ANSI AAMI 15223-2-2010 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 2 Symbol development selection and validation.pdf

1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 15223-2:2010Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied Part 2: Symbol development, selection and validationObjectives and uses of AAMI standards and recommended practic

2、es 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 advancemen

3、t 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 s

5、hould 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 infor

6、mation 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 char

7、acteristics 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 sa

8、fety 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 devi

9、ce 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 recommended

11、 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 be

12、 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 practic

13、es 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 reflects

14、 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 nee

15、ds 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 in

16、 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 carefull

17、y 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 and

18、 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 e

19、xisting 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-benef

20、it 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 i

21、ts 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 Board

23、. 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 responsib

24、ility 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、ISO 15223-2:2010 Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied Part 2: Symbol development, selection and validation Approved 8 March 2010 by Association for the Advancement of Medical Instrumentation Approved 20 April 2010 by American Nationa

26、l Standards Institute, Inc. Abstract: Specifies a process for developing, registering, and validating symbols for use in the labeling of medical devices. Keywords: medical device symbols, validation AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies

27、 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 not conformin

28、g 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 standard no later th

29、an 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 technical docu

30、ments 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 adopting agency

31、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 2010 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This

32、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 submitted to AAMI. I

33、t 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 civil and crimi

34、nal 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: (703) 525-4890; Fax: (703) 525-1067. Printed

35、 in the United States of America ISBN 157020387-3 Contents Page Glossary of equivalent standards iv Committee representation .vi Background of ANSI/AAMI adoption of ISO 15223-2:2010 viii Forewordiv Introduction x 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Principles for identific

36、ation and development of new symbols.3 4.1 Identifying the need for a symbol3 4.2 Symbols with horizontal applications.3 4.3 Symbols for use within a restricted range of device types 3 5 Process for selecting and validating symbols for inclusion in ISO 15223-1 3 5.1 General.3 5.2 Initial evaluation4

37、 5.3 Second evaluation 4 6 Classification of risk.8 7 Concept development.8 7.1 Existence of other symbols .8 7.2 Symbol design.9 8 Evaluation 9 8.1 Testing early symbol concepts .9 8.2 Comprehension testing10 8.3 Memory testing10 8.4 Usability testing 10 9 Acceptance criteria.11 9.1 General.11 9.2

38、Symbols with no to low safety relevance.11 9.3 Symbols with moderate to high safety relevance .11 Annex A (normative) Information to be provided during the symbol development process for adoption of a symbol into ISO 15223-1.12 Annex B (normative) ISO/TC 145/SC 3 proposal for graphical symbols 13 An

39、nex C (normative) IEC/SC 3C proposal for graphical symbol form15 Bibliography .17 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 adopted by AAMI (an

40、d 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 US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/I

41、SO 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 considered exhaustive. Inter

42、national designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 providing guidance on development of symbols

43、; carrying out testing to make sure that the ca ndidate symbol is suitable for adoption and use. When the processes detailed in this part of ISO 15223 have been carried out, the probability of misinterpretation of symbols accepted in ISO 15223-1 is reduced. x 2010 Association for the Advancement of

44、Medical Instrumentation ANSI/AAMI/ISO 15223-2:2010 American National Standard ANSI/AAMI/ISO 15223-2:2010 Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied Part 2: Symbol development, selection and validation 1 Scope This part of ISO 15223 specifi

45、es a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of this part of ISO 15223 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in this part of ISO 15223 has been

46、 complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary. This part of ISO 15223 is not restricted to symbols intended to meet regulatory

47、requirements or specified in regulatory guidelines on labeling. 2 Normative references 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 documen

48、t (including any amendments) applies. ISO 9186-1:2007, Graphical symbols Test methods Part 1: Methods for testing comprehensibility ISO 15223-1:2007, Medical devices Symbols to be used with medical device labels, labeling and information to be supplied Part 1: General requirements ISO 80416-2, Basic

49、 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 appropriateness ranking test procedure for ranking candidate symbols according to their considered appropriateness for representing a particular meaning 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IS