1、ANSI/AAMI/ISO 15223-1:2016Medical devicesSymbols to be used with medical device labels, labelling and information to be suppliedPart 1: General requirementsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential
2、 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 and effective
3、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 these objectives
4、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 device for clinical
5、 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 device, including
6、 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 development of special
7、ized 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 tests must be prov
8、ided 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 procedures and practice
9、s 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 device evaluati
10、on. 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 performance crite
11、ria, 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 understanding ind
12、ustrial 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 are adopted by
13、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 of health care p
14、rofessionals 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 safety. A stan
15、dard 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 should never replace
16、 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 initially devel
17、oped 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 practice to cur
18、rent 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 information will s
19、erve 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 recommended practice shou
20、ld 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 recommended pract
21、ice 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 recommended practic
22、es 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 and representat
23、ion 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 explanation of a standa
24、rd 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 15223-1:2016 Medical devicesSymbols to be used with m
25、edical device labels, labelling and information to be suppliedPart 1: General requirements Approved 15 December 2016 by AAMI Approved 5 January 2017 by American National Standards Institute Abstract: This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which a
26、re marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. Keywords: medical device, symbols, labeling AAMI Standard This Association for the Advancement of Medical In
27、strumentation (AAMI) 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, p
28、rocesses, or procedures 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,
29、or withdraw this standard 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. All AAMI standards, recommended practices, technical information reports, and other types of technical documents develo
30、ped 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 adopting agency is responsib
31、le for enforcement 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 par
32、t 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 submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of
33、 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 civil and criminal penalties, and damages of $100,000 per offense. For permission regard
34、ing 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: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-648-1 Contents Page G
35、lossary of equivalent standards . iv Committee representation. v Background of ANSI/AAMI/ISO 15223-1 . vi Foreword . vii Introduction . ix 1 Scope 1 2 Normative references . 1 3 Terms and definitions . 1 4 General requirements . 2 5 Symbols . 3 Annex A (informative) Examples 21 Annex B (informative)
36、 Use of general prohibition symbol and negation symbol . 25 Bibliography . 26 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 15223-1:2016 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other I
37、nternational Standards. AAMI maintains a current list of each International Standard that 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/s
38、tandards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 15223-1:2016 v Committee representation Association for the Advancement of Medical Instrumentation Symbols and nomenclature for medical devices Working Group The publication of AAMI/ISO 15223-1 as a ne
39、w American National Standard was initiated by the AAMI Symbols and nomenclature for medical devices Working Group, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Symbols and
40、nomenclature for medical devices Working Group (U.S. Sub-TAG for ISO/TC 210/WG 03), chaired by Chuck Sidebottom from PPO Standards LLC played an active part in developing ISO 15223-1. At the time this document was published, the AAMI Symbols and nomenclature for medical devices Working Group had the
41、 following members: Cochairs: Charles B. Sidebottom, PE, PPO Standards LLC Members: Bradford Spring, Becton Dickinson symbol 5.1.1, modified the requirement related to the placement of the manufacturers name and address on IVD labels; symbol 5.1.2, modified the requirement related to the placement o
42、f name and address of the authorized representative in the European Union on IVD labels; symbol 5.4.3, added the information used to indicate an instruction to consult an electronic instructions for use (eIFU); symbol 5.4.5, added the reference to ISO 7000, symbol 2725, “Contains or presence of”; sy
43、mbol 5.5.5, modified the description of the symbol and the requirement regarding use with IVD; A.15, added the examples of the placement of the eIFU indicator. A list of all parts in the ISO 15223 series can be found on the ISO website. viii 2017 Association for the Advancement of Medical Instrument
44、ation ANSI/AAMI/SO 15223-1:2016 NOTE Future symbols intended to appear in this document are to be validated in accordance with ISO 15223-2. This corrected version of ISO 15223-1:2016 incorporates the following correction: in A.9, the graphical symbol of NOTE 2 has been corrected. 2017 Association fo
45、r the Advancement of Medical Instrumentation ANSI/AAMI/SO 15223-1:2016 ix Introduction This document addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are require
46、d to appear with the medical device in most regulatory domains. The information can be required to appear on the medical device itself, as part of the label, or provided with the medical device. Many countries require that their own language be used to display textual information with medical device
47、s. At the same time, manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This can cause problems in relation to translation, design and logistics when multiple languages are included on a single label or piece of documentation. For example, users of medical devic
48、es labelled in a number of different languages can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined descriptions. While compiling symbols to be included
49、 in this document, ISO/TC 210 recognized the need for systematic methodology for the selection, development and validation of symbols proposed for adoption. This is the subject of ISO 15223-2. This document is primarily intended to be used by manufacturers of medical devices who market identical products in countries where there are different language requirements for medical device labelling. It can also be of assistance to distributors of medical devices or other representatives of manufacturers, healthcare providers responsible for training,
