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1、American National Standard ANSI/AAMI HF18:2001 AAMI Association for the Advancement of Medical Instrumentation Electrosurgical devices Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not f
2、or Resale, 12/02/2008 02:35:43 MSTNo reproduction or networking permitted without license from IHS -,-,- The Objectives 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 und
3、erstood. The objectives 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 encourag
4、ement of new technologies. 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
5、 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 should be con- sidered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whet
6、her the device conforms with the safety and performance 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, warnings and pr
7、ecautions, and other data considered 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 c
8、onsensus 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 and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be document
9、ed 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 performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectivel
10、y and that its performance will be maintained. Although a device standard is primarily directed to the manufac- turer, it may also be of value to the potential purchaser or user of the device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually orien
11、ted towards health care professionals, 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
12、as sterilization processing, methods 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 rec
13、ommended 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 are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The applicatio
14、n of a standard or recom- mended practice 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 bee
15、n reviewed nationally (and sometimes 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
16、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 responsible decision-making, but it should never replace responsible decisionmaking. Despite periodic review and revisi
17、on (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 review the reasons why the document was initially developed and the specific rationale for each of its provisions. This
18、 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 equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks
19、 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 existing equip- ment. No single source of information will serve to identify a particular product as “unsafe“. A voluntary
20、 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 considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resour
21、ces 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 provision. In summary, a standard or recommended practice is truly useful only when it is used in conjunction with o
22、ther sources of information and policy 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 Manager for Technical Devel
23、opment. An official interpretation 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
24、 of notice of interpre- tation 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 a
25、ccordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Res
26、ale, 12/02/2008 02:35:43 MSTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI HF18:2001 (Revision of ANSI/AAMI HF18:1993) Electrosurgical devices Developed by CORRECTED VERSION Association for the Advancement of Medical Instrumentation Approve
27、d 11 May 2001 by American National Standards Institute, Inc. Abstract: This standard establishes minimum safety and performance requirements for electrosurgical systems. An electrosurgical system consists of a high frequency electrical current generator, cables, electrodes, and safety devices for de
28、livering this high frequency electrical energy to the patient to accomplish electrosurgery. The system includes the circuitry and devices needed to control the duration, mode of operation, and intensity of the application. Included within the scope of this standard are electrosurgical devices and th
29、e electrosurgical portion of multifunction devices. Examples of devices within the scope of this standard are electrosurgical high frequency generators and directly related accessories, including active electrodes and cables, dispersive electrodes and cables, and footswitches or other operator-contr
30、olled mechanisms for activating the generator output. Keywords:electrosurgical devices, electrosurgical systems, electrosurgery, dispersive electrodes, dispersive cables, electrosurgical high frequency generators Copyright Association for the Advancement of Medical Instrumentation Provided by IHS un
31、der license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/02/2008 02:35:43 MSTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of
32、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, purchasing, or using products, processes, or procedures not conforming to the standar
33、d. 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 action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from
34、the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is sole
35、ly 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 which case the adopting agency is responsible for enforcement of its rules and regulations. Publish
36、ed by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2001 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or othe
37、rwise, 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.) to make copies of all or any part of this document (whether intern
38、ally 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 permission regarding the use of all or any part of this document,
39、contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570201609 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employe
40、es/1111111001, User=Japan, IHS Not for Resale, 12/02/2008 02:35:43 MSTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Committee representation. v Foreword .vi 1Scope.1 2Normative references.1 3Terms and definitions.1 4Requirements.4 4.1Labeling.4 4.1.1Device mark
41、ings .4 4.1.2Generator operators manual4 4.1.3Service manual .4 4.1.4Dispersive electrodes4 4.1.4.1General4 4.1.4.2Electrodes intended for use on infants5 4.1.5Reusable accessory cables 5 4.2Performance and safety5 4.2.1Mechanical construction .5 4.2.2Electrical construction.5 4.2.3Dispersive electr
42、odes5 4.2.3.1Maximum safe temperature rise5 4.2.3.2Electrode contact impedance6 4.2.3.3Electrode adherence.7 4.2.3.4Packaging and shelf life 7 4.2.4Switches7 4.2.5Cables and accessories7 4.2.5.1Dielectric withstand, 60 Hz7 4.2.5.2High frequency leakage current 8 4.2.5.3Sterilization of reusable acce
43、ssories.8 4.2.5.4Dielectric withstand of accessories .9 4.2.5.5Cable strain relief 9 4.2.6Connectors10 4.2.7Indicators and alarms10 4.2.8Safety10 4.2.8.1Generators 10 4.2.8.2Contact quality monitor10 4.2.8.3Defibrillator protection .11 4.2.9Low frequency risk current11 4.2.10High frequency leakage c
44、urrent11 4.3Environmental performance11 4.3.1Voltages11 4.3.2Output open circuited, short circuited .12 4.3.3Output control setting accuracy 12 4.3.4Shipping temperatures12 4.3.5Operating conditions.12 4.3.6Mechanical shock .12 4.4Accuracy of performance specifications12 5Tests 12 5.1Accuracy of ins
45、truments and test apparatus.13 5.2General procedures for the tests.13 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 12/02/2008 02:35:43 MSTNo reproduction or networking p
46、ermitted without license from IHS -,-,- Annexes ARationale for the development and provisions of this standard .14 BAn example of a test setup for measuring the high frequency leakage current of cables21 CAn example of a dielectric withstand test for accessory cables .24 DCited references.26 Tables
47、A.1 Summary of measured currents and durations for transurethral resection procedures.16 A.2 Summary of measured currents and durations for general surgical procedures .17 Figures 1Test setup for measuring electrode contact impedance 6 2Test setup for measuring high frequency leakage current of cabl
48、es8 3Test setup for assessing defibrillator protection.11 B.1 Test setup for measuring high frequency leakage current of cables22 B.2 Capstan, saline fixture; Material: Delrin or equivalent22 B.3 Delrin block, saline fixture; Material: Delrin or equivalent.23 B.4 Cable constraint, saline fixture; Ma
49、terial: Delrin or equivalent .23 C.1 H.F. dielectric withstand test setup 24 C.2 Mains frequency dielectric withstand test setup.25 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 1