IEC 60601-2-26-2012 Medical electrical equipment - Part 2-26 Particular requirements for the basic safety and essential performance of electroencephalographs《医用电气设备.第2-26部分 脑电图机基本安全性和必要性能的详细要求》.pdf
《IEC 60601-2-26-2012 Medical electrical equipment - Part 2-26 Particular requirements for the basic safety and essential performance of electroencephalographs《医用电气设备.第2-26部分 脑电图机基本安全性和必要性能的详细要求》.pdf》由会员分享,可在线阅读,更多相关《IEC 60601-2-26-2012 Medical electrical equipment - Part 2-26 Particular requirements for the basic safety and essential performance of electroencephalographs《医用电气设备.第2-26部分 脑电图机基本安全性和必要性能的详细要求》.pdf(62页珍藏版)》请在麦多课文档分享上搜索。
1、 IEC 60601-2-26 Edition 3.0 2012-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs Appareils lectromdicaux Partie 2-26: Exigences particulires pour la scurit de base
2、et les performances essentielles des lectroencphalographes IEC 60601-2-26:2012 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elect
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16、actez-nous: csciec.ch. IEC 60601-2-26 Edition 3.0 2012-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs Appareils lectromdicaux Partie 2-26: Exigences particulires p
17、our la scurit de base et les performances essentielles des lectroencphalographes INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE U ICS 11.040.55; 11.040.99 PRICE CODE CODE PRIX ISBN 978-2-83220-117-6 Registered trademark of the International Electrotechnical Comm
18、ission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-2-26 IEC:2012 CONTENTS FOREWORD . 3 INTR
19、ODUCTION . 5 201.1 Scope, object and related standards . 6 201.2 Normative references 8 201.3 Terms and definitions 8 201.4 General requirements 9 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 10 201.7 ME EQUIPMENT identification, mar
20、king and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiation HAZARDS 17 201.11 Protection against excessive temperatures and other HAZARD
21、S 17 201.12 Accuracy of controls and instruments and protection against hazardous outputs 18 201.13 HAZARDOUS SITUATIONS and fault conditions . 23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23 201.15 Construction of ME EQUIPMENT . 23 201.16 ME SYSTEMS 23 201.17 ELECTROMAGNETIC COMPATIBI
22、LITY of ME EQUIPMENT and ME SYSTEMS . 23 202 ELECTROMAGNETIC COMPATIBILITY Requirements and tests 23 Annexes . 26 Annex AA (informative) Particular guidance and rationale 27 Index of defined terms used in this particular standard 29 Figure 201.101 Test of protection against the effects of defibrilla
23、tion (common mode) . 14 Figure 201.102 Test of protection against the effects of defibrillation (differential mode) . 15 Figure 201.103 Application of the test voltage between LEAD WIRES to test the energy delivered by the defibrillator 16 Figure 201.104 General test circuit 20 Figure 201.105 Test c
24、ircuit for COMMON MODE REJECTION 22 Figure 202.101 Test layout for radiated and conducted EMISSION test and radiated immunity test 24 Figure 202.102 Set-up for radiated immunity test according to 202.6.2.3.2 25 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 10 60601-2-26 IEC:2012 3 INT
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