ANSI NS4-2013 Transcutaneous electrical nerve stimulators.pdf

1、ANSI/AAMI NS4:2013Transcutaneous electrical nerve stimulatorsAmerican 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 objective

2、s of 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 technolog

3、ies. 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 medica

4、l device 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

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7、represent 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 recom

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21、olicy 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 offic

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24、s procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI NS4:2013 (Revision of AAMI NS4:1986(R)2009) Transcutaneous electrical nerve stimulators Developed by Association for the Advancement of Medical Instrume

25、ntation Approved 20 March 2013 by American National Standards Institute Inc. Abstract: This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical stimulators (including TENS) intended for use in the treatment of pain syndrome. Also covere

26、d are labeling requirements for patient leads and electrodes. Keywords: electromedical equipment, labeling, electrical safety, transcutaneous electrical stimulators, leads, electrodes AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of

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30、 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 agencies or procurement authorities. In such cases, the adopting agency is responsible fo

31、r enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproductio

32、n, 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 Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) t

33、o 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 Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For p

34、ermission 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 Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570204950 Contents

35、 Page Glossary of equivalent standards v Committee representation vi Foreword vii 1 Scope 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclusions 1 2 Normative references . 1 3. Requirements . 1 3.1 Labeling Requirements 1 3.1.1 Device Markings 1 3.1.2 Clinician Information 2 3.1.3 Patient Information 3 3

36、.2 Safety and Performance Requirements for the Stimulus Generator . 3 3.2.1 Electrical Safety . 3 3.2.2 Output Characteristics . 3 3.2.3 Functional Controls . 4 3.2.4 Open/Short Circuit Performance . 4 3.2.5 Incorrect Battery Installation 4 3.2.6 Environmental Performance 4 4 Test Methods 4 4.1 Comp

37、liance with the Labeling Requirements 4 4.1.1 Device Markings 4 4.1.2 Clinician Information 4 4.1.3 Patient Information 4 4.2 Compliance with the Safety and Performance Requirements for the Stimulus Generator 5 4.2.1 Electrical Safety . 5 4.2.2 Output Characteristics . 5 4.2.3 Functional Controls .

38、5 4.2.4 Open/Short Circuit Performance . 5 4.2.5 Incorrect Battery Installation 5 4.2.6 Environmental Performance 5 5 Glossary 6 5.1 Electrode system conductive medium . 6 5.2 Lead . 6 5.3 Pulse 6 5.4 Serial number 6 5.5 Stimulus generator 6 5.6 TENS . 6 Annexes Annex A: Labeling/User Guidelines for

39、 Transcutaneous Electrical Nerve Stimulators (Contraindications, Warnings, Precautions) . 7 Annex B: Development and Provisions of this Standard 8 Bibliography . 13 Tables Table B.1 Instantaneous Impedance (ohms) 10 Figures Figure 1 Test setup for waveform measurements . 5 2013 Association for the A

40、dvancement of Medical Instrumentation ANSI/AAMI NS4:2013 v 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 AA

41、MI (and ANSI). Available on the AAMI 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 vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI NS4:2013 Comm

42、ittee representation Association for the Advancement of Medical Instrumentation Transcutaneous Electrical Stimulator Working Group This standard was developed by the AAMI Transcutaneous Electrical Stimulator Working Group under the auspices of the AAMI Neurosurgery Standards Committee. Working Group

43、 approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Transcutaneous Electrical Stimulator Working Group had the following members: Cochairs: Robert J. DeLuca, FDA/CDRH Members: Masahiro Ando, Omron H

44、ealthcare Co Ltd Richard North, MD, Sinai Hospital of Baltimore (Independent Expert) Donald Osborne, MD PE (Independent Expert) Ashish Shah, PhD, Greatbatch Inc. Kok-Swang Tan, PhD, Medical Devices Bureau Health Canada Ted Yantsides, Conmed Corp Alternates: Les Halberg, Greatbatch Inc. NOTE-Particip

45、ation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. At this time this document was published, the AAMI Neurosurgery Committee had the following members: Chairs: Richard North, MD, Sinai Hospital

46、 of Baltimore (Independent Expert) Ashish Shah, PhD, Greatbatch Inc. Members: Robert J. DeLuca, FDA/CDRH Marc A. Flitter, MD (Independent Expert) Jeffrey E. Henderson, Medtronic Inc WHQ Campus Alternates: Les Halberg, Greatbatch Inc. Organizational Member Liaison: Greg Anthony Hrdlicka, Medtronic In

47、c. NOTE-Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI NS4:2013 vii Foreword This standard was developed by

48、 the Transcutaneous Electrical Stimulator working group under the auspices of the AAMI Neurosurgery Committee. The objective of this standard is to provide labeling requirements, certain performance requirements, test methods, terminology, and guidelines that will help establish a reasonable level o

49、f safety and effectiveness for transcutaneous electrical nerve stimulators used in the treatment of pain syndromes. This second edition updates references and corrects typographical errors. As used within the context of this document, “shall” indicates requirements strictly to be followed in order to conform to 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 required, or that (in the ne