DIN EN ISO 21531-2009 Dentistry - Graphical symbols for dental instruments (ISO 21531 2009) English version of DIN EN ISO 21531 2009-08《牙科 牙科器械的图形符号(ISO 21531 2009) DIN EN ISO 2153.pdf

1、August 2009DEUTSCHE NORM English price group 11No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 01.080.20; 01.080.99; 1

2、1.060.01!$Y6“1541991www.din.deDDIN EN ISO 21531Dentistry Graphical symbols for dental instruments (ISO 21531:2009)English version of DIN EN ISO 21531:2009-08Zahnheilkunde Graphische Symbole fr Dentalinstrumente (ISO 21531:2009)Englische Fassung DIN EN ISO 21531:2009-08www.beuth.deDocument comprises

3、19 pagesDIN EN ISO 21531:2009-08 2 National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenaussch

4、uss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-04 AA Rotierende Instrumente. The DIN Standards corresponding to the International Standards referred to in the EN are as follows: ISO 1942 E DIN EN ISO 1942 ISO 8601 DIN ISO 8601 National Annex NA (informative) Bibliography E

5、 DIN EN ISO 1942, Dentistry Terminology DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21531 February 2009 ICS 11.060.01; 01.080.99 English Version Dentistry - Graphical symbols fo

6、r dental instruments (ISO 21531:2009) Art dentaire - Symboles graphiques pour instruments dentaires (ISO 21531:2009) Zahnheilkunde - Graphische Symbole fr Dentalinstrumente (ISO 21531:2008) This European Standard was approved by CEN on 21 January 2009. CEN members are bound to comply with the CEN/CE

7、NELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to a

8、ny CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions

9、. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

10、 Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Memb

11、ers. Ref. No. EN ISO 21531:2009: EContents 2 DIN EN ISO 21531:2009-08 EN ISO 21531:2009 (E) Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 Requirements.6 4.1 General .6 4.2 Use of graphical symbols.6 4.3 Size of symbols .6 4.4 Representation of names of

12、 languages and dates 6 5 Graphical symbols 7 Bibliography17 Foreword 3 EN ISO 21531:2009 (E) DIN EN ISO 21531:2009-08 This document (EN ISO 21531:2009) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry”, the secretariat of

13、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 by August 2009, and conflicting national standards shall be withdrawn at the latest by August 2009. Attention is drawn to the pos

14、sibility 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 patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries

15、are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sw

16、eden, 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. Introduction Graphical symbols are used in many areas of daily life. They give necessary and useful information of many kinds in a visual

17、way. They are used as signals (warning or alarm signals), for general information, as a means of control, for the correct application of machines, instruments, etc. and in may other ways of communication. Their content of information is very often superior to verbal explanations because their inform

18、ation is visually acknowledged instantly and is often kept in memory easier and longer than terms or phonetic explanations. Graphical symbols are internationally understandable without sometimes difficult, possibly misleading and costly translations. Each ISO technical committee is responsible for t

19、he selection or creation of graphical symbols within its own field of interest. Graphical symbols may form the main subject 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

20、ISO Technical Management Board has assigned overall responsibility for standardization in the field of graphical symbols to 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 devic

21、es, which is responsible for the development of ISO 15233, has prepared an international guide to the development and registration of symbols for use in the labelling of medical devices. This guideline recommends that the proliferation of graphical symbols without international harmonization is unde

22、sirable and contrary to these objectives. There is a need for simple, internationally accepted graphical symbols labelling that 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,

23、dentists, dental technicians and other persons, to reduce the confusion inherent in the use of multiple language labelling. 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 th

24、e use of specific symbols is best taken up by bodies expert in the relevant areas. ISO/TC 106/SC 4/WG 5, Number coding system, has taken up this responsibility by developing this International Standard. This International Standard has been prepared to reduce the need for multiple translations of wor

25、ds into national languages, to simplify labelling whereever possible and to prevent separate development of different symbols 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 lite

26、rature, for the labelling and packaging of devices used in dentistry, on items of dental equipment and instruments. Their use is unlimited and a most helpful means of communication within dentistry. 4 DIN EN ISO 21531:2009-08 EN ISO 21531:2009 (E) 1 Scope This International Standard presents a serie

27、s of graphical 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 be

28、en added. Because 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 ap

29、plication area 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 Russia

30、n), this International 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 reference

31、d 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 document (including any amendments) applies. ISO 639-1, Codes for the representation of names of languages Part 1: Al

32、pha-2 code 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 IS

33、O 17724 apply. 5 EN ISO 21531:2009 (E) DIN EN ISO 21531:2009-08 4 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 dental pr

34、oducts 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 symbols

35、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. on the la

36、bels 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 leaflets and

37、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 magnificatio

38、n 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 reference

39、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 for repres

40、entation of dates is in accordance with ISO 8601. 6 DIN EN ISO 21531:2009-08 EN ISO 21531:2009 (E) 5 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: Prophylaxe ISO 7000-2851 2 en:

41、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 ISO 7000-2855 7 EN ISO 21531:

42、2009 (E) DIN EN ISO 21531:2009-08 Table 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: removal of old fillings fr: retrait de vieilles obt

43、urations 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: sparation des couronnes de: Kronentrennen ISO 70

44、00-2860 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 8 DIN EN ISO 21531:2009-08 EN ISO 21531:2009 (E) Table 3 Symbols for working procedures used by dental technicians

45、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: Model

46、lherstellung ISO 7000-2865 16 en: acrylic technique fr: technique acrylique de: Kunststofftechnik ISO 7000-2866 17 en: crown and bridge technique fr: technique des couronnes et bridges de: Kronen- und Brckentechnik ISO 7000-2867 9 EN ISO 21531:2009 (E) DIN EN ISO 21531:2009-08 Table 4 Symbols for cl

47、eaning, disinfection and sterilization N Symbol Title/description/application ISO/IEC registration No.18 en: ultrasonic bath fr: bain ultrasons de: Ultraschallbad ISO 7000-2784 19 en: washer-disinfector for thermal disinfection fr: laveur-dsinfecteur pour dsinfection thermiquede: Reinigungs-/Desinfe

48、ktionsgert fr die thermische Desinfektion ISO 7000-2785 20 In the symbol a number shall be inserted indicating the specified temperature. NOTE The temperature of 134 C is given only as an example. en: sterilizable in a steam sterilizer (autoclave) at the temperature specified fr: strilisable dans un

49、 strilisateur vapeur deau (autoclave) la temprature spcifie de: sterilisierbar im Dampf-Sterilisator (Autoklav) bei der angegebenen Temperatur ISO 7000-2868 21 In the symbol a number shall be inserted indicating the specified temperature. NOTE The temperature of 180 C is given only as an example. en: sterilizable up to the temperature specified fr: strilisable la temprature spcifie de: sterilisierbar bei der angegebenen TemperaturISO 7000-1844 22 en: sterile fr: strile de: steril ISO 7000-2499 10 DIN E