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1、American National Standard ANSI/AAMI PC69:2000 AAMI Association for the Advancement of Medical Instrumentation Active implantable medical devicesElectromagnetic compatibilityEMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators Copyright Association for th
2、e Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,- The Objectives and Uses of AAMI Standards and Recommende
3、d 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 a
4、dvancement 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,
5、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 criter
6、ia that should be con- sidered 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 per- formance characteristics of different products. Some standards em- ph
7、asize 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 p
8、erformance 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 establishmen
9、t of 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 n
10、ot address 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 manufac- turer, it may also be of value to the potential p
11、urchaser or user of the device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also,
12、 some recommended 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
13、guidelines 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 re
14、commended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recom- mended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommende
15、d practice 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 resp
16、ond to clinical 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 imp
17、ortant reference in responsible decision-making, but it should never replace responsible decisionmaking. 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
18、user must 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 ex
19、isting devices 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 t
20、hese criteria to existing equip- ment. 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, o
21、f course, 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 a
22、nd data underlying 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 PRA
23、CTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the Manager for Technical Development. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Bo
24、ard. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpre- tation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims resp
25、onsibility 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. Copyright Association for the Ad
26、vancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI PC69:2000 Active implant
27、able medical devices Electromagnetic compatibilityEMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators Developed by Association for the Advancement of Medical Instrumentation Approved 3 May 2000 by American National Standards Institute, Inc. Abstract:This
28、 standard specifies test methods appropriate to many interference frequencies, whether high or low, near or far afield. The standard may specify performance limits or require disclosure of performance in the presence of electromagnetic emitters where appropriate. It provides manufacturers of electro
29、magnetic emitters with information about the level of immunity to be expected from active implantable cardiovascular devices. Keywords:test methodology, active implantable medical devices, electromagnetic compatibility, electromagnetic emitters, cardiovascular devices Copyright Association for the A
30、dvancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medic
31、al 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, whether or not he or she has approved the standard, from manufacturing, marketing, purchasing, or using pr
32、oducts, 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 standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm,
33、 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 writing AAMI. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington,
34、VA 22201-4795 2000 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the
35、 Advancement of Medical Instrumentation is strictly prohibited by law. 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 prior written permission of the Association for the Advancement of Medical
36、 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, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 5
37、25-1067. Printed in the United States of America ISBN 157020151X Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking perm
38、itted without license from IHS -,-,- Contents Page Glossary of equivalent standards.v Committee representationvii Acknowledgment. viii Foreword.ix Introductionx 1Scope1 2Normative references .1 3Symbols (and abbreviated terms).1 4Test requirements for the frequency band0 Hz 3,000 MHz.6 Annexes ARati
39、onale.7 BTorso simulator.11 CDipole antennas14 DPacemaker/ICD programming settings.16 ESimulated cardiac signal.19 FCalculation of net power into dipole antenna20 Tables 1List of acronyms and abbreviations 1 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under l
40、icense with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,- 2Requirements for the test setup3 A.1 List of common EM emitters .7 C.1 Dipole description.14 D.1 Pacemaker parameters 1
41、6 D.2 Defibrillator parameters 17 D.3 NASPE/BPEG generic (NBG) pacemaker code .18 Figures A.1 Dipole net power measurements (dipole spacing = 2.5 cm).9 B.1 Torso simulator.12 B.2 Test setup.13 C.1 Example of dipole antenna .15 E.1 Simulated cardiac signal.19 F.1 Test setup.22 F.2 Directional coupler
42、 forward port coupling factor .22 F.3 Directional coupler reverse port coupling factor .23 F.4 Antenna cable attenuation23 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale,
43、 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,- 2000 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI PC69:2000v Glossary of equivalent standards International standards adopted in the United States may include normative references
44、 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.) Other normatively r
45、eferenced international standards may be under consideration for U.S. adoption by AAMI, therefore this list should not be considered exhaustive. International designationU.S. designationEquivalency IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 being prepared for publication. Copy
46、right Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,- vi 2000 Association for the Adva
47、ncement of Medical Instrumentation ! ANSI/AAMI PC69:2000 International designationU.S. designationEquivalency ISO 14937:2000ANSI/AAMI/ISO 14937:2000Identical ISO 14969:1999ANSI/AAMI/ISO 14969:1999Identical ISO 14937:2000ANSI/AAMI/ISO 14937:2000Identical ISO 14971:2000ANSI/AAMI/ISO 14971:2000Identica
48、l ISO 15223:2000ANSI/AAMI/ISO 15223:2000Identical ISO 15225:2000ANSI/AAMI/ISO 15225:2000Identical ISO TS 15843:2000ANSI/AAMI/ISO TIR15843:2000Identical ISO TR 15844:1998AAMI/ISO TIR15844:1998Identical ISO TR 16142:1999ANSI/AAMI/ISO TIR16142:2000Identical Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:47:23 MDTNo reproduction or networking permitted without license from IHS -,-,