1、 IEC 60601-2-13Edition 3.1 2009-08INTERNATIONAL STANDARD Medical electrical equipment Part 2-13:Particular requirements for the safety and essential performance of anaesthetic systems IEC 60601-2-13:2003+A1:2006(E)LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUP
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9、+41 22 919 02 11 Fax:+41 22 919 03 00 LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.IEC 60601-2-13Edition 3.1 2009-08INTERNATIONAL STANDARD Medical electrical equipment Part 2-13:Particular requirements for the safety and essential
10、performance of anaesthetic systems INTERNATIONAL ELECTROTECHNICAL COMMISSION CJICS 11.040.10 PRICE CODEISBN 2-8318-1058-8 Registered trademark of the International Electrotechnical Commission LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY B
11、UREAU.2 60601-2-13 IEC:2003+A1:2006(E)CONTENTS FOREWORD.4 INTRODUCTION.6 SECTION ONE GENERAL 1 Scope and object.7 2 Terminology and definitions.10 3 General requirements.12 4 General requirements for tests.12 6 Identification,marking and documents.12 SECTION TWO ENVIRONMENTAL CONDITIONS 10 Environme
12、ntal conditions.17 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVE
13、N PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS*43 Fire prevention.18 44 Overflow,spillage,leakage,humidity,ingress of liquids,cleaning,sterilization and disinfection.19 49 Interruption of the POWER SUPPLY.19 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARD
14、OUS OUTPUT 51 Protection against hazardous output.20 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions.24 SECTION TEN CONSTRUCTIONAL REQUIREMENTS 54 General.24 56 Components and general assembly.24 57 MAINS PARTS,components and layout
15、.25 LICENSED TO MECON Limited.-RANCHI/BANGALORE,FOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.60601-2-13 IEC:2003+A1:2006(E)3 SECTION 101 ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS DELIVERY SYSTEMS 101 Medical gas supply.26 102 Medical gas pipeline inlet connections.26 10
16、3 Medical gas supply pressure monitoring.26 104 Medical gas supply PRESSURE REGULATORs.27 105 Anaesthetic gas delivery system piping.27 106 Gas flow metering.27 107 Gas mixer.29 108 Oxygen flush.29 109 Fresh gas outlet.30 110 Checklist.30 Annex AA (informative)Guidance and rationale for particular clauses and subclauses in this particular standard.31 Annex BB(informative)MONITORING DEVICES,ALARM SYSTEM(S)and PROTECTION DEVICES.35 Annex CC(informative)Separate devices of an ANAESTHETIC SYSTEM.36
