1、ANSI/AAMI/IEC 60601-2-4:2010/(R)2015Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillatorsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives
2、and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe a
3、nd effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to thes
4、e objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device
5、 for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the devi
6、ce, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the developme
7、nt of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests
8、 must be provided and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures
9、 and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for de
10、vice evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device perf
11、ormance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in unde
12、rstanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they ar
13、e adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of
14、health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient s
15、afety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should
16、never replace responsible decision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was in
17、itially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended pr
18、actice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of infor
19、mation will serve to identify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended
20、practice should be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or reco
21、mmended practice is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recomm
22、ended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official an
23、d representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanatio
24、n of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/IEC 60601-2-4:2010/(R)2015 (Revision of ANSI
25、/AAMI DF80:2003/(R)2010)Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators Approved 14 October 2010 by Association for the Advancement of Medical Instrumentation Approved 18 November 2010 and reaffirmed 30 December 20
26、15 by American National Standards Institute, Inc. Abstract: This standard concerns th e basic safet y and essential performance of medica l electrical equipment intended to defibrillate the heart by an electrical pulse via electrodes applied either to the patients skin (external electrodes) or to th
27、e exposed heart (internal electrodes). This standard does not apply to implantable defibrillators, remote control defibrillators, external transcutaneous pacemakers, or separate cardiac monitors. This standard amends and supplements IEC 60601-1 (third edition, 2005). Keywords: cardiac defibrillators
28、, automated external defibrillators, 60601-2-4AAMI Standard This Association 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, w
29、hether 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 are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standa
30、rd 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 current information on all AAMI standards by calling or writing AAMI, or by vis
31、iting 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 the discretion and professional judgment of the user of the document. Occas
32、ionally, 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 Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Driv
33、e, Suite 301 Arlington, VA 22203-1633 www.aami.org 2010 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an
34、 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) without the
35、 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 reprint request fo
36、rm at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 157020404-7 Contents Page Glossary of equivalent standards . v Committee representation . vii Background of AAMI ad
37、option of IEC 60601-2-4:2010 . viii FOREWORD ix 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 . 7 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 7 201.7
38、 ME EQUIPMENT identification, marking and documents 7 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against MECAHNICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 19 201.10 Protection against unwanted and excessive radiation HAZARDS 19 201.11 Protection against excessi
39、ve temperatures and other HAZARDS 20 201.12 * Accuracy of controls and instruments and protection against hazardousoutputs 21 201.13 HAZARDOUS SITUATIONS and fault conditions . 23 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24 201.15 Construction of ME EQUIPMENT . 24 201.16 ME SYSTEMS 28
40、 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 28 201.101 * Charging time . 28 201.102 Internal electrical power source . 31 201.103 * Endurance 33 201.104 * Synchronizer . 34 201.105 * Recovery of the MONITOR and/or ECG input after defibrillation . 34 201.106 * Disturbance to
41、the MONITOR from charging or internal discharging . 38 201.107 * Requirements for RHYTHM RECOGNITION DETECTOR . 39 201.108 DEFIBRILLATOR ELECTRODES 40 201.109 * External pacing (U.S.) . 42 202 * Electromagnetic compatibility Requirements and tests 47Annexes 50 Annex C (informative) Guide to marking
42、and labelling requirements for ME EQUIPMENT and ME SYSTEMS . 51 Annex AA (informative) Particular guidance and rationale. 53 Annex BB (informative) Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 . 67 Bibliography 72 Index of defined terms used in this part
43、icular standard 73 Figure 201.101 Dynamic test for limitation of energy from different parts of the ME EQUIPMENT 14 Figure 201.102 Allowed current versus applied test voltage 18 Figure 201.103 Examples of cord anchorages that require testing 27 Figure 201.104 Test apparatus for flexible cords and th
44、eir anchorages . 28 Figure 201.105 Arrangement for test of recovery after defibrillation 36 Figure 201.106 Arrangement of monitoring electrodes on sponge . 37 Figure 201.107 Arrangement for recovery test after defibrillation 37 Figure 201.108 Arrangement for test of disturbance from charging and int
45、ernal discharging 39 Figure 201.109 Test circuit for offset instability/internal noise determination . 46 Figure 201.110 Test circuit for DEFIBRILLATOR overload test of pacing output circuitry . 47 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements . 6 Table 201.102 Rhythm recognition dete
46、ctor categories . 39 Table 201.C.101 Marking on the outside of a CARDIAC DEFIBRILLATOR or its parts 51 Table 201.C.102 Marking of controls and instruments of a CARDIAC DEFIBRILLATOR 51 Table 201.C.103 ACCOMPANYING DOCUMENTS, general . 51 Table 201.C.104 ACCOMPANYING DOCUMENTS, instructions for use .
47、 52 Table 201.C.105 ACCOMPANYING DOCUMENTS, technical description. 52 Table BB.1 Mapping between the elements of the second edition of IEC 60601-2-4 and IEC 60601-2-4:2010 67 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-4:2010 v Glossary of equivalent standar
48、ds International Standards adopted in the United States ma y include normative references to oth er 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 Internationa
49、l 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 without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. a doption by AAMI; therefore, this list should not be considered exhaustive. International designati
