BS EN 60601-2-24-2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers《医疗电气设备 输液泵和控制器基本安全和基本性能的.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllersBS EN 60601-2-24:2015National forewordThis British Standard is the UK implementation of EN 60601-2-24:2015. It isidentical to IEC 60

2、601-2-24:2012. It supersedes BS EN 60601-2-24:1998,which will be withdrawn on 14 April 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical equipment.A list of organizations represente

3、d on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 62078

4、 2ICS 11.040.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 6

5、0601-2-24:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-24 May 2015 ICS 11.040.20 Supersedes EN 60601-2-24:1998 English Version Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (IEC 6

6、0601-2-24:2012) Appareils lectromdicaux - Partie 2-24: Exigences particulires pour la scurit de base et les performances essentielles des pompes et rgulateurs de perfusion (IEC 60601-2-24:2012) Medizinische elektrische Gerte - Teil 2-24: Besondere Festlegungen fr die Sicherheit einschlielich der wes

7、entlichen Leistungsmerkmale von Infusionspumpen und Infusionsreglern (IEC 60601-2-24:2012) This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the

8、status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, Fr

9、ench, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austri

10、a, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

11、 Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of ex

12、ploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-2-24:2015 E BS EN 60601-2-24:2015EN 60601-2-24:2015 2 Foreword The text of document 62D/1026/FDIS, future edition 2 of IEC 60601-2-24, prepared by SC 62D “Electromedical equipment“, of IEC/TC 62 “Electr

13、ical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-24:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsemen

14、t (dop) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-04-14 This document supersedes EN 60601-2-24:1998. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELE

15、C and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship

16、with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 60601-2-24:2012 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the fol

17、lowing note has to be added for the standard indicated : IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2. BS EN 60601-2-24:2015EN 60601-2-24:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole o

18、r in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 When an International Publication h

19、as been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Ti

20、tle EN/HD Year Replacement in Annex ZA of EN 60601-1:2006: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 - - + corrigend

21、um Mar. 2010 IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 2010 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential

22、performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 2007 - - + corrigendum Mar. 2010 Addition to Annex ZA of EN 60601-1:2006: IEC 60601-1 2005 Medical electrical equipment - Part 1:

23、General requirements for basic safety and essential performance EN 60601-1 2006 - - + corrigendum Mar. 2010 + A1 2012 + A1 2013 - - + A1/AC 2014 - - + A12 2014 ISO 3696 1987 Water for analytical laboratory use - Specification and test methods EN ISO 3696 1995 ISO 7864 - Sterile hypodermic needles fo

24、r single use EN ISO 7864 - ISO 8536-4 - Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed EN ISO 8536-4 - BS EN 60601-2-24:2015EN 60601-2-24:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepare

25、d under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard pro

26、vides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-24:2015 2 60601-2-24 IEC:2012 CONTENTS FOREWORD . 4 INTRODUC

27、TION . 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 EQUIPMENT identification, markin

28、g 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 temperatures and other HAZARDS 1

29、6 201.12 *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 37 201.17 Electromagnetic compatibili

30、ty 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 AA (informative) Particular guidan

31、ce 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 SYRINGE OR CONTAINER PUMPS . 23 Fig

32、ure 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 . 24 Figure 201.107 Trumpet curv

33、e 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 BS EN 60601-2-24:201560601-2-24 IEC:2012 3 Figure

34、 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 BOLUS volumes 33

35、 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 windows 56 Fi

36、gure 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 priorities and relat

37、ed situations 39 Table 208.102 * Characteristics of the PULSE of auditory ALARM SIGNALS . 40 BS EN 60601-2-24:2015 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 infus

38、ion pumps 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 concern

39、ing 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)”). Their

40、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 collaborates clos

41、ely 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 releva

42、nt 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 the te

43、chnical 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 maximum e

44、xtent 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 itself does not provide any attestation of conformity. Independent certification bodies provi

45、de conformity 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 i

46、ts directors, 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

47、 arising out 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) Attentio

48、n 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 any or all such patent rights. International standard IEC 60601-2-24 has been prepared by IEC subcommittee 62D: Electromedical equipm

49、ent, of IEC 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 alarms. 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 f