ANSI AAMI 60601-2-47-2012 Medical electrical equipment - Part 2-47 Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.pdf

1、ANSI/AAMI/IEC 60601-2-47:2012/(R)2016Medical electrical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systemsAmerican National StandardAmerican National Standard ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 (Revision of ANSI/A

2、AMI EC38:2007) Medical electrical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems Approved 20 July 2012 by AAMIApproved 1 August 2012 and reaffirmed 6 January 2017 by American National Standards Institute, Inc. Ab

3、stract: Specifies the basic safety and essential performance of ambulatory electrocardiographic (ECG) systems. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essent

4、ially similar results. The systems may first record and store the ECG and analyze it later on a separate unit or record and analyze the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; and b) systems that provide continuous analysis and only partial or l

5、imited recording not allowing a full re-analysis of the ECG. Keywords: ECG, electrocardiograph, electromedical equipment, holter monitors AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope

6、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, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic rev

7、iew, 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 CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time.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 action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested partie

8、s 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 practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application

9、is solely within 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.

10、Published by AAMI 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 distri

11、buted in any form, 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 intern

12、ally or externally) 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,

13、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: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-449-4CONTENTS Glossary of equivalent standards v Committee representat

14、ion vii Background of AAMI adoption of IEC 60601-2-47:2012 . viii FOREWORD ix INTRODUCTION xi 201.1 Scope, object and related standards 1 201.2 Normative references . 3 201.3 Terms and definitions . 3 201.4 General requirements 6 201.5 General requirements for testing of ME EQUIPMENT . 6 201.6 Class

15、ification 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 9 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 9 201.10 Protection against unwanted and excessive radiat

16、ion HAZARDS 9 201.11 Protection against excessive temperatures and other HAZARDS 9 201.12 Accuracy of controls and instruments and protection against hazardous outputs 9 201.13 HAZARDOUS SITUATIONS and fault conditions 35 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 35 201.15 Construction o

17、f ME EQUIPMENT 35 201.16 ME SYSTEMS . 37 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 37 202 Electromagnetic compatibility Requirements and tests 37 Annexes 39 Annex AA (informative) Particular guidance and rationale. 40 Bibliography 63 Index of defined terms used in this part

18、icular standard 64 Figure 201.101 General test circuit for 201.12.4.4 26 Figure 201.102 Test signal for input dynamic range test according to 201.12.4.4.101 . 28 Figure 201.103 Test circuit for common mode rejection according to 201.12.4.4.103 30 Figure 201.104 Test circuit for pacemaker pulse toler

19、ance according to 201.12.4.4.109 . 34 Figure 202.101 Test set-up for conductive emission test according to 202.6.1.1.2 and radiated emission and radiated immunity test according to 202.6.1.1.2 and 202.6.2.3.2 38 Table 201.101 Distributed additional ESSENTIAL PERFORMANCE requirements . 6 Table 201.10

20、2 LEAD WIRE color codes . 8 Table 201.103 Requirements for all arrhythmia algorithms 13 Table 201.104 Requirements for algorithms with optional capabilities . 14 Table 201.105 Beat label classifications . 18 Table 201.106 Example of noise floor calculation results 20 Table 201.107 Example of HRV tes

21、t results . 21 Table 201.108 Run sensitivity summary matrix . 22 Table 201.109 Run positive predictivity summary matrix . 22 Table AA.1 Records to be included in a complete test 41 Table AA.2 Example of a line-format, beat-by-beat performance report 46 Table AA.3 Condensed beat-by-beat summary matri

22、x containing 11 elements 47 Table AA.4 Summary table (matrix format) of beat-by-beat comparison 47 Table AA.5 Example of a line-format SHUTDOWN report . 48 Table AA.6 Example of a line-format report 49 Table AA.7 Example of VF performance report 50 Table AA.8 Example of false VF performance report .

23、 50 Table AA.9 Example of a line-format couplet and run performance report . 51 Table AA.10 Example of device measurements of synthetic test patterns . 52 Table AA.11 Example of predicted ideal values for synthetic test patterns 52 Table AA.12 Example of choice of test patterns 52 Table AA.13 Exampl

24、e of RMS interval differences 56 Table AA.14 Example of summary of frequency components 57 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-47:2012 v Glossary of equivalent standards International Standards adopted in the United States may include normative refer

25、ences 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 sorted by international designation. The code in the

26、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 normatively referenced International Standards may be under

27、 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 ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:

28、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 organizations liaising with the IEC also participate in this

29、 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 express, as nearly as possible, an international

30、 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 Committees in that sense. While all reasonable eff

31、orts 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 Publicat

32、ions 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. Ind

33、ependent 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

34、 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 whatsoever, whether direct or indirect, or for costs

35、(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 publications is indispensable for the correct applicati

36、on 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 60601-2-47 has been prepared by subcommi

37、ttee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition published in 2001. It constitutes a technical revision. This edition was revised to align structurally with the 2005 edition of IEC

38、60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/963/FDIS 62D/980/RVD x 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-47:2012 Full information on the voting for the approval of this particular standar

39、d 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 types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative mate

40、rial 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, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, t

41、he 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 numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to

42、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 if any combination of the conditions i

43、s 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 with this standard; “should” means tha

44、t 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

45、 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 contents of this publication will re

46、main 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. 2012 Association for the Advancement of Medica

47、l Instrumentation ANSI/AAMI/IEC 60601-2-47:2012 xi INTRODUCTION This particular standard concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS. It amends and supplements IEC 60601-1 (third edition 2005): Medical electrical equipment Part 1: General requiremen

48、ts for basic safety and essential performance, hereinafter referred to as the general standard. The requirements of this particular standard take priority over those of the general standard. A “General guidance and rationale” for the requirements of this particular standard is included in Annex AA.

49、It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this standard. xii 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-47:2012 2012 Association for the Advancement of Medi