ANSI EC12-2000 Disposable ECG electrodes (FDA RECOGNIZED).pdf

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1、ANSI/AAMI EC12:2000/(R)2015Disposable ECG electrodesAmerican National StandardThe Objectives and Uses of AAMI Standardsand Recommended PracticesIt is most important that the objectives and potential uses of an AAMIproduct standard or recommended practice are clearly understood.The objectives of AAMI

2、s technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application of current technologiesto patient care, and (2) the encouragement of new technologies. It isAAM

3、Is view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that arbitrary and restrictive uses are avoided.A voluntary standard for a medical device recommend

4、s to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measurementtechniques that can be used to determine whether the device conformswith the safety and p

5、erformance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance characteristics, instructions for use, warningsand precautions, and other data considered important in

6、 ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to facilitateuniformity in reporting; reaching consensus on these tests canrepresent a considerable p

7、art of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for establishing the criteria must bedocumented in the rationale.A recommended practice provides guidel

8、ines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a device is usedsafely and effectively and that its performance will be maintained.Although a device

9、 standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a frame of reference for device evaluation. Similarly, eventhough a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manu

10、facturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial personnel onsuch subjects as sterilization processing, methods of collecting data toestablish saf

11、ety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether an AAMI standard or recommendedpractice is relevant to the specific needs of a potential user of t

12、hedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities). The application of a standard or recom-mended practice is solely within the discretion and pro

13、fessionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose work has been reviewed nationally(and sometimes internationally). As such, the consensusrecommend

14、ations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the sense that it responds generally to perceived risks andconditions that may not always be relevan

15、t to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecision-making.Despite periodic review and revision (at least once every fiveyears), a standard or recommended practice is necessarily a static

16、document applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This review will reveal whether the document remainsrelevant to the specific needs of the user.Particul

17、ar care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with existing equipment typically form the basis for thesafety and performance criteria defined in a st

18、andard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as “unsafe.” A voluntary standard can be used asone resource, but the ultimate decision as to product safety andefficacy must take i

19、nto account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individual institution or firm. Again, the rationaleaccompanying each AAMI standard and recommended pr

20、actice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informationand policy guidance and in the context of professional experience andjudgment.INTERPRETATI

21、ONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Vice President, Standards.An official interpretation must be approved by letter ballot of theoriginating committee and subsequently reviewed and appro

22、ved bythe AAMI Standards Board. The interpretation will become officialand representation of the Association only upon exhaustion of anyappeals and upon publication of notice of interpretation in the“Standards Monitor” section of the AAMI News. The Association forthe Advancement of Medical Instrumen

23、tation disclaims responsibilityfor any characterization or explanation of a standard or recommendedpractice that has not been developed and communicated inaccordance with this procedure and that is not published, byappropriate notice, as an official interpretation in the AAMI News.American National

24、Standard ANSI/AAMI EC12:2000/(R)2015 (Revision of ANSI/AAMI EC12:1991)Disposable ECG electrodesDeveloped byAssociation for the Advancement of Medical InstrumentationApproved 13 May 2000 and reaffirmed 24 August 2010 and 30 December 2015 by American National Standards Institute, Inc.Abstract: This st

25、andard contains minimum labeling, safety, and performance requirements; test methods;and terminology for disposable electrocardiographic (ECG) electrodes.Keywords: disposable electrodes, ECG monitoring, pregelled, nonpolarizing, electrode systemAAMI StandardThis Association for the Advancement of Me

26、dical Instrumentation (AAMI) standard implies a consensus of thosesubstantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respectpreclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, orusing produc

27、ts, processes, or procedures not conforming to the standard. AAMI standards are subject to periodicreview, 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 thataction be taken to reaffirm, revise

28、, 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.Published byAssociation for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301Arlington, VA 22

29、203-1633www.aami.org 2000 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association fo

30、r the 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 Me

31、dical 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 at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fa

32、x: (703) 525-1067.Printed in the United States of AmericaISBN 1570201390ContentsPageCommittee representation.ivForewordv1 Scope11.1 Inclusions.11.2 Exclusions12 Normative references .13 Definitions and abbreviations14 Requirements .24.1 Labeling requirements .24.2 Performance requirements 24.2.1 Pac

33、kaging and shelf life.24.2.2 Electrical performance.34.3 Safety requirements.44.3.1 Biological response .44.3.2 Pre-attached leadwire safety .44.4 Adhesive performance (duration of use)45 Tests .45.1 Labeling .45.2 Performance 45.2.1 Packaging and shelf life.45.2.2 Tests for electrical performance 4

34、5.3 Safety.65.3.1 Biological response evaluation 65.3.2 Pre-attached leadwire safety .65.4 Adhesive performance (duration of use)7AnnexesA Rationale for the development and provisions of this standard 8B Cited references .14Tables1 Summary of labeling requirements .22 Summary of performance requirem

35、ents .3Figures1 Test circuit for offset instability/internal noise determination 52 Defibrillation overload test circuit (all capacitor and resistor values have a toleranceof 10%) 5iv 2000 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI EC12:2000Committee representationAssocia

36、tion for the Advancement of Medical InstrumentationElectrocardiograph (ECG) CommitteeThis standard was developed by the ECG/Electrodes Working Group of the Electrocardiograph Committee of theAssociation for the Advancement of Medical Instrumentation. Committee approval of the standard does notnecess

37、arily imply that all committee members voted for its approval.At the time this document was balloted, the AAMI Electrocardiograph Committee had the following members:Cochairs: James J. Bailey, MDDavid Mortara, PhDMembers: James J. Bailey, MD, National Institutes of HealthAlan S. Berson, PhD, Nationa

38、l Heart, Lung, and Blood InstituteDavid L. Daly, U.S. Food and Drug AdministrationArthur R. Eddy, Jr., ConMed Corp.Stacy Gehman, Quinton Instrument Co.Paul Lander, Flow Metrix, Inc.George Moody, Massachusetts Institute of TechnologyDavid Mortara, PhD, Mortara Instrument, Inc.Shankara Reddy, PhD, Mar

39、quette Medical Systems, Inc.William Saltzstein, Medtronic-Physio ControlJonathan Steinberg, MD, St. Lukes Roosevelt HospitalRoy D. Wallen, Optical Sensors, Inc.Alternate: Robert J. Cangelosi, U.S. Food and Drug AdministrationAt the time this document was balloted, the ECG/Electrodes Working Group ha

40、d the following members:Cochairs: David L. DalyArthur R. Eddy, Jr.Members: Alan S. Berson, PhD, National Heart, Lung, Blood InstituteHatim M. Carim, PhD, 3M HealthcareDavid L. Daly, U.S. Food and Drug AdministrationGail Darcey, Agilent TechnologiesArthur R. Eddy, Jr., ConMed CorporationMelvin N. Fin

41、k, CBET, Service MasterPradeep M. Gupte, MSBME, Westchester County Medical CenterCarl V. Hays, Batavia, ILM. Richard Jacobs, Hines VA HospitalMartin J. Kutik, PPD ConsultingKay Rutishauser, RN, American Association of Critical Care NursesLouis P. Scheps, CAS Medical Systems Inc.Wayne Shockloss, Kend

42、all HealthcareAlan J. Stankus, PE, John F. Kennedy Memorial HospitalMark Zimmerman, GE-Marquette Medical Systems, Inc.Alternates: John Hughes, GE-Marquette Medical Systems, Inc.Kevin Katzenmaier, 3M HealthcareCarla Mond, Agilent TechnologiesMichael Simon, ConMed CorporationNOTEParticipation by feder

43、al agency representatives in the development of this standard does not constituteendorsement by the federal government or any of its agencies. 2000 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI EC12:2000 vForewordThis revised standard (third edition) was developed by the ECG

44、 Electrodes Working Group of the AAMI ECGCommittee. The objective of this standard is to provide minimum labeling, safety, and performance requirements thatwill help ensure safety and efficacy in the clinical use of disposable electrocardiographic (ECG) electrodes.One of the most significant changes

45、 in this edition is the inclusion of the adhesive performance section, which wasnot included in earlier editions because of the lack of data. In the second edition of this standard, one of the mostsignificant changes made in revising this standard (which was first approved in August 1984) was the ex

46、pansion ofthe scope to cover all disposable electrodes in keeping with new products on the market. In addition, biocompatibilityand pre-attached leadwire safety requirements have been added to the performance requirements.Many of the electrical performance requirements and methodologies set forth in

47、 this standard are based on studiesperformed at the UBTL Division of the University of Utah Research Institute, under contract with the Food and DrugAdministration (FDA), Bureau of Medical Devices. The contributions of UBTL and FDA personnel to this standardsdevelopment effort are gratefully acknowl

48、edged.The concepts incorporated in this standard should not be considered inflexible or static. This standard, like anyother, must be reviewed and updated periodically to assimilate progressive technological developments. To remainrelevant, it must be modified as advances are made in technology and

49、as new data are collected.This standard reflects the conscientious efforts of those substantially concerned with its scope and provisions todevelop a standard for those performance levels that could be reasonably achieved at the present time.As used within the context of this standard, “shall” indicates requirements strictly to be followed in order to conformto the standard; “should” indicates that among several possibilities, one is recommended as particularly suitable,without mentioning or excluding others, or that a certain course of action is preferred but not necessarily