1、 IEC 60601-2-45 Edition 3.1 2015-06 CONSOLIDA TED V ER SION Medical electrical equipment Part 2-45:Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic dev ices IEC 60601-2-45:2011-02+AMD1:2015-06 CSV(en)colourinsideCopy
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11、:csciec.ch.Copyright International Electrotechnical Commission IEC 60601-2-45 Edit ion 3.1 2015-06 CONSOLIDA TED VERSION Medical electrical equipment Part 2-45:Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic dev ice
12、s INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.50 ISBN 978-2-8322-2761-9 R egist er ed tr ademar k of t he Int er national Electr ot echnical Commission Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideCopyright International Electrotechnical Co
13、mmission Copyright International Electrotechnical Commission IEC 60601-2-45 Edition 3.1 2015-06 REDLINE V ER SION Medical electrical equipment Part 2-45:Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic dev ices IEC 6
14、0000:2000-00+AMDX:2015-01 CSV(EN)colourinsideCopyright International Electrotechnical Commission 2 IEC 60601-2-45:2011 +AMD1:2015 CSV IEC 2015 CONTENTS FOREWORD.3 INTRODUCTION.6 INTRODUCTION to Amendment 1.6 201.1 Scope,object and related standards.7 201.2 Normative references.9 201.3 Terms and defi
15、nitions.10 201.4 General requirements.11 201.5 General requirements for testing of ME EQUIPMENT.12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.13 201.7 ME EQUIPMENT identification,marking and documents.13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT.17 201.9 Protection again
16、st MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.19 201.10 Protection against unwanted and excessive radiation HAZARDS.22 201.11 Protection against excessive temperatures and other HAZARDS.22 201.12 Accuracy of controls and instruments and protection against hazardous outputs.22 201.13 Hazardous situations and fault conditions for ME EQUIPMENT.23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS(PEMS).23 201.15 Construction of ME EQUIPMENT.23 201.16 ME SYSTEMS.23 201.17 Electromagnetic compatib
