1、 IEC 60601-2-34 Edition 3.0 2011-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment Appareils lectromdicaux Partie 2-34: Exigences particulires p
2、our la scurit de base et les performances essentielles des appareils de surveillance de la pression sanguine prleve directement IEC 60601-2-34:2011 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publica
3、tion may be reproduced or utilized in any form or 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 en
4、quiry about obtaining additional rights to this publication, 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 quelq
5、ue forme que ce soit et par aucun procd, lectronique 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
6、cette publication, utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre 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 leadin
7、g global organization 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 corrigend
8、a or an amendment might have been published. Catalogue of IEC publications: www.iec.ch/searchpub The 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 It also gives information on projects, withdrawn and replaced publications.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 Ju
9、st Published: www.iec.ch/online_news/justpub Stay up to date on all new IEC publications. Just Published 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 term
10、s containing more than 20 000 terms and definitions in English and French, with equivalent terms in 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
11、 or need further assistance, please visit the Customer Service Centre FAQ or contact us: Email: csciec.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 internati
12、onales pour tout ce qui a trait llectricit, llectronique et aux technologies 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.
13、 Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm Le Catalogue en-ligne de 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 remp
14、laces. Just Published CEI: www.iec.ch/online_news/justpub Restez inform sur les nouvelles publications 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 a
15、u monde de termes lectroniques et lectriques. Il contient plus de 20 000 termes et dfinitions en anglais 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/
16、custserv_entry-f.htm Si vous dsirez nous donner 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 60601-2-34 Edition 3.0 2011-05 INTERNATIONAL STANDARD NORME INTE
17、RNATIONALE Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment Appareils lectromdicaux Partie 2-34: Exigences particulires pour la scurit de base et les performances essentielles des appareils
18、de surveillance de la pression sanguine prleve directement INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.55 PRICE CODE CODE PRIX ISBN 978-2-88912-495-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commis
19、sion Electrotechnique Internationale 2 60601-2-34 IEC:2011 CONTENTS FOREWORD . 4 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 C
20、lassification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 20 201.10 Protection against unwanted and excessive
21、radiation HAZARDS 21 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs 23 201.13 HAZARDOUS SITUATIONS and fault conditions . 29 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29 201.15 C
22、onstruction of ME EQUIPMENT . 29 201.16 ME SYSTEMS 30 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30 202 Electromagnetic compatibility Requirements and tests . 30 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical elec
23、trical systems 36 Annexes . 45 Annex AA (informative) Particular guidance and rationale 46 Annex BB (informative) Alarm diagrams 208/IEC 60601-1-8:2006 59 Bibliography 61 Index of defined terms used in this particular standard 62 Figure 201.101 Dynamic test for limitation of energy from different pa
24、rts Recovery test 15 Figure 201.102 Diaphragm leak test . 16 Figure 201.103 Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the PATIENT CONNECTION(S) . 17 Figure 201.104 Measuring circuit for the PATIENT
25、LEAKAGE CURRENT from the APPLIED PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED. 18 Figure 201.105 Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to earth of INTERNALLY POWERED ME EQUIPMENT caus
26、ed by an external voltage on a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 19 Figure 201.106 Clarification of leakage current tests . 20 Figure 201.107 Over-pressure test . 21 Figure 201.108 Test for accuracy of pressure measurements 25 60601-2-34 IEC:2011 3 Figure 201.109 Test sequence
27、 for sensitivity, repeatability, non-linearity, drift and hysteresis . 26 Figure 201.110 Pressure measurement system for accuracy of systolic and diastolic pressure . 27 Figure 201.111 Frequency response of ME EQUIPMENT and TRANSDUCER . 28 Figure 202.101 Test layout for conducted and radiated emissi
28、on and radiated immunity test 31 Figure 202.102 Test circuit for high-frequency surgery interference measurement, when the isolation of the APPLIED PART is in the monitor 34 Figure 202.103 Test circuit for high-frequency surgery protection, when the isolation of the APPLIED PART is in the TRANSDUCER
29、 35 Figure 202.104 Test set-up for high-frequency surgery protection 36 Figure 208.101 Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL ALARM CONDITIONS . 41 Figure 208.102 Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL ALARM CONDITIONS . 42 Figure AA.1 Pressure TRANSDU
30、CER error band . 53 Figure BB.101 NON-LATCHING ALARM SIGNALS without ALARM RESET . 59 Figure BB.102 NON-LATCHING ALARM SIGNALS with ALARM RESET 59 Figure BB.103 LATCHING ALARM SIGNALS with ALARM RESET . 60 Figure BB.104 Two ALARM CONDITIONS with ALARM RESET 60 Table 201.101 ESSENTIAL PERFORMANCE req
31、uirements . 10 Table 208.101 ALARM CONDITION priorities 37 Table 208.102 Characteristics of the BURST of auditory ALARM SIGNALS . 38 4 60601-2-34 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-34: Particular requirements for the basic safety and essential pe
32、rformance of invasive blood pressure monitoring 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-op
33、eration on all questions concerning 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
34、as “IEC Publication(s)”). 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 p
35、reparation. IEC collaborates 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 c
36、onsensus of opinion on the 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 effor
37、ts are made to ensure that 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 Publicatio
38、ns transparently to the maximum 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 itself does not provide any attestation of conformity. Indep
39、endent certification bodies provide 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 l
40、iability shall attach to IEC or its 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 (i
41、ncluding legal fees) and expenses 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
42、 of this publication. 9) Attention 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 60601-2-34 has been prepared by IEC subcom
43、mittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition of IEC 60601-2-34 published in 2001 and constitutes a technical revision. This edition was revised to align structurally with the
44、2005 edition of IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/906/FDIS 62D/923/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
45、-34 IEC:2011 5 This 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, examp
46、les and references: 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 d
47、ivisions within the 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
48、“Clause” followed by 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
49、 to usage described 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 mandatory for compliance with this standard; “may” is used to des
