IEC 60601-2-24-2012 Medical electrical equipment - Part 2-24 Particular requirements for the safety of infusion pumps and controllers《医用电气设备.第2-24部分 输液泵及其控制器的安全性详细要求》.pdf

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

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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

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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