1、AmericanNationalStandardANSI/AAMI EC13:2002AAMIAssociation for theAdvancement of MedicalInstrumentationCardiac monitors,heart rate meters, and alarmsThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential uses of an AAMIproduct standar
2、d or recommended practice are clearly understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application of current technologiest
3、o patient care, and (2) the encouragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that arbitrary and restricti
4、ve uses are avoided.A voluntary standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measurementtechniques that ca
5、n be used to determine whether the device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance characteristics, instructions f
6、or use, warningsand precautions, and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to facilitateuniformity in rep
7、orting; reaching consensus on these tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for establishing the criteria mu
8、st bedocumented in the rationale.A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a device is usedsafely and ef
9、fectively and that its performance will be maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recommended practice is usually o
10、riented towards healthcare professionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial personnel onsuch subjects a
11、s sterilization processing, methods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether an AAMI standard or recommen
12、dedpractice is relevant to the specific needs of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities). The application of a sta
13、ndard or recom-mended practice is solely within the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose work has been reviewed nati
14、onally(and sometimes internationally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the sense that it responds gen
15、erally to perceived risks andconditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecisionmaking.Despite periodic review and revision (at least once every f
16、iveyears), a standard or recommended practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This review will reveal whether th
17、e document remainsrelevant to the specific needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with existing equipment typically
18、form the basis for thesafety and performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as unsafe. A voluntary standard can be used asone resource, but
19、 the ultimate decision as to product safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individual institution or firm. Aga
20、in, the rationaleaccompanying each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informationand policy guidance and
21、 in the context of professional experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpretation must be approved by le
22、tterballot of the originating committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation in the Standards Monitor sectio
23、n of the AAMI News. TheAssociation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and which is notpublished, by appropri
24、ate notice, as an official interpretation in theAAMI News.American National StandardANSI/AAMI EC13:2002(Revision of ANSI/AAMI EC13:1992)Cardiac monitors, heart rate meters, and alarmsDeveloped byAssociation for the Advancement of Medical InstrumentationApproved 6 May 2002 byAmerican National Standar
25、ds Institute, Inc.Abstract: This American National Standard establishes minimum safety and performance requirements forcardiac monitors, heart rate meters, and alarms that are used to acquire and/or displayelectrocardiographic signals with the primary purpose of continuous detection of cardiac rhyth
26、m.Keywords: diagnostic, ECG, electromedical equipment, heart rate, medical electrical equipment, monitoring,waveformCORRECTED COPY(Incorporates erratum issued 19 December 2002.)AAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of thosesu
27、bstantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respectpreclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, orusing products, processes, or procedures not conforming to the standard. AAMI st
28、andards are subject to periodicreview, 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 thataction be taken to reaffirm, revise, or withdraw this standard no later than five years from the date o
29、f publication.Interested parties may obtain current information on all AAMI standards by calling or writing AAMI.All AAMI standards, recommended practices, technical information reports, and other types of technical documentsdeveloped by AAMI are voluntary, and their application is solely within the
30、 discretion and professional judgment ofthe user of the document. Occasionally, voluntary technical documents are adopted by government regulatoryagencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rulesand regulations.Published byAssociation
31、for the Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2002 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any p
32、art of thisdocument without the prior written permission of the Association for the Advancement of Medical Instrumentation isstrictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part ofthis document (whether internally or externally) witho
33、ut the prior written permission of the Association for theAdvancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, anddamages of $100,000 per offense. For permission regarding the use of all or any part of this document, contactAAMI at 1110 N. Gleb
34、e Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067.Printed in the United States of AmericaISBN 1570201749ContentsPageCommittee representation.vForeword.vi1 Scope .11.1 Inclusions.11.2 Exclusions.11.3 Differences in monitors .22 Normative references.23 Definitions
35、 .24 Requirements.44.1 Labeling requirements .44.1.1 Device markings .44.1.2 Operator manual.64.1.3 Service manual.84.1.4 Pacemaker pulse rejection capability .94.1.5 Summary .104.2 Performance requirements .114.2.1 Operating conditions.114.2.2 Overload protection .124.2.3 Leakage current.124.2.4 Au
36、xiliary output .124.2.5 Respiration, leads-off sensing, and active noise suppression.124.2.6 QRS detection .124.2.7 Range and accuracy of heart rate meter .134.2.8 Alarm system.134.2.9 Special requirements for monitors with ECG waveform display capability .144.2.10 Electromagnetic compatibility.174.
37、2.11 Summary .185 Test methods .225.1 Compliance with the labeling requirements .235.1.1 Device markings .235.1.2 Operator manual.235.1.3 Service manual.275.1.4 Pacemaker pulse rejection capability .275.2 Compliance with the performance requirements .305.2.1 Operating conditions.305.2.2 Overload protection .305.2.3 Leakage current.
