IEC 60601-2-31-2008 Medical electrical equipment - Part 2-31 Particular requirements for basic safety and essential performance of external cardiac pacemakers w.pdf

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1、 IEC 60601-2-31Edition 2.0 2008-03INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils lectromdicaux Partie 2-31: Exigences particu

2、lires pour la scurit de base et les performances essentielles des stimulateurs cardiaques externes source dnergie interne IEC60601-2-31:2008 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication ma

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17、EMedical electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils lectromdicaux Partie 2-31: Exigences particulires pour la scurit de base et les performances essentielles des stimulateu

18、rs cardiaques externes source dnergie interne INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE WICS 11.040.01 PRICE CODECODE PRIXISBN 2-8318-9665-7 2 60601-2-31 IEC:2008 CONTENTS FOREWORD.3 INTRODUCTION.6 201.1 Scope, object and related standards .7 201.2 Normativ

19、e references 8 201.3 Terms and definitions9 201.4 General requirements10 201.5 General requirements for testing ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents11 201.8 Protection against electrical HAZARDS from ME EQUIPM

20、ENT15 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS16 201.10 Protection against unwanted and excessive radiation HAZARDS16 201.11 Protection against excessive temperatures and other HAZARDS16 201.12 Accuracy of controls and instruments and protection against hazardous ou

21、tputs17 201.13 HAZARDOUS SITUATIONS and fault conditions.21 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .21 201.15 Construction of ME EQUIPMENT .21 201.16 ME SYSTEMS 21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21 202 Electromagnetic compatibility Requirements an

22、d tests .21 Annexes .23 Annex AA (informative) Particular guidance and rationale24 Bibliography34 Index of defined terms used in this particular standard35 Figure 201.101 Measuring circuit for the PATIENT AUXILIARY CURRENT for ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE.16 Figure 201.102 M

23、easuring circuit for the MAXIMUM TRACKING RATE 19 Figure 201.103 Initial oscilloscope display when measuring MAXIMUM TRACKING RATE .19 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 11 Table 201.102 DUAL CHAMBER connector terminal marking .12 Table 201.103 Measurement method accuracy 1

24、8 Table 202.101 Static discharge requirements.22 Table AA.1 EXTERNAL PACEMAKER HAZARD inventory .25 60601-2-31 IEC:2008 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pac

25、emakers with internal power source 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 question

26、s 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 as “IEC Publication(s)”

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29、he 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 efforts are made to ensure th

30、at 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 Publications transparently to the

31、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 provides no marking procedure to indicate its approval and cannot be rendered respon

32、sible for any equipment declared to be in conformity with an IEC Publication. 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 and members of its technica

33、l 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 Publication or any other IEC Pub

34、lications. 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 Publication may be the subject o

35、f patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-31 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition ca

36、ncels and replaces the first edition published in 1994 and its Amendment 1 (1998). This edition constitutes a technical revision. This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains minimal technical revisions from the first edition. 4 60601-2-31 IEC:2008 The text of

37、 this particular standard is based on the following documents: Enquiry draft Report on voting 62D/603/CDV 62D/667/RVC 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. This publication has been drafted in ac

38、cordance 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: in smaller type. Normative text of

39、 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 table of contents, inclusive of al

40、l 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 the clause number. References to

41、subclauses within this collateral 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 in Annex H of the ISO/IEC Directiv

42、es, 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 stand

43、ard; “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 in Annex AA. A list of all parts o

44、f the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. 60601-2-31 IEC:2008 5 The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “

45、http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 6 60601-2-31 IEC:2008 INTRODUCTION The minimum safety requirements specified in this particular standard are considered to

46、provide for a practical degree of safety in the operation of external cardiac pacemakers with an internal power source. Basically, CARDIAC PACEMAKERS treat cardiac arrhythmias. Such arrhythmias reduce cardiac output and can lead to confusion, dizziness, loss of consciousness and death. The objective

47、 of pacing is to restore cardiac rhythm and output appropriate to the PATIENTs physiological needs. There are two distinct families of CARDIAC PACEMAKERS, IMPLANTABLE PACEMAKERS and EXTERNAL PACEMAKERS. EXTERNAL PACEMAKERS are used to pace PATIENTS temporarily prior to implanting an IMPLANTABLE PACE

48、MAKER as well as for temporary pacing related to other medical procedures, e.g. open heart surgery. CARDIAC PACEMAKERS differ in the various ways in which they maintain and monitor cardiac activity in different circumstances. The simplest model stimulates the atrium or ventricle independently of the

49、 cardiac activity; others detect atrial or ventricular activity and stimulate the atrium or ventricle as and when this is necessary; others, more complex, detect the spontaneous heart activity and stimulate appropriately the atrium and/or the ventricle. Certain PACEMAKERS work on preset frequency values, amplitudes and impulse duration. Others can have several values for parameters. Standards