ANSI AAMI 60601-2-25-2011 Medical electrical equipment - Part 2-25 Particular requirements for the basic safety and essential performance of electrocardiographs.pdf

1、ANSI/AAMI/IEC 60601-2-25:2011/(R)2016Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographsAmerican National StandardAmerican National Standard ANSI/AAMI/IEC 60601-2-25:2011/(R)2016(Revision of ANSI/AAMI EC11:1991/(R)20

2、07) Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs Approved 30 November 2011 by AAMIApproved 23 May 2012 and reaffirmed 6 January 2017 by American National Standards Institute, Inc. Abstract: Specifies basic saf

3、ety and essential performance requirements for electrocardiographs for the production of ECG reports for diagnostic purposes. This particular standard does not include the part of electrocardiographs that provide vector loops or ambulatory electrocardiographic equipment covered by IEC 60601-2-47 and

4、 cardiac monitors covered by IEC 60601-2-27. Keywords: ECG, electrocardiograph, medical electrical equipment, ECG report AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. T

5、he existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users ar

6、e cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain curr

7、ent information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within

8、the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI

9、4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by the Association for the Advancement of Medical Instrumentation All Rights 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,

10、 including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted 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

11、) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil 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 repri

12、nt 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: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-442-5 CONTENTS Glossary of equivalent standards vi Committee representation . viii Backg

13、round of AAMI adoption of IEC 60601-2-27:2011 . ix FOREWORD . x INTRODUCTION . xii 201.1 Scope, object and related standards 1 201.2 Normative references . 3 201.3 Terms and definitions . 3 201.4 General requirements 5 201.5 General requirements for testing of ME EQUIPMENT . 5 201.6 Classification o

14、f ME EQUIPMENT and ME SYSTEMS . 6 201.7 ME EQUIPMENT identification, marking and documents 7 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 10 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 16 201.10 Protection against unwanted and excessive radiation HAZAR

15、DS 16 201.11 Protection against excessive temperatures and other HAZARDS 17 201.12 Accuracy of controls and instruments and protection against hazardous outputs 17 201.13 HAZARDOUS SITUATIONS and fault conditions 32 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 32 201.15 Construction of ME E

16、QUIPMENT 32 201.16 ME SYSTEMS . 32 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 33 202 Electromagnetic compatibility Requirements and tests 33 Annexes 39 Annex AA (informative) Particular guidance and rationale. 40 Annex BB (informative) ELECTRODES, their positions, identifica

17、tions and color codes 48 Annex CC (informative) LEADS, their identification and color codes (other than those specified in 201.12.4.102) . 50 Annex DD (informative) Polarity of PATIENT LEADS (other than those specified in 201.12.4.102) 51 Annex EE (informative) Additional marking of ELECTRODES . 52

18、Annex FF (informative) Definitions and rules for the measurement of ELECTROCARDIOGRAMS 53 Annex GG (informative) Calibration and test data sets 59 Annex HH (informative) CTS test atlas . 61 Bibliography 92 Index of defined terms used in this particular standard 93 Figure 201.101 ELECTRODE position a

19、ccording to Frank 9 Figure 201.102 Test of protection against the effects of defibrillation (differential mode) (see 201.8.5.5.1) . 14 Figure 201.103 Test of protection against the effects of defibrillation (common mode) (see 201.8.5.5.1) . 15 Figure 201.104 Application of the test voltage between L

20、EAD WIRES to test the energy delivered by the defibrillator 16 Figure 201.105 Test circuit for COMMON MODE REJECTION and NOISE level 23 Figure 201.106 General test circuit . 25 Figure 201.107 Triangular waveforms for test E of Table 201.107 27 Figure 201.108 Input impulse signal and ELECTROCARDIOGRA

21、PH response . 27 Figure 201.109 Circuit for test of linearity . 29 Figure 201.110 Result of linearity test 29 Figure 201.111 Pacemaker overload test circuit . 31 Figure 202.101 Set-up for radiated and conducted emission test 34 Figure 202.102 Set-up for radiated immunity test 35 Figure 202.103 Test

22、circuit for HF surgery protection measurement . 38 Figure 202.104 Test setup for HF surgery protection measurement 39 Figure BB.1a LEADS and colors for fetal ECG (see Table BB.2) 49 Figure BB.1b Positions of the ELECTRODES on the fetus for fetal ECG (see Table BB.2) 49 Figure BB.2 LEAD positions and

23、 colors for fetal scalp ECG (see Table BB.2) 49 Figure FF.1 Normal ELECTROCARDIOGRAM . 53 Figure FF.2 Determination of global intervals (example) . 54 Figure FF.3 Waveform durations, isoelectric segments . 55 Figure FF.4 QRS complex with small R-wave(s) (see Figure FF.5, FF.6) 57 Figure FF.5 Detail

24、of small accepted R-wave 57 Figure FF.6 Detail of small rejected R-wave . 58 Figure HH.1 Nomenclature of calibration ECGS 64 Figure HH.2 Nomenclature of analytical ECGs . 67 Table 201.101 ESSENTIAL PERFORMANCE requirements 5 Table 201.102 ELECTRODES, their position, identification and color code . 8

25、 Table 201.103 Protection against the effect of defibrillation (test conditions) 13 Table 201.104 Acceptable mean differences and standard deviations for global intervals and Q-, R-, S-durations on calibration and analytical ECGS 18 Table 201.105 Acceptable mean differences and standard deviations f

26、or global durations and intervals for biological ECGs . 18 Table 201.106 LEADS and their identification (nomenclature and definition) 20 Table 201.107 Frequency response 26 Table 201.108 PATIENT ELECTRODE connection for pacemaker pulse display test . 32 Table AA.1 ELECTRODE positions and electrical

27、strength requirements 42 Table BB.1 ELECTRODES, their positions, identifications and color codes (other than described in 201.7.4.101, Table 201.106) 48 Table BB.2 Other ELECTRODE-positions, identifications and color codes not covered by this particular standard 48 Table DD.1 ELECTRODE polarities 51

28、 Table EE.1 Recommended identification and color code for a 14-wire PATIENT CABLE 52 Table GG.1 CALIBRATION and analytical ECGS 59 Table GG.2 Data set for testing of measurement and wave recognition accuracy of biological data 100 selected ECGS of the CSE-study with their numbering in the CSE databa

29、se, to be used in 201.12.1.101.3.2 60 Table HH.1 Naming of signals (calibration ECGS) 65 Table HH.2 Naming of signals (analytical ECGs) 66 vi 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-25:2011 Glossary of equivalent standards International Standards adopted

30、 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 International Standard. NOTE: Documents are sort

31、ed 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 without change in 2009. Other normativel

32、y 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 ES60601-1:2005/(R)2012 and ANSI/AAMI ES

33、60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (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-governmental organizatio

34、ns liaising with the IEC also participate in this preparation. 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

35、 express, as nearly as possible, an international consensus 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 C

36、ommittees in 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, IEC Na

37、tional Committees undertake to apply IEC Publications 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 do

38、es not provide any attestation of conformity. Independent 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 h

39、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 of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature what

40、soever, 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 Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced public

41、ations 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 of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International stan

42、dard IEC 60601-2-25 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, p

43、ublished in 2003. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/944/FDIS 62D/957/RVD 2012 Association for the Advancement of Medical Instrumentation A

44、NSI/AAMI/IEC 60601-2-25:2011 xi 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 accordance with the ISO/IEC Directives, Part 2. In this standard, the following print ty

45、pes 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 tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD,

46、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 all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a

47、 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 subclauses within this particular standard are by number only. In this standard, the c

48、onjunctive “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 Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that

49、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 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