IEC 60601-2-46-2016 Medical electrical equipment - Part 2-46 Particular requirements for the basic safety and essential performance of operating tables《医用电气设备 第2-46部分 手术台基本安全性和必要性能的详细要求》.pdf
《IEC 60601-2-46-2016 Medical electrical equipment - Part 2-46 Particular requirements for the basic safety and essential performance of operating tables《医用电气设备 第2-46部分 手术台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 60601-2-46-2016 Medical electrical equipment - Part 2-46 Particular requirements for the basic safety and essential performance of operating tables《医用电气设备 第2-46部分 手术台基本安全性和必要性能的详细要求》.pdf(80页珍藏版)》请在麦多课文档分享上搜索。
1、 IEC 60601-2-46 Edition 3.0 2016-08 REDLINE VERSION Medical electrical equipment Part 2-46: Particular requirements for the basic safety and essential performance of operating tables IEC 60601-2-46:2016-08 RLV(en) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2016 IEC, Geneva, Swit
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4、b Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publ
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7、eference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available online and also on
8、ce a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing 20 000 terms and definitions in English and French, with equivalent terms in 15 additional languages. Also known as the International Electrotechnical Vocabular
9、y (IEV) online. IEC Glossary - std.iec.ch/glossary 65 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002. Some entries have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR. IEC C
10、ustomer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC 60601-2-46 Edition 3.0 2016-08 REDLINE VERSION Medical electrical equipment Part 2-46: Particular requirements
11、for the basic safety and essential performance of operating tables INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.140 ISBN 978-2-8322-3581-2 Registered trademark of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. c
12、olour inside 2 IEC 60601-2-46:2016 RLV IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 9 201.3 Terms and definitions 9 201.4 General requirements . 10 201.5 General requirements for testing ME EQUIPMENT OPERATING TABLES 10 201.
13、6 Classification of ME EQUIPMENT OPERATING TABLES and ME SYSTEMS 10 201.7 ME EQUIPMENT OPERATING TABLES identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT OPERATING TABLES . 11 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT OPERATING T
14、ABLES and ME SYSTEMS 11 201.10 Protection against unwanted and excessive radiation HAZARDS . 14 201.11 Protection against excessive temperatures and other HAZARDS . 14 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 15 201.13 HAZARDOUS SITUATIONS and fault cond
15、itions for OPERATING TABLES . 15 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15 201.15 Construction of ME EQUIPMENT OPERATING TABLES 15 201.16 ME SYSTEMS 15 201.17 Electromagnetic compatibility of ME EQUIPMENT OPERATING TABLES and ME SYSTEMS . 16 202 Electromagnetic compatibility disturb
16、ances Requirements and tests . 16 203 Radiation protection in diagnostic X-ray equipment 20 Annexes . 21 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures 22 Annex AA (informative) Particular guidance and rationale 23 Bibliography 25 Index of defined terms
17、used in this particular standard 26 Figure 202.101 ENCLOSURE ad hoc test 18 Figure 202.102 POWER SUPPLY CORD ad hoc test 19 Figure 202.103 ACCESSORy cable ad hoc test. 19 Figure AA.1 Recommended distribution of mass in excess of 135 kg and examples of application 23 Table 201.101 Determination of TE
18、NSILE SAFETY FACTOR . 13 Table AA.1 Recommended distribution of mass in excess of 135 kg and examples of application 24 IEC 60601-2-46:2016 RLV IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-46: Particular requirements for the basic safety and essential pe
19、rformance of operating tables FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions con
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