ANSI AAMI 60601-2-2-2017 Medical electrical equipment-Part 2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high .pdf

1、ANSI/AAMI/IEC 60601-2-2:2017 Medical electrical equipmentPart 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesAmerican National StandardObjectives and uses of AAMI standards and recommended practi

2、ces It 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 advanceme

3、nt are (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

4、 that 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

5、should be considered 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 performance characteristics of different products. Some standards emphasize the info

6、rmation 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 cha

7、racteristics 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 s

8、afety 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 dev

9、ice 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 manufacturer, it may also be of value to the potential purchaser or user

10、 of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommende

11、d 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 may b

12、e 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 practi

13、ces are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflect

14、s 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 clinical ne

15、eds 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 reference i

16、n 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 careful

17、ly 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 devices an

18、d 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 criteria to

19、existing equipment. 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, cost-bene

20、fit 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 underlying

21、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 Requests for

22、 interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Boar

23、d. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsi

24、bility 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

25、/IEC 60601-2-2:2017 (Revision to ANSI/AAMI/IEC 60601-2-2:2009) Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Approved 11 June 2017 by AAMI Approved 30 June 201

26、7 by American National Standards Institute, Inc. Abstract: Applies to medical electrical equipment which generates high frequency currents intended for the performance of surgical tasks and to surgical accessories intended to conduct, supplement or monitor high frequency energy applied to the patien

27、t from high frequency surgical equipment. Keywords: electromedical equipment, high frequency, high frequency surgical equipment, HF surgical accessory, HF patient circuit AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substa

28、ntially 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. AAMI stan

29、dards 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 date

30、of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are

31、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 which case the adopting agency is responsible for enforceme

32、nt of its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this public

33、ation 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 part

34、 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 a

35、ll or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 978-1-57020-664-1 Contents PageGlossary of equiva

36、lent standards . iv Committee representation . v Background of ANSI/AAMI adoption of IEC 60601-2-2:2017 . vi Foreword vii Introduction . ix Scope, object and related standards . 1 201.1Normative references . 2 201.2Terms and definitions . 3 201.3General requirements . 6 201.4General requirements for

37、 testing of ME EQUIPMENT . 7 201.5Classification of ME EQUIPMENT and ME SYSTEMS 7 201.6ME EQUIPMENT identification, marking and documents 8 201.7Protection against electrical HAZARDS from ME EQUIPMENT 12 201.8201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 26 Protection

38、against unwanted and excessive radiation HAZARDS 26 201.10Protection against excessive temperatures and other HAZARDS. 26 201.11Accuracy of controls and instruments and protection against hazardous outputs 27 201.12Hazardous situations and fault conditions for ME EQUIPMENT . 33 201.13Programmable el

39、ectrical medical systems (pems) 34 201.14Construction of ME EQUIPMENT . 34 201.15201.16 ME SYSTEMS . 38 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 38 201.17202 * ELECTROMAGNETIC DISTURBANCES Requirements and tests 38 202.2 Normative references . 38 202.3 Terms and definitions . 38

40、202.5.2.2.4 Requirements applicable to ME EQUIPMENT that includes RF transmitters 38 202.5.2.2.6 Requirements applicable to ME EQUIPMENT and ME SYSTEMS that claim compatibility with hf surgical equipment 38 202.7 Electromagnetic emissions requirements for ME EQUIPMENT and ME SYSTEMS . 39 202.7.1.2 O

41、perating modes . 39 202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS. 39 202.8.1 General. 39 202.101 Index of defined terms 39 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems . 39 Annexes 40 Anne

42、x AA (informative) Particular guidance and rationale 41 Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL EQUIPMENT . 64 Bibliography . 72 Index of defined terms used in this particular standard . 73 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAM

43、I/IEC 60601-2-2:2017 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 AAMI (and ANSI). Available on the AAMI w

44、ebsite 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 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-2:2017 v Committee representation Associat

45、ion for the Advancement of Medical Instrumentation High Frequency Therapeutic Device Committee The adoption of IEC 60601-2-2 as a revision to an existing national standard, ANSI/AAM/IEC 60601-2-2:2009, was initiated by the AAMI High Frequency Therapeutic Device Committee. U.S. representatives played

46、 an active role in developing the IEC standard. Committee 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 High Frequency Therapeutic Device Committee had the following members: Cochair: Richard S

47、isken Members: Long Chen, FDA/CDRH Roberto Del Cid, Conmed Corporation Jeffrey Eggleston, Medtronic Inc. Bruce Hansel, ECRI Samuel Netherly Richard Sisken, Cook Advanced Technologies Kok-Swang Tan, Medical Devices Bureau Health Canada Lance Tinder, Stryker Instruments Jeffrey Wiser, 3M Healthcare Je

48、an Woloszko, Smith any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Orga

49、nization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical