BS ISO 15223-2-2010 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied - Symbol development selection and validation《医疗器械 用于医疗.pdf

1、BS ISO 15223-2:2010ICS 01.080.20; 11.040.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical devices Symbols to be used with medical device labels, labelling, and information to be suppliedPart 2: Symbol development, selection and validationThis British St

2、andardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN 978 0 580 57532 7Amendments/corrigenda issued since publicationDate CommentsBS ISO 15223-2:2010National forewordThis British Standard is the UK implementation of ISO 15223-2:2010.The UK pa

3、rticipation in its preparation was entrusted to TechnicalCommittee CH/210/3, General terminology and symbols for MedicalDevices.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof

4、 a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS ISO 15223-2:2010Reference numberISO 15223-2:2010(E)ISO 2010INTERNATIONAL STANDARD ISO15223-2First edition2010-01-15Medical devices Symbols to be used with

5、 medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation Dispositifs mdicaux Symboles utiliser avec les tiquettes, ltiquetage et les informations fournir relatifs aux dispositifs mdicaux Partie 2: Dveloppement, slection et validation de s

6、ymboles BS ISO 15223-2:2010ISO 15223-2:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer per

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9、 Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in

10、 writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS IS

11、O 15223-2:2010ISO 15223-2:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Principles for identification and development of new symbols .3 4.1 Identifying the need for a symbol 3 4.2 Symbols with horizontal

12、 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 evaluation 4 5.3 Second evaluation.4 6 Classification of risk .7 7 Concept development.7 7.1 Existence of other sy

13、mbols7 7.2 Symbol design .8 8 Evaluation.8 8.1 Testing early symbol concepts8 8.2 Comprehension testing 9 8.3 Memory testing 9 8.4 Usability testing.9 9 Acceptance criteria .10 9.1 General .10 9.2 Symbols with no to low safety relevance .10 9.3 Symbols with moderate to high safety relevance10 Annex

14、A (normative) Information to be provided during the symbol development process for adoption of a symbol into ISO 15223-1 .11 Annex B (normative) ISO/TC 145/SC 3 proposal for graphical symbols.12 Annex C (normative) IEC/SC 3C proposal for graphical symbol form 14 Bibliography16 BS ISO 15223-2:2010ISO

15、 15223-2:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each m

16、ember body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

17、Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards a

18、dopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of p

19、atent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15223-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This first edition of ISO 15223-2, together with ISO 15223-1:2007, canc

20、els and replaces ISO 15223:2000, which has been technically revised. ISO 15223 consists of the following parts, under the general title Medical devices Symbols to be used with medical device labels, labelling and information to be supplied: Part 1: General requirements Part 2: Symbol development, se

21、lection and validation BS ISO 15223-2:2010ISO 15223-2:2010(E) ISO 2010 All rights reserved vIntroduction The ISO 15223 series of International Standards addresses symbols that can be used to convey information that is essential for the safe and proper use of medical devices. As such, in most regulat

22、ory domains the symbols are required to be presented with the device. The information can be required to be presented on the device itself, as part of the label or provided with the device. Many countries require that their own language be used to present textual information with medical devices. Th

23、is presents problems to device manufacturers and users. Faced with the requirement to produce labelling in a number of different languages, manufacturers might have to increase the size of the package or label, thus potentially increasing packaging waste, or compressing the information, thus comprom

24、ising legibility. Users presented with devices labelled in a number of different languages can experience confusion and delay in locating the needed information in an appropriate language. ISO 15223-1 proposes solutions to these problems through the use of internationally recognized symbols, with pr

25、ecisely defined meanings, that are independent of language. While compiling the symbols presented in ISO 15223-1, it was recognised that a systematic methodology for the development and presentation of symbols was needed. ISO/TC 210 began by formulating a “best practices” document, Guide to the deve

26、lopment and registration of symbols for use in the labelling of medical devices. When this guide was circulated to interested parties, a number of regulatory authorities were of the opinion that they would have greater confidence in the use of symbols to replace text if the best practices set out in

27、 the Guide were expressed as normative requirements in a standards document. Some of the best practices for symbols development and usage have been translated into normative requirements in ISO 15223. Much of the information required on a medical device itself, as part of the label, or provided with

28、 the device constitutes information for safety within an integrated approach to risk management. As with any risk control measure, the manufacturer needs to verify the effectiveness of the information for safety before it can be accepted. The use of standardized symbols agreed by consensus on an int

29、ernational basis can address the confusion that users can experience when presented with labelling in a number of different languages. However, the proliferation of symbols without control and harmonization is undesirable and detracts from the effectiveness of using symbols to convey information for

30、 safety. In addition, some users and regulatory authorities have concerns that the unrestricted use of symbols without validation can represent a hazard. This part of ISO 15223 includes methods for validating those candidate symbols being proposed for inclusion in ISO 15223-1. It can also be used by

31、 manufacturers and regulators for validating symbols for use with medical devices, where suitable symbols are not standardized. This document has been prepared by ISO/TC 210 to influence the quality of symbols developed for use in labelling by establishing a process that addresses the need to ensure

32、 quality of symbols accepted in ISO 15223-1 by: establishing need; providing guidance on development of symbols; carrying out testing to make sure that the candidate symbol is suitable for adoption and use. When the processes detailed in this part of ISO 15223 have been carried out, the probability

33、of misinterpretation of symbols accepted in ISO 15223-1 is reduced. BS ISO 15223-2:2010BS ISO 15223-2:2010INTERNATIONAL STANDARD ISO 15223-2:2010(E) ISO 2010 All rights reserved 1Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol d

34、evelopment, selection and validation 1 Scope This part of ISO 15223 specifies 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. I

35、f the symbol validation process detailed in this part of ISO 15223 has been 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

36、part of ISO 15223 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited a

37、pplies. For undated references, the latest edition of the referenced document (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, labelling a

38、nd information to be supplied Part 1: General requirements 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 Te

39、rms 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 BS ISO 15223-2:2010ISO 15223-2:2010(E) 2 ISO

40、2010 All rights reserved3.2 associative strength test procedure for comparing the strength of an association between a candidate symbol and several possible meanings 3.3 characteristic information information that represents the property or properties of a symbol 3.4 comprehension test procedure for

41、 quantifying the degree of understanding by the target group of the candidate symbol NOTE Adapted from ISO 9186-1:2007, definition 3.1. 3.5 description normative text that defines the purpose, the application and the use of the symbol NOTE Adapted from IEC 80416-1:2008, definition 3.2. 3.6 symbol co

42、ncept diagrammatic representation of a candidate symbol which conveys the essential elements of the symbol but which has not yet been produced as a symbol original on a pattern template 3.7 symbol original drawing of a graphical symbol, including the corner markings, prepared in accordance with IEC

43、80416-1 and, where appropriate, ISO 80416-2 NOTE Adapted from IEC 80416-1:2008, definition 3.8. 3.8 symbol used in medical device labelling graphic representation appearing on the label and/or associated documentation of a medical device which communicates characteristic information without the supp

44、lier or receiver of the information relying on knowledge of the language of a particular nation or people NOTE The symbol can be an abstract pictorial or graphic representation, or one that uses familiar objects including alphanumeric characters. 3.9 title unique name by which a graphical symbol is

45、identified and spoken of NOTE Adapted from IEC 80416-1:2008, definition 3.9. 3.10 target group user population characterized by such factors as age, gender, education, occupation, cultural background, experience and training, and physical ability when relevant BS ISO 15223-2:2010ISO 15223-2:2010(E)

46、ISO 2010 All rights reserved 33.11 usability characteristic of the symbol which establishes effectiveness, efficiency, ease of user learning and user satisfaction NOTE Adapted from IEC 62366 10. 4 Principles for identification and development of new symbols 4.1 Identifying the need for a symbol When

47、 identifying the need for a symbol, the following elements shall be considered: a) the benefits derived from using a symbol; b) the intended target group: their training and knowledge of, and experience with, the medical device(s) where the candidate symbol is intended to be used; their general medi

48、cal knowledge. 4.2 Symbols with horizontal applications The development of symbols with horizontal applications to a wide range of medical devices in a number of geographic or regulatory areas should be encouraged when there is a clear and significant need for a symbol. This is particularly true whe

49、n these symbols are used to meet regulatory requirements. Such symbols shall be considered prime candidates for inclusion in ISO 15223-1. 4.3 Symbols for use within a restricted range of device types The development of symbols for use within a restricted range of device types or within specific geographic or regulatory areas should be encouraged only if the need is clear and significant. The process of identifying the need should take account of the target group and the arrangements foreseen for public