IEC naterial IEC62353 licensedtoBR Edition2.02014-09 INTERNATIONAL STANDARD Reuters NORME (Scientific). INTERNATIONALE Inc. colour inside Medicalelectricalequipment-Recurrenttestandtestafterrepairofmedical electrical equipment Appareilsélectromedicaux-Essairecurrentetessaiapresreparationd'un appareilélectromedical on -2014by Nofurther INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE PRICECODE XB CODEPRIX is ICS 11.040 ISBN978-2-8322-1847-1 per Warning!Makesurethatyou obtained thispublication froman authorized distributor. Attention!Veuillezvousassurerquevousavezobtenucettepublicationviaundistributeuragree. material - 2 - IEC62353:2014IEC2014 lice CONTENTS ensedto FOREWORD. 5 BR RDemo 1 Scope. 2 Normative references ..8 3 Terms and definitions. ..8 Thomson 4 Requirements.. 4.1 *Generalrequirements.. 4.2 TestingbeforePUTTING INTO SERVICE,afterMODIFICATIONS,and afterREPAIR.......17 4.3 *RECURRENTTEST.. .18 (Sci 5 *Tests. .18 5.1 General. 5.2 VisualINSPECTION Inc. 5.3 Measurements. 5.3.1 General.. 19 5.3.2 MeaSuringofPROTECTIVEEARTHRESISTANCE 5.3.3 *Measurement of insulation resistance (notmandatory) .21 5.3.4 Leakage currents ist 5.4 Functional test.. 6 Resultsoftestandevaluation. .31 6.1 Reporting of results. 6.2 Evaluation...... AnnexA(informative)General guidanceandrationale. ...33 oaded A.1 Intendedaudience on A.2 DifferencesbetweenIEC60601-1andIEC62353. Noy A.3 Rationale. ...35 -27 AnnexB(informative)Sequenceoftesting -2014by AnnexC(normative)Requirementsforthemeasurementequipmentandfor measurementcircuitsforPROTEcTIVEEARTHRESISTANCEandleakagecurrents.. .44 C.1 Requirementsforthemeasurement equipment. C.2 MeasurementequipmentformeaSurementofPROTEcTIVEEARTHRESISTANCE......44 C.3 Measurementequipmentformeasurementsof EQUIPMENTLEAKAGEcURRENT......45 C.4 MeasurementequipmentformeasurementsofAPPLIEDPARTLEAKAGE No CURRENT 45 AnnexD(informative)PATIENTENVIRONMENT ...47 AnnexE(normative)AllowablevaluesforleakagecurrentsfromIEC60601-1 ...48 AnnexF(informative)Testing intervals. ..51 odi AnnexG(informative)Exampleoftestdocumentation AnnexH(informative)NotesontestingMESYsTEMS.. .53 H.1 Overview .53 H.2 Guidelinesforre-testing ofanMESYSTEM.... ...53 H.3 GuidelinesonMESYsTEMsfromtherationaleannexofIEC60601- 1:2005/AMD1:2012. H.4 ExamplesofapplicationofMULTIPLESOCKET-OUTLETS (MSO) Bibliography. ..60 Indexofdefinedterms .61 3 - IEC62353:2014IEC2014 Figure1-Measuringcircuitforthemeasurementof PROTEcTIVEEARTHRESISTANCEin MEEQUIPMENTthatisdisconnectedfromtheSUPPLYMAINS... Figure2-MeasuringcircuitforthemeasurementofPROTECTIVEEARTHRESISTANCEin BR MEEQUiPMENTorMEsYsTEMS.whichforfunctionalreasonscannotbedisconnected fromtheSUPPLYMAINS,orinMEEQUIPMENTorMESYSTEMSpermanentlyconnectedto theSUPPLYMAINS. .20 no Figure3-Measuringcircuitforthemeasurementoftheinsulationresistancebetween MAINSPARTandprotectiveearthforCLASSIMEEQUIPMENTandbetweenMAINSPARTand (nOn-earthed)ACCESSIBLECONDUCTIVEPARTSforCLASSIandCLASSIIMEEQUIPMENT... 22 Figure4-Measuringcircuitformeasurementof theinsulationresistancebetween MAINSPARTandAPPLIEDPARTSwhichmakeapatientconnectionforCLASsIorCLASSIl ME EQUIPMENT......... Figure5-Measuringcircuitformeasurementofthe insulationresistancebetweenF- TYPEAPPLIEDPARTSwhichmakeapatientconnectionandprotectiveearthforCLASSI MEEQUIPMENTandbetweenF-TYPEAPPLIEDPARTSwhichmakeapatientconnectionand (non-earthed)ACCESSIBLECONDUCTIVEPARTSforCLASSIandCLASS IIMEEQUIPMENT.........23 Figure6-MeasuringcircuitforthemeasurementofMEEQuiPMENTleakagecurrent- alternativemethod ..26 Figure7-Measuring circuit forthe measurementof EQUIPMENT LEAKAGECURRENT- direct method.. .27 Figure8-MeasuringcircuitforthemeasurementEQUIPMENTLEAKAGECURRENT- differentialmethod. .28 Figure9-MeasuringcircuitforthemeasurementofAPPLIEDPARTLEAKAGECURRENT"F- TYPEAPPLIEDPART"-alternativemethod.. Figure1O-MeasuringcircuitforthemeasurementofAPPLIEDPARTLEAKAGECURRENT- MAINSVOLTAGEonF-TYPEAPPLIEDPART-directmethod Figure11-MeasuringcircuitforthemeasurementofAPPLI