LEC IEC60601-2-47 Edition2.0 2012-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medicalelectricalequipment- Part2-47:Particularrequirementsforthebasicsafetyandessential performance ofambulatoryelectrocardiographicsystems Appareilselectromedicaux Partie2-47:Exigencesparticulierespourlasecuritedebaseetlesperformances essentiellesdessystemesd'électrocardiographieambulatoires IEC 60601-2-47:2012 IEC IEC60601-2-47 licensed Edition2.02012-02 toBR INTERNATIONAL STANDARD Reuters NORME INTERNATIONALE Medicalelectricalequipment- Part2-47:Particularrequirementsforthebasicsafetyandessentialperformance ofambulatoryelectrocardiographicsystems Appareilsélectromedicaux on Partie2-47:Exigencesparticulierespourlasecuritedebaseetlesperformances Nov essentiellesdessystemesd'électrocardiographieambulatoires -28 -2014by Jam No INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE PRICECODE XB CODEPRIX ICS11.040.55 ISBN978-2-88912-911-9 Warning!Makesurethatyouobtained thispublication froman authorized distributor. Attention!Veuillezvousassurerquevousavezobtenucettepublicationviaundistributeuragree. 60601-2-47@IEC:2012 -2 - CONTENTS FOREWORD. BR INTRODUCTION.. 201.1 Scope,objectandrelated standards. 201.2 Normativereferences .9 201.3 Termsanddefinitions. 201.4 General requirements... 201.5 General requirements fortesting of ME EQUIPMENT. .12 201.6 ClassificationofMEEQUIPMENTandMESYSTEMS. .12 S 201.7 MEEQUiPMENTidentification,markinganddocuments.. ..12 201.8 ProtectionagainstelectricalHAZARDSfromMEEQUIPMENT.. 201.9 ProtectionagainstMECHANICALHAZARDS ofMEEQUIPMENT andMESYSTEMS. .14 201.10 Protection against unwanted and excessive radiation HAZARDs. .14 201.11 Protection against excessive temperatures and other HAZARDs 201.12 Accuracyofcontrolsandinstrumentsandprotectionagainsthazardous outputs... 201.13 HAZARDOUSSITUATIONSandfaultconditions ..38 201.14 PROGRAMMABLEELECTRICALMEDICALSYSTEMS(PEMS) ..38 201.15 ConstructionofMEEQUIPMENT .38 201.16 ME SYSTEMS. .39 201.17 ElectromagneticcompatibilityofMEEQUIPMENTandMESYSTEMS.. ...39 ded 202 Electromagneticcompatibility-Requirementsandtests ..40 ..42 Annexes. AnnexAA (informative)Particularguidance and rationale. .43 Bibliography. 64 Index of defined terms used inthis particular standard. Figure201.101-General testcircuit for201.12.4.4.. Figure201.102-Test signal for input dynamicrangetest accordingto201.12.4.4.101......30 Figure201.103-Testcircuitforcommonmoderejectionaccordingto201.12.4.4.103.......33 Figure 201.104-Test circuit for pacemaker pulse tolerance according to 201.12.4.4.109...... Figure202.101-Testset-upforconductiveemissiontestaccordingto202.6.1.1.2and radiated emissionand radiated immunity testaccordingto202.6.1.1.2and202.6.2.3.2.....41 Table201.101-DistributedadditionalESSENTIALPERFORMANCErequirements 11 Table201.102-LEADWIREcolourcodes Table201.103-Requirements forall arrhythmiaalgorithms.. Table201.104-Requirementsforalgorithmswithoptional capabilities... ..18 Table201.105-Beatlabelclassifications. .22 Table201.106-Exampleofnoisefloorcalculationresults Table201.107-ExampleofHRVtestresults .25 Table201.108-Runsensitivitysummarymatrix .25 Table201.109-Runpositivepredictivitysummarymatrix. .26