EN ISO 9687-2015 en Dentistry - Graphical symbols for dental equipment (Incorporates Amendment A1 2018)《牙科学 牙科设备的图形符号(ISO 9687 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 9687:2015Dentistry Graphical symbols for dental equipmentBS EN ISO 9687:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 9687:2015. It supersedes BS EN ISO 9687:1996 which is withdrawn.The UK participation in its prepar

2、ation was entrusted to Technical Committee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for i

3、ts correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 78986 1 ICS 01.080.20; 11.060.20 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standa

4、rds Policy and Strategy Committee on 28 February 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9687 February 2015 ICS 01.080.20; 11.060.20 Supersedes EN ISO 9687:1995English Version Dentistry - Graphical symbol

5、s for dental equipment (ISO 9687:2015) Mdecine bucco-dentaire - Symboles graphiques pour matriel dentaire (ISO 9687:2015) Zahnheilkunde - Graphische Symbole fr zahnrztliche Ausrstungen (ISO 9687:2015) This European Standard was approved by CEN on 29 November 2014. CEN members are bound to comply wit

6、h the CEN/CENELEC 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-CENELEC Manag

7、ement Centre or to any 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-CENELEC Management Centre has the same sta

8、tus as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malt

9、a, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN

10、 All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9687:2015 EBS EN ISO 9687:2015EN ISO 9687:2015 (E) 3 Foreword This document (EN ISO 9687:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with T

11、echnical 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 by August 2015, and conflicting national standards shall be withdrawn

12、 at the latest by August 2015. 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 patent rights. This document supersedes EN ISO 9687:1995. According to

13、 the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece

14、, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 9687:2015 has been approved by CEN as EN ISO 9687:2015 without a

15、ny modification. BS EN ISO 9687:2015ISO 9687:2015(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 14.1 General . 14.2 Use of graphical symbols 24.3 Size of symbols 24.4 Representation of names of languages and dates . 25 Graphical

16、symbols . 2Bibliography .28 ISO 2015 All rights reserved iiiBS EN ISO 9687:2015ISO 9687:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carrie

17、d 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 part in the work. IS

18、O collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different

19、approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be

20、the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

21、Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in

22、 the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 6, Dental equipment.This second edition cancels and replaces the first edition (ISO 9687:1993), which has been techn

23、ically revised with the following changes: addition of ISO/IEC registration number; addition of Table 2: symbols for cleaning, disinfection and sterilization; addition of Table 3: symbols for disinfectants used for hygienic purposes; addition of Table 4: symbols for miscellaneous.iv ISO 2015 All rig

24、hts reservedBS EN ISO 9687:2015ISO 9687:2015(E)IntroductionGraphical 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 means of control, for the corr

25、ect application of machines, instruments, etc. and in many 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 explanat

26、ions.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 can form the main subj

27、ect of an International Standard, or a single symbol or several symbols might 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 symbol

28、s to ISO/TC 145, Graphical symbols, and to ISO/TC 10/SC 10, Technical product documentation (tpd) symbols.ISO/TC 210 who is responsible for the development of ISO 15233, prepared an international guide to the development and registration of symbols for use in the labelling of medical devices. This g

29、uideline 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 that provides general and specific information to the user in a manner

30、that overcomes the limitations of languages. It is in the best interest of safety and health of patients, 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 symbol

31、s 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 6/WG 2, Dental patient chair and dental unit, has taken up this responsibility by developing this

32、 International Standard.This International Standard has been prepared to reduce the need for multiple translations of words into national languages, to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information.This International Stan

33、dard contains a series of symbols (pictograms) for use in dentistry. Their application should be considered in literature 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 withi

34、n dentistry. ISO 2015 All rights reserved vBS EN ISO 9687:2015BS EN ISO 9687:2015Dentistry Graphical symbols for dental equipment1 ScopeThis International Standard specifies graphical symbols for dental equipment. It is intended that the symbols are to be used on the appropriate piece of dental equi

35、pment and in documents pertaining to dental equipment, for example in instructions for use, marking, labelling, and technical product documentation.The symbols are selected specifically for all kinds of dental equipment. The majority of the symbols are taken from relevant ISO, IEC, or other internat

36、ional documents. Several new symbols presented by manufacturers or users have been added.NOTE In addition to terms used in two of the three official ISO languages (English, French, and Russian), this International Standard gives the equivalent terms in the German language; these are published under

37、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 referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. F

38、or 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 codeISO 1942, Dentistry VocabularyISO 8601, Data elements and in

39、terchange formats Information interchange Representation of dates and timesISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsISO 17724, Graphical symbols Vocabulary3 Terms and definitionsFor the purpo

40、ses of this document, the terms and definitions given in ISO 1942, ISO 15223-1 and ISO 17724 apply.4 Requirements4.1 GeneralGraphical symbols used to convey the information given in Clause 5 are given in this International Standard.In order to arrange for the user of this International Standard all

41、symbols necessary for dental equipment are shown in this International Standard. Therefore, some symbols defined by other International Standards are given for information purposes together with a reference to the respective International Standard.INTERNATIONAL STANDARD ISO 9687:2015(E) ISO 2015 All

42、 rights reserved 1BS EN ISO 9687:2015ISO 9687:2015(E)4.2 Use of graphical symbolsThese graphical symbols are intended to replace text, e.g. on the labels of dental equipment and accessories. The use of symbols presented in the tables below is up to the discretion of the manufacturer. These symbols c

43、an be used for labelling of the packaging of dental equipment and accessories, in the manufacturers instructions for use, in catalogues and leaflets 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 symbolsA

44、ll graphical symbols and accompanying information shall be legible when viewed under an illumination of 215 lx using normal vision without magnification at a distance, which takes into account the specifics and size of the individual dental equipment and/or its package.NOTE Colours and minimum dimen

45、sions are not specified in this International Standard.The meaning of each graphical symbol may depend upon its orientation in a given reference system and care should be taken to avoid ambiguity (e.g. by rotating or mirroring).4.4 Representation of names of languages and datesThe language code used

46、 for the representation of names of languages shall be the two-letter code (alpha-2 code) in accordance with ISO 639-1.The data code used for representation of dates shall be in accordance with ISO 8601.5 Graphical symbolsTable 1 Graphical symbols for dental equipmentNo. Title of symbol SymbolISO/IE

47、C registration no.1en: dental patient chair, generalfr: fauteuil dentaire, en gneralde: Zahnrztlicher Patientenstuhl, allgemeinISO 7000-18192en: dental patient chair, rotaryfr: rotation du fauteuil dentairede: Zahnrztlicher Patientenstuhl, drehenISO 7000-18203en: dental operators stoolfr: sige dopra

48、teur dentairede: Zahnrztlicher ArbeitsstuhlISO 7000-18214en: dental operating lightfr: appereil dclairage opratoire den-tairede: Zahnrztliche BehandlungsleuchteISO 7000-18222 ISO 2015 All rights reservedBS EN ISO 9687:2015ISO 9687:2015(E)No. Title of symbol SymbolISO/IEC registration no.5en: dental

49、unitfr: unit dentairede: Zahnarzt-ElementISO 7000-18236en: assistants unitfr: unit de lassistant(e)de: Assistenz-ElementISO 7000-18247en: spittoon, cuspidorfr: crachoirde: MundsplbeckenISO 7000-18258en: spittoon with water fountainfr: crachoir avec fontainede: Mundsplbecken mit MundglasfllerISO 7000-18269en: sink cabinetfr: lavabo encastrde: WaschbeckenschrankISO 7000-182710en: dental cabinetfr: meuble dentairede: Schrank, dentalerISO 7000-182811en: handpiece, air turbinefr: pice main, turbine airde: Handstck, L