ANSI AAMI 60601-2-27-2011 Medical electrical equipment - Part 2-27 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipme.pdf

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1、ANSI/AAMI/IEC 60601-2-27:2011/(R)2016Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentAmerican National StandardAmerican National Standard ANSI/AAMI/IEC 60601-2-27:2011/(R)2016 (Revision of ANSI

2、/AAMI EC13:2002/(R)2007) Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment Approved 8 December 2010 by AAMIApproved 24 June 2011 and reaffirmed 6 January 2017 by American National Standards Inst

3、itute, Inc. Abstract: This standard specifies basic safety requirements and essential performance forelectrocardiographic (ECG) monitoring equipment. It is applicable to ECG monitoring equipment used in a hospital environment. If it is used outside the hospital environment, such as in ambulances and

4、 air transport, the ECG monitoring equipment shall comply with this standard. This standard is not applicable to electrocardiographic monitors for home use and ECG telemetry systems. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use/

5、intended purpose. Ambulatory (“Holter“) monitors, fetal heart rate monitors, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. Keywords: electromedical equipment, ECG, monitors, medical electrical equipmentAAMI Standard This Associat

6、ion for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, market

7、ing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that

8、action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended p

9、ractices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulato

10、ry agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2011 by the Association for the Advancement of Medical Instrumentation All Ri

11、ghts Reserved This publication is subject to copyright claims of IEC and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitte

12、d to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civ

13、il and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276

14、-0793. Printed in the United States of America ISBN 978-1-57020-404-3CONTENTS Glossary of equivalent standards v Committee representation vii Background of AAMI adoption of IEC 60601-2-27:2011 . viii FOREWORD ix INTRODUCTION xi 201.1 Scope, object and related standards 1 201.2 Normative references .

15、 3 201.3 Terms and definitions 3 201.4 General requirements 5 201.5 General requirements for testing of ME EQUIPMENT . 6 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6 201.7 ME EQUIPMENT identification, marking and documents 7 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12

16、 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiation HAZARDS 17 201.11 Protection against excessive temperatures and other HAZARDS 18 201.12 Accuracy of controls and instruments and protection against hazardous outp

17、uts 20 201.13 HAZARDOUS SITUATIONS and fault conditions . 37 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 37 201.15 Construction of ME EQUIPMENT 37 201.16 ME SYSTEMS . 38 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 38 202 Electromagnetic compatibility Requirements an

18、d tests 38 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems . 44 Annexes 51 Annex AA (informative) Particular guidance and rationale. 52 Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 65 Bibliograp

19、hy 68 Index of defined terms used in this particular standard 69 Figure 201.101 Alternating QRS complexes and ventricular tachycardia waveforms for testing pattern recognition capability according to 201.7.9.2.9.101 b) 4) and 6). 11 Figure 201.102 Test of protection against the effects of defibrilla

20、tion (differential mode) 15 Figure 201.103 Test of protection against the effects of defibrillation (common mode) 16 Figure 201.104 Application of the test voltage between LEAD WIRES to test the energy delivered by the defibrillator 17 Figure 201.105 General test circuit . 21 Figure 201.106 High fre

21、quency response 26 Figure 201.107 Test circuit for COMMON MODE REJECTION 28 Figure 201.108 Baseline reset 29 Figure 201.109 Pacemaker pulse . 30 Figure 201.110 Test waveforms for T-wave rejection 32 Figure 201.111 Normal paced rhythm . 33 Figure 201.112 Ineffective pacing (heart rate at 30/min, pace

22、maker pulse at 80/min) . 33 Figure 201.113 Simulated QRS complex. 33 Figure 201.114 Pacemaker test circuit 34 Figure 202.101 Test layout for radiated and conducted EMISSION test and radiated immunity test . 39 Figure 202.102 Set-up for radiated IMMUNITY test 41 Figure 202.103 Test circuit for HF sur

23、gery protection measurement . 43 Figure 202.104 Test setup for HF surgery protection measurement 44 Figure AA.1 APPLIED PART with multiple PATIENT CONNECTIONS . 55 Figure BB.101 NON-LATCHING ALARM SIGNALS without ALARM RESET 65 Figure BB.102 NON-LATCHING ALARM SIGNALS with ALARM RESET. 65 Figure BB.

24、103 LATCHING ALARM SIGNALS with ALARM RESET 66 Figure BB.104 Two ALARM CONDITIONS with ALARM RESET 66 Table 201.101 ESSENTIAL PERFORMANCE requirements 5 Table 201.102 ELECTRODES and NEUTRAL ELECTRODE, their position, identification and color 8 Table 201.103 Protection against the effect of defibrill

25、ation (test conditions) 14 Table 208.101 ALARM CONDITION priorities for ME EQUIPMENT that includes in its INTENDED USE monitoring of PATIENTS that are not continuously attended by a clinical OPERATOR . 45 Table 208.102 Characteristics of the BURST of auditory ALARM SIGNALS for ME EQUIPMENT that incl

26、udes in its INTENDED USE monitoring of PATIENTS that are not continuously attended by a clinical OPERATOR 46 Table AA.1 Electrode positions and electrical strength requirements 53 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-27:2011 v Glossary of equivalent s

27、tandards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the Internat

28、ional Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed

29、without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI

30、 ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 any IEC National Committee interested in the subject dealt with may participate in this preparatory work.International, governmental and non-governmen

31、tal organizations liaising with the IEC also participate in this preparation.IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditionsdetermined by agreement between the two organizations.2) The formal decisions or agreements of IEC on techn

32、ical matters express, as nearly as possible, an internationalconsensus of opinion on the relevant subjects since each technical committee has representation from all interested IECNational Committees.3) IEC Publications have the form of recommendations for international use and are accepted by IEC N

33、ational Committeesin that sense. While all reasonable efforts 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,

34、IEC National Committees undertake to apply IEC Publications transparentlyto the maximum extent possible in their national and regional publications. Any divergence between any IEC Publicationand the corresponding national or regional publication shall be clearly indicated in the latter.5) IEC itself

35、 does not provide any attestation of conformity. Independent certification bodies provide conformity assessmentservices and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out byindependent certification bodies.6) All users should ensure that they h

36、ave 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 ofits technical committees and IEC National Committees for any personal injury, property damage or other damage of anynature whatsoe

37、ver, whether direct or indirect, or for costs (including legal fees) and expenses arising out of thepublication, 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 publication

38、s isindispensable 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 of patent rights.IEC shall not be held responsible for identifying any or all such patent rights.International standard IEC

39、60601-2-27 has been prepared by IEC subcommittee 62D: Electromedical equipment of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition of IEC 60601-2-27 published in 2005. This edition constitutes a technical revision to the

40、 new structure of IEC 60601-1:2005 (third edition). The text of this particular standard is based on the following documents: FDIS Report on voting 62D/900/FDIS 62D/913/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in t

41、he above table. x 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-27:2011 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 sp

42、ecifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normativetext 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 referr

43、ing to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive ofall 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

44、subclausesof Clause 7).References to clauses within this standard are preceded by the term “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 i

45、f 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 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 w

46、ith thisstandard; “should” means that compliance with a r equirement or a test is recommended but is notmandatory 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 th

47、e 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 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 c

48、ontents 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 publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. 2011 Associ

49、ation for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-27:2011 xi INTRODUCTION This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment Part 1: General requirements for basic safety and essential performance hereinafter referred to as the general standard. The aim of this third edition is to bring this particular standard u