Coloursofcontrols7.9ACCOMPANYINGDOCUMENTS7.9.1General7.9.2Instructionsforuse7.9.2.1General7.9.2.2Warningandsafetynotices7.9.2.3MEEQUIPMENTspecifiedforconnectiontoaseparatepowersupply7.9.2.4Electricalpowersource7.9.2.5MEEQUIPMENTdescription7.9.2.6Installation7.9.2.7IsolationfromtheSUPPLYMAINS7.9.2.8Start-upPROCEDURE7.9.2.9Operatinginstructions7.9.2.10Messages7.9.2.11ShutdownPROCEDURE7.9.2.12Cleaning,disinfectionandsterilization7.9.2.13Maintenance7.9.2.14ACCESSORIES,supplementaryequipment,usedmaterial7.9.2.15Environmentalprotection7.9.2.16Referencetothetechnicaldescription7.9.3Technicaldescription7.9.3.1General7.9.3.2Replacementoffuses,POWERSUPPLYCORDSandotherparts7.9.3.3Circuitdiagrams,componentpartlists,etc.7.9.3.4Mainsisolation8ProtectionagainstelectricalHAZARDSfromMEEQUIPMENT8.1Fundamentalruleofprotectionagainstelectricshock8.2Requirementsrelatedtopowersources8.2.1Connectiontoaseparatepowersource8.2.2Connectiontoanexternald.c.powersource8.3ClassificationofAPPLIEDPARTS8.4Limitationofvoltage,currentorenergy8.4.1PATIENTCONNECTIONSintendedtodelivercurrent8.4.2ACCESSIBLEPARTSincludingAPPLIEDPARTS8.4.3MEEQUIPMENTintendedtobeconnectedtoapowersourcebyaplug8.4.4Internalcapacitivecircuits8.5Separationofparts8.5.1MEANSOFPROTECTION(MOP)8.5.1.1General8.5.1.2MEANSOFPATIENTPROTECTION(MOPP)8.5.1.3MEANSOFOPERATORPROTECTION(MOOP)8.5.2SeparationofPATIENTCONNECTIONS8.5.2.1F-TYPEAPPLIEDPARTS8.5.2.2TYPEBAPPLIEDPARTS8.5.2.3PATIENTleads8.5.3MAXIMUMMAINSVOLTAGE8.5.4WORKINGVOLTAGEPage2of1626-11-10Manufacture:FookTinTechnologiesLtd.Device:MechanicalscalesEN60601-1checklistNo.Items8.5.5DEFIBRILLATION-PROOFAPPLIEDPARTS8.5.5.1Defibrillationprotection8.5.5.2Energyreductiontest8.6Protectiveearthing,functionalearthingandpotentialequalizationofMEEQUIPMENT8.6.1Applicabilityofrequirements8.6.2PROTECTIVEEARTHTERMINAL8.6.3Protectiveearthingofmovingparts8.6.4Impedanceandcurrent-carryingcapability8.6.5Surfacecoatings8.6.6Plugsandsockets8.6.7POTENTIALEQUALIZATIONCONDUCTOR8.6.8FUNCTIONALEARTHTERMINAL8.6.9CLASSIIMEEQUIPMENT8.7LEAKAGECURRENTSandPATIENTAUXILIARYCURRENTS8.7.1Generalrequirements8.7.2SINGLEFAULTCONDITIONS8.7.3Allowablevalues8.7.4Measurements8.7.4.1General8.7.4.2Measuringsupplycircuits8.7.4.3Connectiontothemeasuringsupplycircuit8.7.4.4Measuringdevice(MD)8.7.4.5MeasurementoftheEARTHLEAKAGECURRENT8.7.4.6MeasurementoftheTOUCHCURRENT8.7.4.7MeasurementofthePATIENTLEAKAGECURRENT8.7.4.8MeasurementofthePATIENTAUXILIARYCURRENT8.7.4.9MEEQUIPMENTwithmultiplePATIENTCONNECTIONS8.8Insulation8.8.1General8.8.2Distancethroughsolidinsulationoruseofthinsheetmaterial8.8.3Dielectricstrength8.8.4Insulationotherthanwireinsulation8.8.4.1Mechanicalstrengthandresistancetoheat8.8.4.2Resistancetoenvironmentalstress8.9CREEPAGEDISTANCESandAIRCLEARANCES8.9.1Values8.9.1.1General8.9.1.2CREEPAGEDI