1、ANSI/AAMI/ISO 14117: 2012Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devicesAmerican National StandardObjectives and uses of AAMI standards and recommend
2、ed practices It is most important that the objectives 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
3、advancement are (1) a continued increase in the safe and 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,
4、 provided that they are drafted with attention to these 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 crite
5、ria that should be considered in qualifying the device 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
6、 the information that should be provided with the device, 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 perfor
7、mance characteristics often necessitates the development 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
8、minimum safety and performance criteria, referee tests 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 ad
9、dress device performance per se, but rather procedures 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 purchase
10、r or user of the device as a frame of reference for device 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 r
11、ecommended practices, while not addressing device performance 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 guideli
12、nes may be useful to health care professionals in understanding 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 recommend
13、ed practices are voluntary (unless, of course, they are 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 practic
14、e reflects the collective expertise of a committee of 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 cl
15、inical needs and, ultimately, to help ensure patient safety. 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 re
16、ference in responsible decision-making, but it should 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 mus
17、t carefully review the reasons why the document was initially 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 d
18、evices and equipment, and in applying a recommended practice 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 cri
19、teria to existing equipment. No single source of information 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,
20、cost-benefit considerations. Similarly, a recommended 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 un
21、derlying its provision. In summary, a standard or recommended 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 Req
22、uests for interpretations of AAMI standards and recommended 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 Stand
23、ards Board. The interpretation will become official and 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
24、 responsibility for any characterization or explanation 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
25、ANSI/AAMI/ISO 14117:2012 (Revision of ANSI/AAMI PC69:2007) Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices Approved 24 November 2012 by Association fo
26、r the Advancement of Medical Instrumentation Approved 30 November 2012 by American National Standards Institute Abstract: Specifies a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices. The devices addressed by thi
27、s standard include those that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization. This document details test methods appropriate for the interference frequencies at issue. It specifies performance limits or requires disclosure of performance in the presence of
28、EM emitters, where indicated. Keywords: CRMD, EMC, pacemakers, cardiac AAMI 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 r
29、espect 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 are cautioned to obtain the latest editions. CAUTION
30、 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 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or w
31、riting 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 the discretion and professional judgment of the user
32、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 Association for the Advancement of Medical Instrumentatio
33、n 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 ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in
34、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 internally or e
35、xternally) 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
36、the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-470-5 Contents Page Glossary of equivalent standards . v Committee representation
37、. viii Background of ANSI/AAMI adoption of ISO 14117:2012 ix ForHwRrd x Introduction xi 1 Scope. 1 2 Normative references 1 3 Terms and definitions, symbols and abbreviations . 1 4 Test requirements for the frequency band 0 Hz 3,000 MHz 4 4.1 General 4 4.2 Induced lead current 5 4.3 Protection from
38、persisting malfunction attributable to ambient electromagnetic fields . 12 4.4 Temporary response to continuous wave sources 24 4.5 Protection from sensing EMI as cardiac signals 27 4.6 Protection from static magnetic fields of flux density up to 1 mT 39 4.7 Protection from static magnetic fields of
39、 flux density up to 50 mT 41 4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz 41 4.9 Test requirements for the frequency range of 450 MHz 3,000 MHz . 42 5 Testing above frequency of 3,000 MHz 47 6 Protection of devices from EM fields encountered in a therapeutic enviro
40、nment . 47 6.1 Protection of the device from damage caused by high-frequency surgical exposure . 47 6.2 Protection of the device from damage caused by external defibrillators 49 7 Additional accompanying documentation 53 7.1 Disclosure of permanently programmable sensitivity settings 53 7.2 Descript
41、ions of reversion modes . 53 7.3 Known potential hazardous behavior 53 Annex A (informative) Rationale 54 Annex B (informative) Rationale for test frequency ranges 68 Annex C (informative) Code for describing modes of implantable generators . 74 Annex D (normative) Interface circuits 76 Annex E (inf
42、ormative) Selection of capacitor Cx81 Annex F (normative) Calibration of the injection network (Figure D.5) 82 Annex G (normative) Torso simulator . 84 Annex H (normative) Dipole antennas . 87 Annex I (normative) Pacemaker/ICD programming settings . 89 Annex J (normative) Simulated cardiac signal .
43、92 Annex K (normative) Calculation of net power into dipole antenna . 93 Annex L (informative) Loop area calculations 98 Annex M (informative) Correlation between levels of test voltages used in this International Standard and strengths of radiated fields . 104 Bibliography 111 2012 Association for
44、the Advancement of Medical Instrumentation ANSI/AAMI/ISO 14117:2012 v Glossary of equivalent standards 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
45、 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 U.S. column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. For example, ANSI/AAMI/ISO
46、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. adoption by AAMI; therefore, this list should not be considered exhaustive. Internat
47、ional designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005/(R)2012 Major technical variations IEC 60601-1:2005/A1:2012 ANSI/AAMI ES60601-1:2005/A1:2012 A1 identical IEC Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) C1 identical to Corrige
48、ndum 1 access control systems (radio-frequency identification, or RFID); new wireless service in the ultra-high-frequency and very-high-frequency bands; magnetic levitation rail systems; radio-frequency (RF) medical procedures, such as high-frequency surgery and ablation therapy; metal detectors; ma
49、gnetic resonance imaging; and experimental use of transponders for traffic control. b) 450 MHz 3,000 MHz These are the frequencies, , that are typically associated with personal hand-held communication devices (e.g. wireless telephones and two-way radios). Two decades ago, relatively few pacemaker patients used hand-held transmitters or were exposed to EM fields from portable transmitters. Hand-held, frequency-modulated transceivers for business, public safety, and amateur radio communications represented the predominant applications. However
