BS EN ISO 21531-2009 Dentistry - Graphical symbols for dental instruments《牙科 牙科仪器用图形符号》.pdf

1、BS EN ISO21531:2009ICS 01.080.99; 11.060.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Graphicalsymbols for dentalinstruments (ISO21531:2009)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 Ma

2、rch2009 BSI 2009ISBN 978 0 580 53174 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21531:2009National forewordThis British Standard is the UK implementation of EN ISO 21531:2009.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental instr

3、uments and equipment.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 a contract. Users are responsible for its correct application.Compliance with a British Standard cannot co

4、nfer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21531February 2009ICS 11.060.01; 01.080.99English VersionDentistry - Graphical symbols for dental instruments (ISO21531:2009)Art dentaire - Symboles graphiques pour instrumentsdentaires (ISO 21531:2009)Zahnheil

5、kunde - Graphische Symbole frDentalinstrumente (ISO 21531:2008)This European Standard was approved by CEN on 21 January 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard wit

6、hout any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language

7、made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,Franc

8、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORM

9、UNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21531:2009: EBS EN ISO 21531:2009EN ISO 21531:2009 (E) 3 Foreword This document (EN ISO 21531:2009) has been prepared by

10、 Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest b

11、y August 2009, and conflicting national standards shall be withdrawn at the latest by August 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such pa

12、tent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ire

13、land, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21531:2009 has been approved by CEN as a EN ISO 21531:2009 without any modification. BS EN ISO

14、21531:2009ISO 21531:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Requirements 2 4.1 General. 2 4.2 Use of graphical symbols 2 4.3 Size of symbols. 2 4.4 Representation of names of languages and da

15、tes 2 5 Graphical symbols 3 Bibliography . 13 BS EN ISO 21531:2009ISO 21531:2009(E) iv ISO 2009 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 Standar

16、ds 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-governmental, in liaison with ISO, also take

17、 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 task of technical committees is

18、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. Attention is drawn to the possibility

19、 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 21531 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. BS EN ISO 21531:2009ISO 21531:

20、2009(E) ISO 2009 All rights reserved vIntroduction Graphical symbols are used in many areas of daily life. They give necessary and useful information of many kinds in a visual way. They are used as signals (warning or alarm signals), for general information, as a means of control, for the correct ap

21、plication of machines, instruments, etc. and in may other ways of communication. Their content of information is very often superior to verbal explanations because their information is visually acknowledged instantly and is often kept in memory easier and longer than terms or phonetic explanations.

22、Graphical symbols are internationally understandable without sometimes difficult, possibly misleading and costly translations. Each ISO technical committee is responsible for the selection or creation of graphical symbols within its own field of interest. Graphical symbols may form the main subject

23、of an International Standard, or a single symbol or several symbols may appear as part of a standard covering wider aspects of the subject to which the symbol(s) refer(s). The ISO Technical Management Board has assigned overall responsibility for standardization in the field of graphical symbols to

24、ISO/TC 145, Graphical symbols, and to ISO/TC 10/SC 10, Technical product documentation (tpd) symbols. ISO/TC 210, Quality management and corresponding aspects for medical devices, which is responsible for the development of ISO 15233, has prepared an international guide to the development and regist

25、ration of symbols for use in the labelling of medical devices. This guideline recommends that the proliferation of graphical symbols without international harmonization is undesirable and contrary to these objectives. There is a need for simple, internationally accepted graphical symbols labelling t

26、hat provide general and specific information to the user in a manner that overcomes the limitations of languages. It is in the best interests of safety and health of patients, dentists, dental technicians and other persons, to reduce the confusion inherent in the use of multiple language labelling.

27、Both of these objectives can be met by the use of standardized symbols agreed by consensus on an international basis. The task of determining technical requirements to allow the use of specific symbols is best taken up by bodies expert in the relevant areas. ISO/TC 106/SC 4/WG 5, Number coding syste

28、m, has taken up this responsibility by developing this International Standard. This International Standard has been prepared to reduce the need for multiple translations of words into national languages, to simplify labelling whereever possible and to prevent separate development of different symbol

29、s to convey the same information. This International Standard contains a series of symbols (pictograms) for use in dentistry. Their application should be considered in the literature, for the labelling and packaging of devices used in dentistry, on items of dental equipment and instruments. Their us

30、e is unlimited and a most helpful means of communication within dentistry. BS EN ISO 21531:2009BS EN ISO 21531:2009INTERNATIONAL STANDARD ISO 21531:2009(E) ISO 2009 All rights reserved 1Dentistry Graphical symbols for dental instruments 1 Scope This International Standard presents a series of graphi

31、cal symbols for dental instruments. They are set out particularly for this area of dentistry or corresponding specific areas within dentistry. General symbols are taken from relevant ISO, IEC or other international documents. Several new symbols presented by manufacturers or users have been added. B

32、ecause many dental products are considered in some cases as medical devices and in some cases not as medical devices, in dentistry the restricted usage of the symbols specified in ISO 15223 is considered as not practical. It is the intention of this International Standard to expand the application a

33、rea of some graphical symbols specified in ISO 15223 to the whole area of dentistry. Therefore these symbols are listed in this International Standard together with their source document. NOTE In addition to terms used in two of the three official ISO languages (English, French and Russian), this In

34、ternational Standard gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany (DIN). However, only the terms given in the official languages can be considered as ISO terms. 2 Normative references The following referenced documents

35、 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 639-1, Codes for the representation of names of languages Part 1: Alpha-2 code

36、ISO 1942, Dentistry Vocabulary ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 17724, Graphical symbols Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and in ISO 17724 app

37、ly. BS EN ISO 21531:2009ISO 21531:2009(E) 2 ISO 2009 All rights reserved4 Requirements 4.1 General Graphical symbols used to convey the information given in Clause 5 are given in this International Standard. For the user of this International Standard, in order to arrange all symbols necessary for d

38、ental products in one International Standard, some symbols defined by other International Standards are given for information purposes together with a reference to the respective International Standard. Each symbol may be used with a surrounding square. NOTE It is very common in dental practice for

39、symbols used in close proximity to each other to be individually enclosed by a surrounding shape (such as a square) in order to create a clear visual differentiation of where one symbol ends and another begins. 4.2 Use of graphical symbols These graphical symbols are intended to replace text, e.g. o

40、n the labels of dental devices and accessories. The use of symbols presented in the tables below is up to the discretion of the manufacturer. These symbols can be used for labelling of the packaging of dental devices and accessories, in the manufacturers instructions for use, in catalogues and leafl

41、ets and for similar purposes. The use of these symbols is possible without further explanation of the symbols in the accompanying text. 4.3 Size of symbols All graphical symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision without magn

42、ification at a distance that takes into account the specifics and size of the individual dental device and/or its package. NOTE 1 Colours and minimum dimensions are not specified in this International Standard. NOTE 2 The meaning of each graphical symbol may depend upon its orientation in a given re

43、ference system and care should be taken to avoid ambiguity (e.g. by rotating or mirroring). 4.4 Representation of names of languages and dates The language code used for the representation of names of languages is the two-letter code (alpha-2 code) in accordance with ISO 639-1. The data code used fo

44、r representation of dates is in accordance with ISO 8601. BS EN ISO 21531:2009ISO 21531:2009(E) ISO 2009 All rights reserved 35 Graphical symbols Table 1 Symbols for specific areas of dentistry N Symbol Title/description/application ISO/IEC registration No. 1 en: prophylaxis fr: prophylaxie de: Prop

45、hylaxe ISO 7000-2851 2 en: orthodontics fr: orthodontie de: Kieferorthopdie ISO 7000-2852 3 en: jaw surgery fr: chirurgie maxillo-faciale de: Kieferchirurgie ISO 7000-2853 4 en: implantology fr: implantologie de: Implantologie ISO 7000-2854 5 en: post system fr: systme pivot de: Aufbaustiftsystem IS

46、O 7000-2855 BS EN ISO 21531:2009ISO 21531:2009(E) 4 ISO 2009 All rights reservedTable 2 Symbols for working procedures used by dentists N Symbol Title/description/application ISO/IEC registration No. 6 en: cavity preparation fr: prparation de la cavit de: Kavittenprparation ISO 7000-2856 7 en: remov

47、al of old fillings fr: retrait de vieilles obturations de: Ausbohren alter Fllungen ISO 7000-2857 8 en: working on fillings fr: prparation dobturations de: Fllungsbearbeitung ISO 7000-2858 9 en: crown preparation fr: prparation coronaire de: Kronenprparation ISO 7000-2859 10 en: crown cutting fr: sp

48、aration des couronnes de: Kronentrennen ISO 7000-2860 11 en: root canal preparation fr: traitement endodontique de: Wurzelkanalaufbereitung ISO 7000-2861 12 en: root planing fr: surfaage radiculaire de: Wurzelglttung ISO 7000-2862 BS EN ISO 21531:2009ISO 21531:2009(E) ISO 2009 All rights reserved 5T

49、able 3 Symbols for working procedures used by dental technicians N Symbol Title/description/application ISO/IEC registration No. 13 en: precision technique fr: technique de prcision de: Feinwerktechnik ISO 7000-2863 14 en: mould casting technique fr: technique de coule de: Modellgusstechnik ISO 7000-2864 15 en: model fabrication fr: fabrication de modle de: Modellherstellung ISO 7000-2865 16 en: acrylic technique fr: technique acrylique de: Kunststofftechnik ISO 7000-2866 17 en: crown and bridge technique fr: