IEC IEC 60601-2-18 Edition 3.02009-08 INTERNATIONAL STANDARD NORME INTERNATIONALE colour nside Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment Appareils électromedicaux - Partie 2-18: Exigences particulieres pour la sécurite de base et les performances essentielles des appareils d'endoscopie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE PRICECODE X CODEPRIX ICS11.040.50 ISBN 2-8318-1056-0 ? Registered trademark of the International Elect Marque deposée de la Commission Electrotechnique Internationale 60601-2-18 @IEC:2009 CONTENTS FOREWORD 4 INTRODUCTION 6 201.1 Scope, object and related standards 8 201.2 Normativereferences .9 201.3 Terms and definitions.. .10 201.4 General requirements... .12 201.5 General requirementsfortesting ofMEEQUIPMENT. 14 :201.6 ClassificationofMEEQUIPMENTandMESYSTEMS. .14 201.7 MEEQUIPMENTidentification,markinganddocuments. .14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT.. 201.9 ProtectionagainstMECHANICALHAZARDSofMEEQUIPMENTandMESYSTEMS... ..19 201.10 Protection against unwanted and excessiveradiation HAzARDs. ..20 201.11 Protection against excessive temperatures and other HAZARDs. 201.12 Accuracy of controls and instruments and protection against hazardous .24 outputs.... 201.13 HAZARDOUSSITUATIONSandfaultconditions .25 201.14 PROGRAMMABLEELECTRICALMEDICALSYSTEMS(PEMS) ..25 201.15 ConstructionofMEEQUIPMENT. ..25 201.16 MESYSTEMS 201.17 ElectromagneticcompatibilityofMEEQUIPMENTandMESYSTEMS. .26 202 Electromagnetic compatibility - Requirements and tests .26 Annexes 27 AnnexC(informative)Guideto markingandlabellingrequirementsforMEEQuiPMENT andMESYSTEMS. .27 AnnexD(informative)Symbols onmarking. .29 Annex J (informative) Survey of insulation paths.. ..31 AnnexAA(informative)Particular guidanceand rationale. .33 Annex BB (informative) Clauses of this standard addressing essential principles of safety and performance ofmedical devices (GHTF/SG1/N41R9:2005). 43 Index of defined terms used in this particular standard. 45 Figure 201.101 - Identification of LIGHT EMISSION PART. 12 Figure201.102-MeasurementofCAPACITIVELY-COUPLEDHFCURRENT fromconductive parts of an ENDOscoPE. .24 Figure201.J.101-Insulation example101... .31 Figure201.J.102-Insulationexample102. .32 .32 Figure 201.J.103- Insulation example 103. Figure AA.1O1-ilustration of typical cONFIGURATION FOR ENDOSCOPIC APPLICATION. Table201.101- List of ESSENTIALPERFORMANCE requirements 13 60601-2-18 IEC:2009 - 2 CONTENTS FOREWORD INTRODUCTION. 201.1 Scope, object and related standards 8 201.2 Normative references 201.3 Terms and definitions 201.4 General requirements.. .12 201.5 General requirements for testing of ME EQUIPMENT.. .14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 14 201.7 ME EQUIPMENT identification, marking and documents... .14 201.8 Protection against electrical HAZARDs from ME EQUIPMENT... 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS..... 201.10 Protection against unwanted and excessive radiation HAZARDs.. ...20 201.11 Protection against excessive temperatures and other HAzARDs. ..21 201.12 Accuracy of controls and instruments and protection against hazardous outputs. .24 201.13 HAZARDOUs SITUATIONs and fault conditions.. 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ..25 201.15 Construction of ME EQUIPMENT 201.16 ME SYSTEMS ....26 201.17 Electromagnetic compatibilityof MEEQUIPMENT and ME SYsTEMS 202 Electromagnetic compatibility - Requirements and tests .26 Annexes Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS.... 27 Annex D (informative) Symbols on marking. 29 Annex J (informative) Survey of insulation paths. ..31 Annex AA (informative) Particular guidance and rationale.. ....33 Annex BB (informative) Clauses of this standard addressing essential principles of safety and performance of medica