BS ISO 27185-2012 Cardiac rhythm management devices Symbols to be used with cardiac rhythm management device labels and information to be supplied General requirements《心节律管理设备 用于心节.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 27185:2012Cardiac rhythm management devices Symbols to be used with cardiac rhythm management device labels, and information to be supplied General requirementsBS ISO 2718

2、5:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 27185:2012. The UK participation in its preparation was entrusted to T e c h n i c a l Committee CH/150/2, Cardiovascular implants.A list of organizations represented on this committee can be obtained on re

3、quest to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 66029 0 ICS 01.080.20; 11.040.40 Compliance w

4、ith a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2012.Amendments issued since publicationDate T e x t a f f e c t e dBS ISO 27185:2012Reference numberISO 27185:2012(

5、E)ISO 2012INTERNATIONAL STANDARD ISO27185First edition2012-02-15Cardiac rhythm management devices Symbols to be used with cardiac rhythm management device labels, and information to be supplied General requirements Dispositifs de gestion du rythme cardiaque Symboles utiliser avec les marquages de di

6、spositif de rythme cardiaque et informations fournir Exigences gnrales BS ISO 27185:2012ISO 27185:2012(E) COPYRIGHT PROTECTED DOCUMENT ISO 2012 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 mechan

7、ical, including photocopying and microfilm, without permission in 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.

8、org Published in Switzerland ii ISO 2012 All rights reservedBS ISO 27185:2012ISO 27185:2012(E) ISO 2012 All rights reserved iiiContents Page Foreword iv Introduction . v 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 Abbreviated terms . 2 5 General requirements . 3 5.1 Proposal of

9、symbols for adoption . 3 5.2 Requirements for usage . 3 6 Symbols 4 Annex 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 . 2

10、4 Annex D (informative) ISO 27185 response to comment in DIS . 30 Bibliography 31 BS ISO 27185:2012ISO 27185:2012(E) iv ISO 2012 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work o

11、f preparing International Standards is normally carried out through ISO technical committees. Each member 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-governmenta

12、l, in liaison with ISO, also take part in the work. ISO collaborates closely with the International 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

13、 task of technical committees is to prepare International Standards. Draft International Standards adopted 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. Atte

14、ntion is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 27185 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active

15、 implants. BS ISO 27185:2012ISO 27185:2012(E) ISO 2012 All rights reserved vIntroduction This International Standard addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of cardiac rhythm management medic

16、al devices. As such, the items are required to be presented with the device in most regulatory domains. The information can be required on the device itself, as part of the label, or provided with the device. Many countries require the use of their own language to present textual information with me

17、dical devices. This presents problems to device manufacturers and users. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This presents a major problem of translation, design and logistics when multiple languages are included on a single label or piece of docu

18、mentation. Users, presented with devices labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This International Standard proposes solutions to these problems through the use of internationally recognized symbols, with precisely define

19、d meanings, that are independent of language. This International Standard is primarily intended to be used by: manufacturers of cardiac rhythm management medical devices who market identical products in countries having different language requirements for labelling; users of cardiac rhythm managemen

20、t 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 manufacturers; health care providers responsibl

21、e 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 and having responsibility for post-ma

22、rket surveillance. BS ISO 27185:2012BS ISO 27185:2012INTERNATIONAL STANDARD ISO 27185:2012(E) ISO 2012 All rights reserved 1Cardiac rhythm management devices Symbols to be used with cardiac rhythm management device labels, and information to be supplied General requirements 1 Scope This Internationa

23、l Standard specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. Table 1 gives a list of existing symbols that comply with the requirements of this International Standard. This International Standard is applica

24、ble to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling. NOTE Other standards specify additional symbols that are applicable to particular kinds or groups of devices or to part

25、icular situations. Examples of such sources are identified in the Bibliography. This listing is not exhaustive. 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 referenc

26、es, the latest edition of the referenced document (including any amendments) applies. ISO 15223-2, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Symbol development, selection and validation ISO 80416-2, Basic principles for graphical symbols

27、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 character

28、istic information mental representation of a property or properties of an object or set of objects 3.2 compound symbol series of individual symbols linked together to form a piece of information that it is intended to read as a single unit BS ISO 27185:2012ISO 27185:2012(E) 2 ISO 2012 All rights res

29、erved3.3 description normative text that defines the purpose, the application, and the use of the symbol IEC 80416-1:2008, 3.2 3.4 graphical symbol graphical object that communicates characteristic information (3.1) without relying on language to communicate the information 3.5 graphical symbol elem

30、ent graphical object that has a particular meaning and that is used in combination with other graphical symbol elements to create a graphical symbol (3.4) which communicates more complete meaning 3.6 iconic presentation pictorial or graphical representation using familiar objects including alphanume

31、ric characters 3.7 non-programmable device parameter that cannot be modified by the physician 3.8 programmable device parameter that can be modified by the physician 3.9 symbol original drawing of a symbol, prepared in accordance with IEC 80416-1, used for reference or reproduction purposes IEC 8041

32、6-1:2008, 3.3 3.10 symbol used in medical device labelling object presented on the label and/or associated documentation of a medical device that communicates characteristic information (3.1) without relying on knowledge of the language of a particular nation or people by the supplier or receiver of

33、 the information NOTE The symbol can utilize symbolic or iconic presentation. 3.11 title unique name by which a symbol is identified and spoken of IEC 80416-1:2008, 3.5 4 Abbreviated terms ATP Anti-tachycardia pacing A-V Atrial-ventricular CRT-D Cardiac resynchronization therapy defibrillation CRT-P

34、 Cardiac resynchronization therapy pacing ICD Implantable cardioverter defibrillator BS ISO 27185:2012ISO 27185:2012(E) ISO 2012 All rights reserved 3IPG Implantable pulse generator LV Left ventricular PVARP Post-ventricular atrial refractory period RA Right atrial RV Right ventricular NOTE The defi

35、nitions for these terms are provided in the respective standards for the product. See the Bibliography for a list of these standards. 5 General requirements 5.1 Proposal of symbols for adoption Proposals for symbols for adoption into ISO 27185 shall be submitted to the secretariat of ISO/TC 150/SC 6

36、. Symbols being proposed shall be presented following the dimensional criteria and design principles set out in IEC 80416-1 and ISO 80416-2. Where the presentation is symbolic, alphanumeric characters shall not be part of the symbol. Alphanumeric characters may be used when appropriate and relevant

37、in a symbol with iconic presentation. Symbols presented for advice on acceptability or procedural details may be presented as symbol concepts. Symbols presented for formal adoption shall be symbol originals (see 3.9). Any symbol proposed for adoption into this International Standard shall be applica

38、ble to cardiac rhythm management devices and have global applicability. 5.2 Requirements for usage When risk management shows that it is appropriate to use symbols to convey information essential for proper use on the cardiac rhythm management medical devices, on its package, or in associated docume

39、ntation, the symbols provided in Table 1 should be used. NOTE 1 Other symbols can be used to convey different information. Many other standards specify symbols for particular purposes and/or for particular kinds of devices. The Bibliography lists some of these standards. In use, the graphical repres

40、entation of symbols shall comply with that shown in this International Standard, especially with respect to relative dimensions including line thickness, orientation and the absence or presence of filled or shaded areas. As part of risk management and taking account of the specifics and size of the

41、product and its packaging, the manufacturer shall determine the appropriate size necessary for the symbol to be legible for its intended function. Symbols are designed as specified in the requirements of IEC 80416-1 and ISO 80416-2 in order to maximize the clarity of the symbol in a reduced form. NO

42、TE 2 Colours and minimum dimensions are not specified in this International Standard. The manufacturer shall ensure that no additional risk is incurred before using symbols. Alternatively, appropriate strategies shall be adopted to negate the risk. NOTE 3 Additional information regarding risk is ava

43、ilable in ISO 14971. Symbols may be used without accompanying text. When this is not permitted by statute or regulation, the minimum text in all required languages associated with the symbol should be the referent of this International BS ISO 27185:2012ISO 27185:2012(E) 4 ISO 2012 All rights reserve

44、dStandard. Refer to the “Title” column in Table 1 for the minimum text to accompany the symbol. The information under “Informative notes” provides synonyms for titles. When one or more values are associated with a particular symbol, they should be placed immediately adjacent to the primary graphical

45、 element in the symbol most closely related to the value. Examples of associating values with particular symbols are provided in Annex A. 6 Symbols When appropriate, certain information essential for proper use, as required in the appropriate standard, shall be indicated on the medical device, on it

46、s package, or in the associated documentation by using the corresponding symbols given in Table 1. Examples are provided in Annex A. Table 1 Symbols to convey information essential for proper use No. Graphical symbol Title Description of symbol Informative notes Related subclause in AIMD product sta

47、ndards ISO 7000 registration number 6.1 Pacemaker, single chamber, right ventricular To indicate implantable pacemakers that are intended to stimulate and sense in the right ventricle of the heart NOTE A synonym for “Pacemaker, single chamber, right ventricular” is “Pacemaker (single chamber, RV)”.

48、9.3 (ISO 14708-1:2000, EN 45502-1:1998) Description of the device ISO 7000-30386.2 Pacemaker, single chamber, right atrial To indicate an implantable pacemaker that is intended to stimulate and sense in the right atrium of the heart NOTE A synonym for “Pacemaker, single chamber, right atrial” is “Pa

49、cemaker (single chamber, RA)”. 9.3 (ISO 14708-1:2000, EN 45502-1:1998) Description of the device ISO 7000-30396.3 Pacemaker, dual chamber, right atrial, right ventricular To indicate an implantable pacemaker that is intended to stimulate and sense in both the right atrium and right ventricle of the heart NOTE Synonyms for “Pacemaker, dual chamber, right atrial, right ventricular” are “Pacemaker (dual chamber, RA, RV)” or “Pacemaker (dual chamber)”. 9.3 (ISO 14708-1:2000, EN 45502-1:1998) Descripti