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1、Association for the Advancement of Medical Instrumentation ANSI/AAMI EC38:2007 Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems Objectives and uses of AAMI standards and recommended practices I
2、t 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 advancement ar
3、e (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, provided that
4、 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 criteria that shoul
5、d 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 the informati
6、on 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 performance characte
7、ristics 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 minimum safety
8、 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 address device p
9、erformance 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 purchaser or user of t
10、he 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 recommended pra
11、ctices, 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 guidelines may be use
12、ful 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 recommended practices a
13、re 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 practice reflects the
14、 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 clinical needs a
15、nd, 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 reference in res
16、ponsible 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 must carefully re
17、view 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 devices and equ
18、ipment, 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 criteria to exist
19、ing 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, cost-benefit c
20、onsiderations. 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 underlying its p
21、rovision. 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 Requests for inte
22、rpretations 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 Standards Board. Th
23、e 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 responsibilit
24、y 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 ANSI/AAMI EC38
25、:2007 (Revision of ANSI/AAMI EC38:1998) Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems Developed by Association for the Advancement of Medical Instrumentation Approved 10 December 2007 by Ame
26、rican National Standards Institute, Inc. Abstract: To establish particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems that provide continuous recording and analysis of ECG. Keywords: ambulatory electrocardiographic system, ambulatory reco
27、rder, electrocardiogram, electrode, continuous recorder 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 respect preclude
28、 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 NOTICE: This A
29、AMI 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 five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI.
30、 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. Occasionally, voluntary technical documents
31、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 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.
32、aami.org 2008 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 Adva
33、ncement 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 Inst
34、rumentation. 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 at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-
35、1067. Printed in the United States of America ISBN 1-57020-312-1 Contents Page Glossary of equivalent standards. vii Committee representation . ix Background of ANSI/AAMI adoption of IEC 60601-2-47:2001 x AAMI Deviations to IEC 60601-2-47:2001 xi SECTION ONE GENERAL 1 Scope and object .1 1.1 Scope .
36、1 1.2 Object.1 1.3 Particular Standards1 1.5 Collateral Standards2 *2 Terminology and definitions2 5 Classification.3 6 Indentation, marking and documentation .3 6.8.2 Instructions for use4 SECTION TWO ENVIRONMENTAL CONDITIONS *10 Environmental conditions .5 10.2.1 Environment.5 SECTION THREE PROTEC
37、TION AGAINST ELECTRIC SHOCK HAZARDS 20 Dielectric strength5 20.3 Values of test voltages 5 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength.6 SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION *36 ELECTROMAGNETIC COMPATIBILITY7 36.201 Emissions7 36.
38、201.1 Radio frequency (RF) emissions7 36.202 Immunity7 *36.202.1 Electrostatic discharge.7 *36.202.2 Radiated radio-frequency electromagnetic fields7 36.202.6 Magnetic fields8 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESS
39、IVE TEMPERATURES AND OTHER SAFETY HAZARDS 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .4 20.2 Particular requirements for EQUIPMENT with an APPLIED PART.5 Foreword xxvii Introductionxxix 50 Accuracy of operating data.8 *50.101 Automated analysis9 *50.101.1 Standard databases to be use
40、d to evaluate automated analyses9 *50.101.2 Performance reporting requirements9 *50.101.3 Physician report - minimum requirements .9 51 Protection against hazardous output.10 *51.5 Incorrect output.10 *51.5.1 Input dynamic range10 *51.5.2 Input impedance .11 *51.5.3 Common mode rejection11 *51.5.4 G
41、ain accuracy.12 *51.5.5 Gain stability.12 *51.5.6 Amplitude calibration.12 *51.5.7 System noise 13 *51.5.8 Multichannel crosstalk13 *51.5.9 Frequency response13 *51.5.10 Minimum feature size 14 *51.5.11 Function in the presence of pacemaker pulse 15 *51.5.12 Timing accuracy16 *51.5.13 Hard copy grid
42、 standard 16 *51.5.14 Gain settings and switching.17 *51.5.15 Temporal alignment.17 51.5.16 Special considerations for high speed superimposition display (optional).17 51.5.17 Lead Definitions 18 51.5.18 Baseline stability.19 51.5.19 Patient event marks 19 51.5.20 Full disclosure (miniature displays
43、)19 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS *56 Components and general assembly19 *56.7 Batteries .19 *56.7.101 Monitoring time and retention of data .20 Annexes Appendix LReferences Publications mentioned in this Standard25 A
44、nnex AA (informative)Guidance and rationale26 Tables Table 101Lead color codes .4 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT Figure 103Test signal for input dynamic range test according to 51.5.122 Figure 104General test circuit for 51.5.22 Figure 105Test circui
45、t for common mode rejection according to 51.5.3.23 Figure 106Test circuit for pacemaker pulse tolerance according to 51.5.1124 Figures Figure 101Test set-up for conductive emission test according to 36.201.1 .20 Figure 102Test set-up for radiated emission and radiated immunity test according to 36.2
46、01.1 and 36.202.2 .21 2008 Association for the Advancement of Medical Instrumentation ? AAMI EC38:2007 vii 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
47、 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 referenced International Standards may be under consideration for U.S. adoptio
48、n by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 I
49、dentical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:
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