1、ANSI/AAMI/IEC 60601-2-21:2009/A1:2016Medical electrical equipment Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmersAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objecti
2、ves 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 are (1) a continued increase in the sa
3、fe 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 they are drafted with attention to
4、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 should be considered in qualifying the de
5、vice 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 information that should be provided with the
6、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 characteristics often necessitates the devel
7、opment 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 safety and performance criteria, referee t
8、ests 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 device performance per se, but rather proced
9、ures 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 of the device as a frame of reference fo
10、r 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 recommended practices, while not addressing device
11、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 be useful to health care professionals in
12、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 practices are voluntary (unless, of course, the
13、y 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 reflects the collective expertise of a committee
14、 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 needs and, ultimately, to help ensure patie
15、nt 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 in responsible decision-making, but it sho
16、uld 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 carefully review the reasons why the document wa
17、s 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 and equipment, and in applying a recommende
18、d 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 existing equipment. No single source of i
19、nformation 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-benefit considerations. Similarly, a recommen
20、ded 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 its provision. In summary, a standard or
21、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 interpretations of AAMI standards and re
22、commended 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 Board. The interpretation will become officia
23、l 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 responsibility for any characterization or explan
24、ation 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 60601-2-21:2009/A1:2016 (Amendment 1
25、 to ANSI/AAMI/IEC 60601-2-21:2009) Medical electrical equipment Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers Approved 5 June 2016 by Association for the Advancement of Medical Instrumentation Approved 10 November 2016 by American Nationa
26、l Standards Institute, Inc. Abstract: Addresses changes to several clauses in IEC 60601-2-212009, which has been adopted as ANSI/AAMI/IEC 60601-2-21:2009. Keywords: electromedical equipment, infant radiant warmer AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) st
27、andard implies a consensus of 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
28、 not conforming to the standard. 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 standa
29、rd no later than five years from the date 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
30、technical documents developed by 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 which case the ad
31、opting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2016 by the Association for the Advancement of Medical Instrumentation All Rights
32、Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication 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 submit
33、ted to AAMI. 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 internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including c
34、ivil and criminal penalties, and damages of $100,000 per offense. For permission 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 Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-5
35、25-1067. Printed in the United States of America ISBN 1-57020-630-9 Contents Page Glossary of equivalent standards iv Committee representation v Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-21:2009 . vi Foreword vii List of amendments 1 iv 2016 Association for the Advancement of Me
36、dical Instrumentation ANSI/AAMI/IEC 60601-2-21:2009/A1:2016 Glossary of equivalent standards International Standards or Technical Reports adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that
37、has been adopted by AAMI (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 2016 Association for the Advancement of Medical Instrumentation ANSI
38、/AAMI/IEC 60601-2-21:2009/A1:2016 v Committee representation Association for the Advancement of Medical Instrumentation Infant Incubator Committee The adoption of Amendment 1 to IEC 60601-2-21 as an amendment to an existing national standard, ANSI/AAM/IEC 60601-2-21:2009 was initiated by the AAMI In
39、fant Incubator Committee. U.S. representatives played 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 Infant Incubator Committee had the f
40、ollowing members: Cochairs Bryan Overton, Draeger Medical Systems, Inc. Robert White, Memorial Health System Members Joseph Dyro Gary Harding, Greener Pastures Robert Hijazi, St. Louis VA Medical Center John Learish, Christiana Care Health Services Crystal Lewis, FDA/CDRH Divya Murali, Stryker Instu
41、ments Andrew Richards, G.E. Healthcare Dave Westlin, 3M Healthcare Alternates Keith Marin, FDA/CDRH Ulf Timme, Draeger Medical Systems NOTEParticipation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agenc
42、ies. vi 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-21:2009/A1:2016 Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-21:2009 As indicated in the foreword to the main body of this document (page vii), the International Electrotechnical Commissio
43、n (IEC) is a worldwide organization for standardization comprising of all national electrotechnical committees. The United States is one of the IEC members that took an active role in the development of this amendment, which was developed by the IEC Technical Subcommittee 62D, Electromedical equipme
44、nt. U.S. participation in IEC/SC 62D is organized through the U.S. Technical Advisory Group (TAG) for IEC/SC 62D, administered by AAMI on behalf of the U.S. National Committee of the American National Standards Institute. The U.S. made a considerable contribution to this International Amendment and
45、Standard. AAMI encourages its committees to harmonize their work with International Standards to the extent possible. Upon review of the final draft Amendment 1 to International Standard of IEC 60601-2-21, the AAMI II, Infant Incubator Committee, which serves as the U.S. sub-TAG to 62D decided to ad
46、opt it verbatim. AAMI and ANSI procedures require that standards be reviewed every five years and, if necessary, revised to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other IEC and ISO standards. See the Glossary of Equivalent Standards for
47、a list of IEC and ISO standards adopted by AAMI, which gives the corresponding U.S. designation and the level of equivalency with the IEC and ISO standard. The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and up
48、dated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as advances are made in technology and as new data come to light. This standard reflects the conscientious efforts of concerned health care professionals and medical device manufacturers
49、to develop a standard for those performance levels that can be reasonably achieved at this time. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. NOTEThis background does not contain provisions of the Amendment 1 to American National Standard, Medical electrical equipment Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers, (ANSI/AAMI/IEC 60601-2-21), but it does provide
