1、ANSI/AAMIEC53:2013ECG trunk cables and patient leadwiresAmerican National StandardObjectives and uses of AAMI standards and recommended 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
2、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 and effective application of current technologies to patient care, and (2) the encouragement of new technologies.
3、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 these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical dev
4、ice 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 for clinical use, and the measurement techniques that can be used to determine whether the device conforms with
5、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 device, including performance characteristics, instructions for use, warnings and precautions, and other data conside
6、red important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can repre
7、sent 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 must be provided and the reasons for establishing the criteria must be documented in the rationale. A recommende
8、d 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 and practices that will help ensure that a device is used safely and effectively and that its performance will b
9、e 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 device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professiona
10、ls, 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 performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, method
11、s 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 understanding industrial practices. In determining whether an AAMI standard or recommended practice is relevant to th
12、e 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 are adopted by government regulatory or procurement authorities). The application of a standard or recommended prac
13、tice 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 health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes
14、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 safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceiv
15、ed 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 never replace responsible decision-making. Despite periodic review and revision (at least once every five years),
16、 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 initially developed and the specific rationale for each of its provisions. This review will reveal whether the docu
17、ment 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 practice to current procedures and practices. While observed or potential risks with existing equipment typically f
18、orm 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 information will serve to identify a particular product as “unsafe“. A voluntary standard can be used as one resource,
19、 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 practice should be analyzed in the context of the specific needs and resources of the individual institution or f
20、irm. 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 recommended practice is truly useful only when it is used in conjunction with other sources of information and policy
21、 guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official i
22、nterpretation 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 and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpr
23、etation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this pro
24、cedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI EC53:2013 (Revision of ANSI/AAMI EC53:1995 and ANSI/AAMI EC53A:1998) ECG TRUNK CABLES and PATIENT LEADWIRES Developed by Association for the Advancement of M
25、edical Instrumentation Approved 19 November 2013 by American National Standards Institute, Inc. Abstract: The objective of this standard is to allow ECG TRUNK CABLES and PATIENT LEADWIRES to be interchanged between ECG DEVICES with isolated PATIENT connections by establishing a common interface betw
26、een the TRUNK CABLE and the PATIENT LEADWIRE connectors. Performance and safety criteria for TRUNK CABLES and PATIENT LEADWIRES used with isolated PATIENT connectors are also specified. This standards original scope related to TRUNK CABLES and PATIENT LEADWIRES used with cardiac monitors. The scope
27、was extended to include PATIENT LEADWIRES used with other ECG DEVICES including diagnostic electrocardiographs, ambulatory ECG (Holter) recorders/event recorders and ECG telemetry. Keywords: electrocardiographic monitoring; cardiac monitoring; cables; patient leadwires AAMI Standard This Association
28、 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, whether they have approved the standard or not, from manufacturing, marketing
29、, 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 standard may be revised or withdrawn at any time. AAMI procedures require that act
30、ion 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 visiting the AAMI website at www.aami.org. All AAMI standards, recommended prac
31、tices, 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. Occasionally, voluntary technical documents are adopted by government regulatory
32、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 Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association fo
33、r 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 electronic retrieval system, without the prior written permission of AAMI. A
34、ll 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 prior written permission of the Association for the Advancement of Medical I
35、nstrumentation. 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 form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlingt
36、on, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570205108 Contents Page Committee representation v Foreword . vi 1 Scope 1 2 Normative references 1 3 Definitions . 1 4 Test methods 2 5 Requirements 3 5.1 *Labeling requirements . 3 5.1.1
37、Package labeling 3 5.1.2 CABLE YOKE labeling 3 5.1.3 PATIENT LEADWIRE termination labeling 3 5.1.4 *Labeling to identify the location of current-limiting devices . 3 5.1.5 Optional labeling to identify accessories as not being DEFIBRILLATION-PROOF 3 5.2 Construction requirements 3 5.2.1 *PATIENT LEA
38、DWIRE to TRUNK CABLE interconnection 3 5.2.2 *Current-limiting devices . 5 5.3 Performance requirements TRUNK CABLES and PATIENT LEADWIRES . 5 5.3.1 *Non-DEFIBRILLATION-PROOF TRUNK CABLES and PATIENT LEADWIRES 5 5.3.2 *Cable and leadwire noise 5 5.3.3 *Flex life of TRUNK CABLE and PATIENT LEADWIRE F
39、LEX RELIEF 6 5.3.4 *Tensile strength of cable connections . 7 5.3.5 *Number of connector mating/unmating cycles 8 5.3.6 *Connector retention force 8 5.3.7 *Contact resistance 8 5.3.8 *Leadwire resistance 8 5.3.9 *Dielectric withstand voltage 9 Annex A . 11 Rationale for the development and provision
40、s of this standard 11 A.1 Introduction . 11 A.2 Rationale for specific provisions of this standard 11 Tables Table 1Flex life of TRUNK CABLE and PATIENT LEADWIRE FLEX RELIEF . 6 Table 2Tensile strength of cable connections in N . 7 Table 3Number of connector mating/unmating cycles . 8 Table 4Leadwir
41、e resistance ( ) . 9 Figures Figure 1 - Non-shielded PATIENT LEADWIRE to CABLE YOKE connection 4 Figure 2 - Shielded PATIENT LEADWIRE to CABLE YOKE connection (equipment side) 4 Figure 3 - Shielded PATIENT LEADWIRE to CABLE YOKE connection (PATIENT side) . 4 Figure 4 Test setup for cable noise measu
42、rement 6 Figure 5 Flex life test setup . 7 Figure 6 Wire-to-wire (each pair) dielectric withstand test 10 Figure 7 Wire-to-shield dielectric withstand test . 10 Figure 8 Internal-to-external-conductor dielectric withstand test circuit 10 iv 2014 Association for the Advancement of Medical Instrumenta
43、tion ANSI/AAMI EC53:2013 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AA
44、MI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI EC53:2013 v Committee representation Association f
45、or the Advancement of Medical Instrumentation Electrocardiograph (ECG) Committee This standard was developed by the ECG/Electrocardiograph Committee of the Association for the Advancement of Medical Instrumentation. Committee approval of the standard does not necessarily imply that all committee mem
46、bers voted for its approval. At the time this document was published, the AAMI Electrocardiograph Committee had the following members: Cochairs: Richard A. Sunderland Ahmet Turkmen Brian J. Young Members: Robert William Bain, CBET, Baltimore Medical Engineers An oscilloscope with a differential ampl
47、ifier having a 3 decibel ( dB) bandwidth between 0.1 and 100 hertz (Hz) (6 dB per octave roll off) capable of resolving a 10 microvolt (V) signal. The input impedance of the differential channel shall be at least 1 megohm (M). The 3 dB mid-band amplitude accuracy shall be 5%; A cable flexing apparat
48、us capable of securely clamping the cable to the flexing head and rotating through an arc of 90o; A pull test apparatus capable of applying an axial force along a cable or connector of at least 135 newton (N); A volt/ohm meter with the following minimum specifications: d.c. voltage range 10 V (2%);
49、a.c. voltage range (rms) 10 V (2%); d.c. resistance 0.1 to 1 M (2%). 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI EC53:2013 3 Test circuits Unless otherwise specified, use resistors with a maximum 5% tolerance for frequencies up to 1 megahertz (MHz), non-polarized capacitors of suitable rating, with a maximum tolerance of 10% and inductors with a maximum tolerance of 5%. Test signals Unless otherwise specified, input test signals shall be accurate to 1% (d.c. voltages) or 2 % (a.c. voltages). 5 R
