1、 IEC 60601-2-41Edition 2.0 2009-08INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis Appareils lectromdicaux Partie 2-41: Exigences particulires
2、pour la scurit de base et les performances essentielles des clairages chirurgicaux et des clairages de diagnostic IEC60601-2-41:2009 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2009 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be rep
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17、 electrical equipment Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis Appareils lectromdicaux Partie 2-41: Exigences particulires pour la scurit de base et les performances essentielles des clairages chirurgicaux e
18、t des clairages de diagnostic INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE WICS 11.040.20; 11.040.55; 11.040.99 PRICE CODECODE PRIXISBN 2-8318-1054-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotec
19、hnique Internationale 2 60601-2-41 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 201.1 Scope, object and related standards7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements12 201.5 General requirements for testing of ME EQUIPMENT .13 201.6 Classification of ME EQUI
20、PMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT Identification, marking and documents.14 201.8 Protection against electrical HAZARDS from ME EQUIPMENT15 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS .15 201.10 Protection against unwanted and excessive radiation HAZARDS 18 201
21、.11 Protection against excessive temperatures and other HAZARDS 18 201.12 Accuracy of controls and instruments and protection against hazardous outputs 19 201.13 HAZARDOUS SITUATIONS and fault conditions .33 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)33 201.15 Construction of ME EQUIPMENT
22、.33 201.16 ME SYSTEMS .33 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS33 Annex AA (informative) Guidance and rationale for particular clauses and subclauses.35 Bibliography38 Index of defined terms 39 Figure 201.101 Example of power supplies for SURGICAL LUMINAIRES 10 Figure 2
23、01.102 DETACHABLE HANDLE attachment and detachment tests.16 Figure 201.103 Test for ease of motion17 Figure 201.104 Light distribution22 Figure 201.105 CENTRAL ILLUMINANCE measurement.24 Figure 201.106 Measurements of LIGHT FIELD DIAMETER and diameter at 50 % of CENTRAL ILLUMINANCE 24 Figure 201.107
24、 Illuminance measurement with one mask.25 Figure 201.108 Illuminance measurement with two masks .25 Figure 201.109 Illuminance measurement with four different positions of the two masks.26 Figure 201.110 Tube for illuminance measurement 27 Figure 201.111 Detail of the inner surface of the tube (exam
25、ple) .27 Figure 201.112 Illuminance measurement at the bottom of a cavity, with one mask .28 Figure 201.113 Illuminance measurement at the bottom of a cavity, with two masks 29 Figure 201.114 Illuminance measurement at the bottom of a cavity, with four different positions of the two masks30 Figure 2
26、01.115 Measurement of DEPTH OF ILLUMINATION .31 Figure AA.1 Changeover cycle to an emergency backup system 36 60601-2-41 IEC:2009 3 Table 201.101 Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS12 Table 201.102 Distributed ESSENTIAL PERFORMANCE requirements 13 Table 201.103 Allowab
27、le maximum temperatures for ME EQUIPMENT parts that are likely to be touched.19 4 60601-2-41 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for d
28、iagnosis 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 concerning standardizati
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37、 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 subject of patent rights. IEC shall not be held responsible for identifying
38、 any or all such patent rights. International standard IEC 60601-2-41 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 2000. This edition c
39、onstitutes a technical revision to be consistent with the third edition of the IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/773/FDIS 62D/787/RVD Full information on the voting for the approval of this particular standard can be foun
40、d in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 60601-2-41 IEC:2009 5 In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informa
41、tive material appearing 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 st
42、andard, the term “clause” 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). Refer
43、ences to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular 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 con
44、ditions is true. The verbal 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”
45、means that compliance with 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
46、 or table title indicates 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. The committee has decided that the contents of this publicatio
47、n 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. 6 60601-2-41 IEC:2009 INTROD
48、UCTION This particular standard concerns the basic safety and essential performance of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS. It amends and supplements IEC 60601-1 (third Edition 2005), hereinafter referred to as the general standard. The requirements of this particular standard take prio
49、rity over those of the general standard, entitled “Medical electrical equipment Part 1: General requirements for basic safety and essential performance. 60601-2-41 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis 201.1 Scope, object and re
