1、 IEC 60601-2-52Edition 1.0 2009-12INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical beds Appareils lectromdicaux Partie 2-52: Exigences particulires de scurit de base et de performances
2、 essentielles des lits mdicaux IEC60601-2-52:2009 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 or by any means, electronic or mechanical, includin
3、g photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or y
4、our local IEC member National Committee for further information. Droits de reproduction rservs. Sauf indication contraire, aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd, lectronique ou mcanique, y compris la photocopie et les m
5、icrofilms, sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplmentaires sur cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de vot
6、re pays de rsidence. IEC Central Office 3, rue de Varemb CH-1211 Geneva 20 Switzerland Email: inmailiec.ch Web: 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, elec
7、tronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publications: www.iec.ch/searchpub T
8、he IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Pub
9、lished details twice a month all new publications released. Available on-line and also by email. Electropedia: www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French, with equivalent terms i
10、n additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: cs
11、ciec.ch Tel.: +41 22 919 02 11 Fax: +41 22 919 03 00 A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la premire organisation mondiale qui labore et publie des normes internationales pour tout ce qui a trait llectricit, llectronique et aux technologies apparentes. A propos
12、des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de
13、 la CEI vous permet deffectuer des recherches en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Il donne aussi des informations sur les projets et les publications retires ou remplaces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publicat
14、ions de la CEI. Just Published dtaille deux fois par mois les nouvelles publications parues. Disponible en-ligne et aussi par email. Electropedia: www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en a
15、nglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International en ligne. Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm Si vous dsirez nous donner des commentaires sur cette publication ou si vous
16、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 60601-2-52Edition 1.0 2009-12INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-52: Particular requirements for the basic safety and e
17、ssential performance of medical beds Appareils lectromdicaux Partie 2-52: Exigences particulires de scurit de base et de performances essentielles des lits mdicaux INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XCICS 11.140 PRICE CODECODE PRIXISBN 2-8318-1068-1
18、2 60601-2-52 IEC:2009 CONTENTS FOREWORD.5 INTRODUCTION.7 201.1 Scope, object and related standards .8 201.2 Normative references9 201.3 Terms and definitions10 201.4 General requirements .13 201.5 General requirements for testing of ME EQUIPMENT 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
19、15 201.7 ME EQUIPMENT identification, marking and documents .15 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .20 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .21 201.10 Protection against unwanted and excessive radiation HAZARDS .44 201.11 Protection ag
20、ainst excessive temperatures and other HAZARDS .44 201.12 Accuracy of controls and instruments and protection against hazardous outputs .46 201.13 HAZARDOUS SITUATIONS and fault conditions 47 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47 201.15 Construction of ME EQUIPMENT.48 201.16 ME SY
21、STEMS 51 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .51 Annexes .51 Annex AA (informative) Particular guidance and rationale52 Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS.67 Annex CC (informative) Particular guidance for assessing risk of en
22、trapment in v-shaped openings 75 Bibliography81 Index of defined terms used in this particular standard82 Figure 201.101 APPLIED PART10 Figure 201.102 MEDICAL BED, general arrangement (example, schematic presentation only) .12 Figure 201.103a Cone tool.14 Figure 201.103b Cylinder tool 14 Figure 201.
23、103 Entrapment test tools.14 Figure 201.104 Loading pad 15 Figure 201.105 Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD .16 Figure 201.106 MEDICAL BED function controls and/or actuators: guidelines for creating graphic symbols 18 Figure 201.107 Example of MEDICAL BED with segmented
24、 or split SIDE RAIL .22 Figure 201.108 Example of MEDICAL BED with single piece SIDE RAIL .23 Figure 201.109 Allowable spacing for fingers in areas of normal reach around the perimeter of the MATTRESS SUPPORT PLATFORM 28 60601-2-52 IEC:2009 3 Figure 201.110 Example using barriers for clearance measu
25、rement around the perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment 29 Figure 201.111a Foot and toe clearance area between moving parts and the floor.29 Figure 201.111b Toe clearance area between moving parts and the floor 30 Figure 201.111 Clearance areas 30 Figure 20
26、1.112 Lateral stability test along the side of the MEDICAL BED.32 Figure 201.113 Longitudinal stability test with removable FOOT BOARD .32 Figure 201.114 Longitudinal stability test with fixed HEAD/FOOT BOARDS33 Figure 201.115 Distribution of SAFE WORKING LOAD for tests37 Figure 201.116 Position of
27、loading pad (see Figure 201.104).40 Figure 201.117 Application of forces for test of SIDE RAIL42 Figure 201.118 Height of SIDE RAIL .43 Figure 201.119a Angle between the back section and the leg section of the MATTRESS SUPPORT PLATFORM49 Figure 201.119b Angle between the back section and the upper l
28、eg section of the MATTRESS SUPPORT PLATFORM49 Figure 201.119c Angle between the angled back section and upper leg section of the MATTRESS SUPPORT PLATFORM 49 Figure 201.119d Angle between the angled back section and the leg/upper leg section of the MATTRESS SUPPORT PLATFORM 50 Figure 201.119 Configu
29、rations of the MATTRESS SUPPORT PLATFORM .50 Figure AA.1 Marking to select recommended mattresses specified by the MANUFACTURER54 Figure AA.2 Marking for detachable SIDE RAILS specified by the MANUFACTURER .54 Figure AA.3 Resultant forces without mattress.58 Figure AA.4 Resultant forces with mattres
30、s58 Figure AA.5 Example of 60 mm gap measurement of B58 Figure AA.6 Angle measurement example of B 58 Figure AA.7 Placement of measurement TOOL for measurement of D .59 Figure AA.8 Example of area D measurement that passes .59 Figure AA.9 Example of area D measurement that fails59 Figure AA.10 Examp
31、le of area D measurement that fails (on limit) .60 Figure AA.11 Example of potential PATIENT entrapment in area A within the SIDE RAIL 60 Figure AA.12 Example of potential PATIENT entrapment in area A below the SIDE RAIL 60 Figure AA.13 Example of potential PATIENT entrapment in area B.60 Figure AA.
32、14 Example of potential PATIENT entrapment in area C between split SIDE RAIL 60 Figure AA.15 Example of potential PATIENT entrapment in area C between SIDE RAIL and HEAD BOARD 61 Figure AA.16 Example of potential PATIENT entrapment in area D.61 Figure AA.17 Example of potential PATIENT entrapment in
33、 area A below a single piece SIDE RAIL 61 Figure BB.1 Other areas of possible impact testing68 Figure BB.2 Impactor .69 Figure BB.3 Schematic presentation of under MEDICAL BED clearance.72 4 60601-2-52 IEC:2009 Figure BB.4 Recommendations and requirements regarding angles for different sections of t
34、he MATTRESS SUPPORT PLATFORM 74 Figure CC.1 Wedge tool.76 Figure CC.2 V-shaped opening in relation to B.77 Figure CC.3 Pass/fail in relation to area B .77 Figure CC.4 Positioning of wedge tool .78 Figure CC.5 Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD79 Figure CC.6 Pass/fail i
35、n relation to area C between split SIDE RAILS .80 Table 201.101 Protection against PATIENT entrapment .24 Table 201.102 Protection against inadvertent PATIENT falls 44 Table 24 Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED PARTS45 Table BB.1 Normative and informative requi
36、rements for different APPLICATION ENVIRONMENTS 1 to 5 .67 60601-2-52 IEC:2009 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-52: Particular requirements for the basic safety and essential performance of medical beds FOREWORD 1) The International Electrotechnical Co
37、mmission (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 standardization in the electrical and electronic fields. To this end an
38、d 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)”). Their preparation is entrusted to technical committees; any IEC National Committe
39、e 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 collaborates closely with the International Organization for Standardization (ISO) in accord
40、ance 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 relevant subjects since each technical committee has representation from all inte
41、rested 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 the technical content of IEC Publications is accurate, IEC cannot be held respons
42、ible 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 maximum extent possible in their national and regional publications. Any divergence
43、between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks o
44、f conformity. IEC is not responsible for any services carried out by independent certification bodies. 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 an
45、d members of its 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 Publica
46、tion or any other 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 Publica
47、tion may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-52 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practic
48、e, and by ISO technical committee 173: Assistive products for persons with disability. It is published as double logo standard. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. T
49、he text of this particular standard is based on the following documents: FDIS Report on voting 62D/795/FDIS 62D/815/RVD 6 60601-2-52 IEC:2009 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. In ISO, the standard has been approved
