1、 IEC 60601-2-24 Edition 2.0 2012-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers Appareils lectromdicaux Partie 2-24: Exigences particulires pour la scurit
2、de base et les performances essentielles des pompes et rgulateurs de perfusion IEC60601-2-24:2012 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or
3、by any means, electronic or mechanical, including 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 pu
4、blication, please contact the address below or your 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, lectroniq
5、ue ou mcanique, y compris la photocopie et les microfilms, 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
6、 ou contactez le Comit national de la CEI de votre pays de rsidence. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varemb 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 organizati
7、on that prepares and publishes International Standards for all electrical, electronic 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 m
8、ight have been published. Useful links: IEC publications search - www.iec.ch/searchpub The advanced search enables you to find IEC publications by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Jus
9、t Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available on-line and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms
10、 containing more than 30 000 terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary (IEV) on-line. Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication o
11、r need further assistance, please contact the Customer Service Centre: csciec.ch. 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 techn
12、ologies apparentes. A propos 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. Liens utiles: Recherche de publications CEI - www.iec.ch/searchpub L
13、a recherche avance vous permet de trouver des publications CEI en utilisant diffrents critres (numro de rfrence, texte, comit dtudes,). Elle donne aussi des informations sur les projets et les publications remplaces ou retires. Just Published CEI - webstore.iec.ch/justpublished Restez inform sur les
14、 nouvelles publications de la CEI. Just Published dtaille les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 30 000 termes
15、 et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement appel Vocabulaire Electrotechnique International (VEI) en ligne. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez
16、 des questions contactez-nous: csciec.ch. IEC 60601-2-24 Edition 2.0 2012-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers Appareils lectromdicaux Partie 2-2
17、4: Exigences particulires pour la scurit de base et les performances essentielles des pompes et rgulateurs de perfusion INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.20 PRICE CODE CODE PRIX ISBN 978-2-83220-417-7 Registered trademark of the Intern
18、ational Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-2-24 IEC:20
19、12 CONTENTS FOREWORD . 4 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 12 201.5 General requirements for testing of ME EQUIPMENT . 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 13 201.7 ME
20、 EQUIPMENT identification, marking and documents 13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 15 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 16 201.10 Protection against unwanted and excessive radiation HAZARDS 16 201.11 Protection against excessive
21、 temperatures and other HAZARDS 16 201.12 *Accuracy of controls and instruments and protection against hazardous outputs 17 201.13 HAZARDOUS SITUATIONS and fault conditions . 35 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 35 201.15 Construction of ME EQUIPMENT . 35 201.16 ME SYSTEMS 37 2
22、01.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37 202 Electromagnetic compatibility Requirements and tests . 37 206 Usability 38 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 38 Annexes . 42 Annex A
23、A (informative) Particular guidance and rationale 43 Bibliography 58 Index of defined terms used in this particular standard 59 Figure 201.103 Analysis periods 22 Figure 201.104a Test apparatus for VOLUMETRIC INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS 22 Figure 201.104b Test apparatus for SY
24、RINGE OR CONTAINER PUMPS . 23 Figure 201.104 Test apparatuses for different types of INFUSION PUMPS 23 Figure 201.105 Start-up graph plotted from data gathered during the first 2 h of the test period 23 Figure 201.106 Trumpet curve plotted from data gathered during the second hour of the test period
25、 . 24 Figure 201.107 Trumpet curve plotted from data gathered during the last hour of the ADMINISTRATION SET CHANGE INTERVAL 24 Figure 201.108 Start-up graph over the stabilization period . 25 Figure 201.109 Trumpet curve plotted from data at the end of the stabilization period . 25 60601-2-24 IEC:2
26、012 3 Figure 201.110 Start-up curve over the stabilization period for quasi-continuous output pumps 26 Figure 201.111 Trumpet curve plotted from data at the end of the stabilization period for quasi-continuous pumps 26 Figure 201.112 Test apparatus to determine the OCCLUSION ALARM THRESHOLD and BOLU
27、S volumes 33 Figure AA.101 Start-up graph 49 Figure AA.102 Trumpet curve 49 Figure AA.103 Calculation for Ep(max.) and Ep(min.) . 52 Figure AA.104 Sampling protocol . 53 Figure AA.105 Observation windows 54 Figure AA.106 Distribution of parent variate X 55 Figure AA.107 Distribution of observation w
28、indows 56 Figure AA.108 The statistical trumpet graph . 56 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 12 Table 201.102 Set rates, BOLUS volumes and test apparatus for the accuracy tests of 12.1.102 to 12.1.107 . 31 Table 202.101 Test levels 37 Table 208.101 ALARM CONDITION prioriti
29、es and related situations 39 Table 208.102 * Characteristics of the PULSE of auditory ALARM SIGNALS . 40 4 60601-2-24 IEC:2012 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps
30、and controllers 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 standa
31、rdization 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)”). Their preparatio
32、n 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 collaborates closely with t
33、he 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 relevant subject
34、s 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 the technical co
35、ntent 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 maximum extent poss
36、ible 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 itself does not provide any attestation of conformity. Independent certification bodies provide conform
37、ity assessment services and, in some areas, access to IEC marks of 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 directo
38、rs, employees, servants or agents including individual experts and 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 o
39、ut of the publication, use of, or reliance upon, this IEC Publication 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
40、 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 any or all such patent rights. International standard IEC 60601-2-24 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IE
41、C technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-24 published in 1998. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012 with new clause numbering, including usability and a
42、larms. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/1026/FDIS 62D/1039/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. 60601-2-24 IEC:2012 5 This
43、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 outside of tables, such as notes, examples and references:
44、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” means one of the seventeen numbered divisions within the
45、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 this standard are preceded by the term “Clause” followed by
46、 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 conditions is true. The verbal forms used in this standard conform to usage described
47、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 with a requirement or a test is recommended but is not mandat
48、ory 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 indicates that there is guidance or rationale related to that item
49、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 publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publ
