1、 IEC 60601-2-18Edition 3.0 2009-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment Appareils lectromdicaux Partie 2-18: Exigences particulires pour la scurit de base et le
2、s performances essentielles des appareils dendoscopie IEC60601-2-18:2009 colourinsideTHIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 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,
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16、s sur cette publication ou si vous avez des questions, visitez le FAQ du Service clients ou contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-2-18Edition 3.0 2009-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-18: Particular requ
17、irements for the basic safety and essential performance of endoscopic equipment Appareils lectromdicaux Partie 2-18: Exigences particulires pour la scurit de base et les performances essentielles des appareils dendoscopie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNAT
18、IONALE XICS 11.040.50 PRICE CODECODE PRIXISBN 2-8318-1056-0 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale colourinside 2 60601-2-18 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 201.1 Scope, object and related standa
19、rds .8 201.2 Normative references 9 201.3 Terms and definitions10 201.4 General requirements12 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 documents14 201.8 Protection against electric
20、al HAZARDS from ME EQUIPMENT18 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS19 201.10 Protection against unwanted and excessive radiation HAZARDS20 201.11 Protection against excessive temperatures and other HAZARDS21 201.12 Accuracy of controls and instruments and protec
21、tion against hazardous outputs24 201.13 HAZARDOUS SITUATIONS and fault conditions.25 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .25 201.15 Construction of ME EQUIPMENT .25 201.16 ME SYSTEMS 26 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .26 202 Electromagnetic comp
22、atibility Requirements and tests .26 Annexes .27 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS27 Annex D (informative) Symbols on marking29 Annex J (informative) Survey of insulation paths31 Annex AA (informative) Particular guidance and rationale3
23、3 Annex BB (informative) Clauses of this standard addressing essential principles of safety and performance of medical devices (GHTF/SG1/N41R9:2005)43 Index of defined terms used in this particular standard45 Figure 201.101 Identification of LIGHT EMISSION PART 12 Figure 201.102 Measurement of CAPAC
24、ITIVELY-COUPLED HF CURRENT from conductive parts of an ENDOSCOPE24 Figure 201.J.101 Insulation example 101 .31 Figure 201.J.102 Insulation example 102 .32 Figure 201.J.103 Insulation example 103 .32 Figure AA.101 Illustration of typical CONFIGURATION FOR ENDOSCOPIC APPLICATION 34 Table 201.101 List
25、of ESSENTIAL PERFORMANCE requirements .13 60601-2-18 IEC:2009 3 Table 201.C.101 Marking on the outside of ENDOSCOPIC EQUIPMENT or its parts 27 Table 201.C.102 Marking on the inside of ENDOSCOPIC EQUIPMENT or its parts 27 Table 201.C.104 ACCOMPANYING DOCUMENTS, general 28 Table 201.C.105 ACCOMPANYING
26、 DOCUMENTS, instructions for use 28 Table 201.D.101 Symbols for marking ENDOSCOPIC EQUIPMENT or its parts29 Table BB.1 Correspondence between this standard and GHTF/SG1/N41R9:2005 43 4 60601-2-18 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-18: Particular
27、requirements for the basic safety and essential performance of endoscopic equipment 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 p
28、romote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, and Guides (hereafter referred to as “IEC Public
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30、 collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opi
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33、y to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be render
34、ed responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its
35、 technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any othe
36、r IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the
37、subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-18 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62, Electrical equipment in medical practice. This third ed
38、ition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: a) alignment of requirements with IEC 6
39、0601-1:2005; b) inclusion of essential performance requirements; c) the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; d) reference to IEC 60601-2-2 for the dielectric strength testing of HF energized
40、 endotherapy devices, rather than defining different tests. 60601-2-18 IEC:2009 5 The text of this particular standard is based on the following documents: Enquiry draft Report on voting 62D/682/CDV 62D/743/RVC Full information on the voting for the approval of this particular standard can be found
41、in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing
42、outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause
43、” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within
44、this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this collateral standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The ver
45、bal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance wi
46、th a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicate
47、s that there is guidance or rationale related to that item in Annex AA. A list of all parts of the IEC 60601 series, published under the general title: Medical electrical equipment, can be found on the IEC website. 6 60601-2-18 IEC:2009 The committee has decided that the contents of this publication
48、 will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. IMPORTANT The “colour inside”
49、 logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this publication using a colour printer. 60601-2-18 IEC:2009 7 INTRODUCTION The minimum safety requirements specified in this particular standard are considered to provide for a practical
