American National ANSI/AAMI EC11:1991 Standard Diagnostic electrocardiographic devices AAMI Association for the Advancement of Medical Instrumentation AAMI Association for the Advancement of Medical Instrumentation 1110 N. Glebe Rd., Suite 220 Arlington, VA 22201-4795 @ 2000 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Copyright and Permissions Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of these documents without the prior written permission of the Association for the Advancement of Medical Instrumentation or the copyright holder (if not AAMl) is prohibited by law. It is illegal under federal law (17 U.S.C. prior written permission of the copyright holder. Violators risk legal action, including civil and criminal penalties, and damages of $10o,oo0 per offense. For permission regarding the use of all or any part of these documents, 525-1067. Violators of this copyright policy should be reported to AAMl's legal counsel: McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, DC 20006 Attn: Jacqueline A. Henson, Esq. Phone: (202) 496-7500 EC11 Diagnostic electrocardiographic devices Diagnostic electrocardiographic devices ANSI/AAMI EC11-1991 (Revision of ANSI/AAMI EC11-1982 and ANSI/AAMI EC11a-1984) American National Standard Diagnostic electrocardiographic devices Developed by Association for the Advancement of Medical Instrumentation Approved 24 October 1991 by American National Standards Institute Abstract: This standard establishes minimum safety and performance requirements for electrocardiographic (ECG) systems with direct writing devices which are intended for use in ECG contour analysis for diagnostic purposes. Committee representation Association for the Advancement of Medical Instrumentation This standard was developed by the Diagnostic Electrocardiograph Subcommittee under the auspices of the Electrocardiograph Committee. Committee approval of the standard does not necessarily imply that all committee and subcommittee members voted for its approval. The AAMI Electrocardiograph Committee has the following members: Cochairpersons: Stanley A. Briller, M.D. David Mortara, Ph.D. Members: James Bailey, M.D., National Institutes of Health Alan S. Berson, Ph.D., National Heart, Lung and Blood Institute Stanley A. Briller, M.D., Allegheny General Hospital, Pittsburgh, PA Francis Charbonnier, Ph.D., Hewlett-Packard Company David L. Daly, Center for Devices and Radiological Health, FDA Arthur R. Eddy, Jr., Medtronic, Inc David Mortara, Ph.D., Mortara Instruments *Jim Rooks, Medical Data Electronics Alternates: Robert Cangelosi, Center for Devices and Radiological Health, FDA Peter Galen, Hewlett-Packard Company Roy D. Wallen, Hewlett-Packard Company The committee's Diagnostic Electrocardiograph Subcommittee has the following members: Cochairpersons: Alan S. Berson, Ph.D 2000 Association for the Advancement of Medical Instrumentation Peter Galen William O. Adams, Physio-Control Corp. Members: Manolito Adan, SpaceLabs Medical, Inc. Alan S. Berson, Ph.D., National Heart, Lung and Blood Institute Stanley A. Briller, M.D., Allegheny General Hospital, Pittsburgh, PA Stephen Daleo, PPG Biomedical Systems David L. Daly, Center for Devices and Radiological Health, FDA James Dobbins, University of Kansas Medical Center, Kansas City, KS Melvin N. Fink, Servicemaster Peter Galen, Hewlett-Packard Company David Geselowitz, Ph.D., Pennsylvania State University Pradeep M. Gupte, Westchester County Medical Center, Valhalla, NY David Hernke, Marquette Electronics Inc. Haim Klement, Datascope Corp. Jeffrey P. Milsap, CCE, PE, Ohmeda Anesthesia Systems Kay Rutishauser, RN, American Association of Critical Care Nurses William J. Smirles, R2 Medical Systems John G. Webster, Ph.D., University of Wisconsin Alternates: David Brown, Jr., SpaceLabs Medical, Inc. Robert Cangelosi, Center for Devices and Radiological Health, FDA Francis Charbonni