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1、Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-2:2006 Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment American National Standard The 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 con- sidered 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 per- formance characteristics of different products. Some standards em- phasize the inf
6、ormation 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 ch
7、aracteristics 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
8、safety 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 de
9、vice performance 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 manufac- turer, it may also be of value to the potential purchaser or u
10、ser of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented 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 recomm
11、ended practices, 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 m
12、ay be useful 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 pr
13、actices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application 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 r
14、eflects the 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 clini
15、cal needs and, 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 refer
16、ence in responsible 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 c
17、arefully review 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 devi
18、ces and equipment, 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 criter
19、ia to existing equip- ment. 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, c
20、ost-benefit considerations. 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 und
21、erlying its provision. 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 Requ
22、ests for interpretations of AAMI standards and recommended practices must be made in writing, to the Manager for Technical Development. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The in
23、terpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpre- tation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility
24、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/IEC 60
25、601-2-2:2006 (Revision of ANSI/AAMI HF18:2001) Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment Approved 11 July 2006 by Association for the Advancement of Medical Instrumentation Approved 2 November 2006 by American National Standar
26、ds Institute Inc. Abstract: Specifies requirements for the safety of high frequency surgical equipment and HF surgical accessories used in medical practice. High frequency surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or
27、 ophthalmology) is exempt from certain of the requirements of this particular standard. Keywords: electromedical equipment, electrical safety, high frequency surgical equipment AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those
28、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 standard. AAM
29、I 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 five years from the
30、 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 solely
31、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. Published
32、by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2007 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims pf IEC, ANSI, and AAMI. No part of this publ
33、ication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any pa
34、rt 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 permission regarding the use of
35、 all or any part of this document, 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 157020XXXX CONTENTS Glossary of equivalent standards.v Committee representation vii Background of AAMI ad
36、option of IEC 60601-2-2:2006viii FOREWORD. ix INTRODUCTION. xi SECTION ONE GENERAL 1 Scope and object 1 2 Terminology and definitions2 3 General requirements.6 4 General requirements for tests .6 5 Classification.6 6 Identification, marking, and documents 7 7 Power input.11 SECTION TWO ENVIRONMENTAL
37、 CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS 14 Requirements related to classification11 17 Separation.12 18 Protective earthing, functional earthing, and potential equalization .12 *19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS12 *20 Dielectric strength .19
38、SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 Electromagnetic compatibility .20 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANESTHETIC MIXTURES 39 Common requirements for CATEGORY AP and CATEGORY
39、 APG EQUIPMENT.21 SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS *42 Excessive temperatures21 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection, and compatibility .21 46 Human errors22 SECTION EIGHT ACCURACY OF OPERA
40、TING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data.24 51 Protection against hazardous output 26 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions 29 SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components a
41、nd general assembly .29 59 Construction and layout34 Appendix L References Publications mentioned in this standard.44 Annex AA (informative) Guidance and rationale for particular clauses and subclauses.45 Annex BB (informative) Electromagnetic disturbances created by HF SURGICAL EQUIPMENT.67 Glossar
42、y of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalenc
43、y to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Eq
44、uivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variatio
45、ns 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
46、 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2
47、006 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:
48、2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002 and Amendment 1:2006 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 AN
49、SI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002 ANSI/AAMI BE78:2002/A1:2006 Minor technical variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2002 ANSI/AAMI/ISO 10993-12:2002 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI
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