1、ANSI/AAMI/ISO 27185: 2012Cardiac rhythm management devices Symbols to be used with cardiac rhythm management device labels, and information to be supplied General requirementsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objec
2、tives 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
3、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 they are drafted with attention t
4、o 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
5、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 information that should be provided with th
6、e 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 dev
7、elopment 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
8、 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 device performance per se, but rather proc
9、edures 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
10、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 recommended practices, while not addressing devic
11、e 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 i
12、n 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, t
13、hey 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 committ
14、ee 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 pat
15、ient 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 s
16、hould 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
17、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 and equipment, and in applying a recommen
18、ded 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
19、 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-benefit considerations. Similarly, a recomm
20、ended 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 o
21、r 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
22、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 Board. The interpretation will become offic
23、ial 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 expl
24、anation 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/ISO 27185:2012 Cardiac rhythm manageme
25、nt devices Symbols to be used with cardiac rhythm management device labels, and information to be supplied General requirements Approved 20 November 2011 by Association for the Advancement of Medical Instrumentation Approved 13 January 2012 by American National Standards Institute Abstract: Identifi
26、es requirements for the development and use of symbols that may be used to convey information on the safe and effective use of cardiac rhythm management medical devices. The document is limited to symbols applicable to cardiac rhythm management medical devices that may be marketed globally. These sy
27、mbols may be used on the device itself or its labels. Keywords: CRMD, packaging, labeling AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standar
28、d 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 standards are subject to periodic review, and users are cautioned to obtain the lates
29、t 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 the date of publication. Interested parties may obtain current information on all AAMI standa
30、rds 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 voluntary, and their application is solely within the discretion and professional ju
31、dgment 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 by Association for the Advancement of Med
32、ical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced
33、 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 of this document (whet
34、her 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 all or any part of this
35、document, complete the reprint request form at www.aami.org or contact AAMI at 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 1-57020-436-5 Contents Page Glossary of equivalent standards iv Commit
36、tee representation. vi Background of AAMI adoption of ISO 27185:2012 . vii Foreword . viii Introduction ix 1 Scope. 1 2 Normative references 1 3 Terms and definitions 1 4 Abbreviated terms 3 5 General requirements 3 5.1 Proposal of symbols for adoption 3 5.2 Requirements for usage 3 6 Symbols 4 Anne
37、x A (informative) Examples of use of symbols 16 Annex B (informative) Graphical symbol system for implantable cardiac devices 19 Annex C (informative) Validation report for symbols included in this International Standard . 24 Annex D (informative) ISO 27185 response to comment in DIS . 30 Bibliograp
38、hy 31 iv 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 27185:2012 Glossary 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 ado
39、pted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the U.S. column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI.
40、 For example, ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be con
41、sidered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/(R)2012 and ANSI/AAMI ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) Major technical variations C1 Identical to Corrigend
42、um 1 users of cardiac rhythm management medical devices who draw their supplies from a number of sources and can have varied language capabilities. This International Standard can also be of assistance to distributors of cardiac rhythm management medical devices or other representatives of manufactu
43、rers; health care providers responsible for training as well as those being trained; those responsible for post-market vigilance; health care regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices
44、 and having responsibility for post-market surveillance. x 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 27185:2012 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 27185:2012 1 American National Standard ANSI/AAMI/ISO 27185:2012 Cardiac r
45、hythm management devices Symbols to be used with cardiac rhythm management device labels, and information to be supplied General requirements 1 Scope This International Standard specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm manage
46、ment medical devices. Table 1 gives a list of existing symbols that comply with the requirements of this International Standard. This International Standard is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be use
47、d on the devices themselves or their labeling. NOTE Other standards specify additional symbols that are applicable to particular kinds or groups of devices or to particular situations. Examples of such sources are identified in the Bibliography. This listing is not exhaustive. 2 Normative references
48、 The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 15223-2, Medical devices Symbols to be used
49、with medical device labels, labeling and information to be supplied Symbol development, selection and validation ISO 80416-2, Basic principles for graphical symbols for use on equipment Part 2: Form and use of arrows IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment Part 1: Creation of graphical symbols for registration 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 characteristic information mental representation of a property or properties of an object or se
