1、ANSI/AAMI/IEC 60601-2-20:2009/A1:2016Medical electrical equipment Part 2-20: Particular requirements for the basic safety and essential performance of transport incubatorsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objective
2、s 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 safe
3、 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 th
4、ese 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 devi
5、ce 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 de
6、vice, 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 develop
7、ment 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 tes
8、ts 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 procedur
9、es 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 for
10、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 pe
11、rformance 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 un
12、derstanding 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, they
13、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 o
14、f 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 patient
15、 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 shoul
16、d 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 was
17、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 recommended
18、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 inf
19、ormation 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 recommende
20、d 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 re
21、commended 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 reco
22、mmended 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 official
23、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 explanat
24、ion 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 60601-2-20:2009/A1:2016 (Amendment 1 t
25、o ANSI/AAMI/IEC 60601-2-20:2009) Medical electrical equipment Part 2-20: Particular requirements for the basic safety and essential performance of transport incubators Approved 5 June 2016 by Association for the Advancement of Medical Instrumentation Approved 10 November 2016 by American National St
26、andards Institute, Inc. Abstract: Addresses changes to several clauses in IEC 60601-2-20:2009, which has been adopted as ANSI/AAMI/IEC 60601-2-20:2009. Keywords: electromedical equipment, infant transport incubator AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI)
27、standard 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 procedur
28、es 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 stan
29、dard 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 o
30、f 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
31、adopting 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 Right
32、s 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 subm
33、itted 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
34、 civil 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
35、-525-1067. Printed in the United States of America ISBN 1-57020-629-5 Contents Page Glossary of equivalent standards iv Committee representation v Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-20:2009 . vi Foreword vii List of amendments 1 iv 2016 Association for the Advancement of
36、Medical Instrumentation ANSI/AAMI/IEC 60601-2-20:2009/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 tha
37、t 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 AN
38、SI/AAMI/IEC 60601-2-20:2009/A1:2016 v Committee representation Association for the Advancement of Medical Instrumentation Infant Incubator Committee The adoption of Amendment 1 to IEC 60601-2-20 as an amendment to an existing national standard, ANSI/AAM/IEC 60601-2-20:2009 was initiated by the AAMI
39、Infant 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
40、 following 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 Ins
41、tuments 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 age
42、ncies. vi 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 60601-2-20:2009/A1:2016 Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-20:2009 As indicated in the foreword to the main body of this document (page vii), the International Electrotechnical Commiss
43、ion (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 equip
44、ment. 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 an
45、d 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 60601-2-20, the AAMI II, Infant Incubator Committee, which serves as the U.S. sub-TAG to 62D decided to
46、adopt 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 fo
47、r 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
48、updated 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 manufacturer
49、s 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 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators, (ANSI/AAMI/IEC 60601-2-20), but it does
