IEC 60601-2-50-2009 Medical electrical equipment - Part 2-50 Particular requirements for the basic safety and essential performance of infant phototherapy equip.pdf

1、 IEC 60601-2-50Edition 2.0 2009-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment Appareils lectromdicaux Partie 2-50: Exigences particulires pour la scurit de b

2、ase et les performances essentielles des appareils de photothrapie pour nouveau-ns IEC60601-2-50:2009 THIS 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

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16、r des commentaires 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 60601-2-50Edition 2.0 2009-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-50

17、 Particular requirements for the basic safety and essential performance of infant phototherapy equipment Appareils lectromdicaux Partie 2-50: Exigences particulires pour la scurit de base et les performances essentielles des appareils de photothrapie pour nouveau-ns INTERNATIONAL ELECTROTECHNICAL C

18、OMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE UICS 11.040.60 PRICE CODECODE PRIXISBN 2-8318-1034-3 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-2-50 IEC:2009 CONTENTS FOREWORD.3 INTRODUCTION.6 201.1

19、 Scope, object and related standards .7 201.2 Normative references 9 201.3 Terms and definitions9 201.4 General requirements10 201.5 General requirements for testing of ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents11 2

20、01.8 Protection against electrical HAZARDS from ME EQUIPMENT14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS14 201.10 Protection against unwanted and excessive radiation HAZARDS15 201.11 Protection against excessive temperatures and other HAZARDS16 201.12 Accuracy of con

21、trols and instruments and protection against hazardous outputs16 201.13 HAZARDOUS SITUATIONS and fault conditions.19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19 201.15 Construction of ME EQUIPMENT .19 201.16 ME SYSTEMS 20 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYST

22、EMS .20 202 Electromagnetic compatibility .20 Annexes .20 Annex AA (informative) Particular guidance and rationale21 Bibliography26 Index of defined terms used in this particular standard28 Figure 201.101 Example of a measuring grid .17 Figure 201.102 Layout of weight test devices.19 Table 201.101 L

23、ist of symbols, abbreviations and acronyms 10 Table AA.1 UV radiation exposure limits and spectral weighting function .24 60601-2-50 IEC:2009 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-50: Particular requirements for the basic safety and essential performance o

24、f infant phototherapy 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 promote international co-operation on all questions c

25、oncerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”).

26、Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborate

27、s 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 opinion on the

28、relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that

29、the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the max

30、imum 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 rendered responsib

31、le 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 technical c

32、ommittees 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 other IEC Public

33、ations. 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 subject of p

34、atent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-50 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels a

35、nd replaces the first edition published in 2000. This edition constitutes a technical revision. Specific technical changes from the previous edition of this particular standard include: requiring graphical representation of the spectral irradiance in the instructions for use (this was previously opt

36、ional; see 201.7.9.2.5 b); requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101); requiring restoration of any preset values upon interruption and restoration of the power supply, if applicable (see 201.11.8); and corrections to the first four exposure limits (ELs) listed

37、in Table AA.1. 4 60601-2-50 IEC:2009 Minor changes from the previous edition of this particular standard include replacing the figure containing the eye protection symbol with a reference to this same symbol in IEC 60878 (see 201.7.2.101), defining an INFANT (see 201.3.202) and clarifying the titles

38、 for subclauses 201.5.4.102 and 201.5.4.103. The main purpose of this new edition, however, is to provide consistency with the third edition of the general standard. This edition further provides consistency with the four other particular standards related to pediatric equipment for which the commit

39、tee is responsible. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/736A/FDIS 62D/765/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. This publicatio

40、n 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 outside of tables, such as notes, examples and references: in smaller

41、 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” means one of the seventeen numbered divisions within the table of c

42、ontents, 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 this standard are preceded by the term “Clause” followed by the claus

43、e 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 conditions is true. The verbal forms used in this standard conform to usage described in Annex H

44、 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 with a requirement or a test is recommended but is not mandatory for co

45、mpliance 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 indicates that there is guidance or rationale related to that item in Annex A

46、A. 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. 60601-2-50 IEC:2009 5 The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on

47、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 60601-2-50 IEC:2009 INTRODUCTION The minimum safety requirements specified in this particular sta

48、ndard are considered to provide for a practical degree of safety in the operation of INFANT PHOTOTHERAPY EQUIPMENT. This particular standard amends and supplements IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance, hereinafter refe

49、rred to as the general standard. The requirements are followed by specifications for the relevant tests. A general guidance and rationale for the requirements of this particular standard are given in Annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of this particular standard but will, in due course, expedite a