BS EN ISO 9873-2017 Dentistry Intra-oral mirrors《牙科 内窥镜》.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry Intra-oral mirrorsBS EN ISO 9873:2017National forewordThis British Standard is the UK implementation of EN ISO 9873:2017. It supersedes BS EN ISO 9873:2000, which is withdrawn.The UK participation in its prepa

2、ration 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

3、its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 86884 9ICS 11.060.25; 11.060.20Compliance 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 31 May 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS EN ISO 9873:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 9873May 2017ICS 11.060.20 Supersedes EN ISO 9873:2000EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT

5、EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 9873:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry Intra-oral mirrors (ISO 9873:2017)

6、Mdecine bucco-dentaire Miroirs endobuccaux (ISO 9873:2017) Zahnheilkunde Intraoralspiegel (ISO 9873:2017) This European Standard was approved by CEN on 9 February 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European St

7、andard 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 Management Centre or to any CEN member.This European Standard exists in three official versions (Engli

8、sh, 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 status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bu

9、lgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switz

10、erland, Turkey and United Kingdom.English VersionEN ISO 9873:2017 (E)European forewordThis document (EN ISO 9873:2017) has been prepared by 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

11、 Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2017, and conflicting national standards shall be withdrawn at the latest by November 2017.Attention is drawn to the possibility that some of the elemen

12、ts 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 9873:2000.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following c

13、ountries 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

14、 Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 9873:2017 has been approved by CEN as EN ISO 9873:2017 without any modification.iiBS EN ISO 9873:2017ISO 9873:2017(E)Foreword ivIntroduction v1 Scope .

15、12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Dimensions . 24.1.1 Overall length 24.1.2 Connection between the stem and handle, if applicable . 34.1.3 Dimensions of mirror casing and viewing surface . 34.1.4 Mirror head size designation 34.1.5 Position of mirror head with r

16、espect to the stem . 44.2 Materials . 54.2.1 Mirror glass 54.2.2 Mirror casing . 54.2.3 Mirror handle 54.3 Other requirements 54.3.1 Casing of mirror head 54.3.2 Reflecting surfaces . 54.3.3 Nominal magnification . 54.3.4 Casing/stem joint strength . 64.3.5 Handle . 64.4 Resistance to reprocessing .

17、 65 Measurement and test methods . 65.1 Visual inspection . 65.2 Resistance to reprocessing . 65.3 Determination of nominal magnification for magnifying mirrors . 65.3.1 Apparatus . 65.3.2 Procedure . 75.4 Distortion . 75.4.1 Apparatus . 75.4.2 Procedure . 75.5 Casing/stem joint strength test 85.5.1

18、 Apparatus . 85.5.2 Procedure . 96 Marking 96.1 General . 96.2 Mirror head 96.3 Mirror handle . 96.4 Package . 10Bibliography .11 ISO 2017 All rights reserved iiiContents PageBS EN ISO 9873:2017ISO 9873:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation

19、 of national standards bodies (ISO member bodies). The work of 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.

20、International organizations, governmental and non-governmental, 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.The procedures used to develop this document and those

21、 intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different 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 (se

22、e http:/www.iso.org/directives).Attention 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. Details of any patent rights identified during the development of the

23、 document will be in the Introduction and/or on the ISO list of patent declarations received (see http:/www.iso.org/patents).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 voluntary nature of sta

24、ndards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by ISO/TC 106, Dentis

25、try, Subcommittee SC 4, Dental instruments.This third edition cancels and replaces the second edition (ISO 9873:1998), which has been technically revised. It also incorporates the Technical Corrigendum ISO 9873:1998/Cor.1:2000. The following changes have been made: deletion of the limitation to meta

26、llic mirror cases and handles; replacement of water and dry heat test by reprocessing test; deletion of hollow-handle leak test.iv ISO 2017 All rights reservedBS EN ISO 9873:2017ISO 9873:2017(E)IntroductionThis document specifies requirements for a type of dental viewing and retracting instrument in

27、 common use throughout the world.However, it is well known that there are also other types of intra-oral mirrors in use which have different designs and/or are made of different materials. Amongst these other types are mirrors with a polished metal reflecting surface (as opposed to a coated glass su

28、rface).Standardization of these other types may form the subject of future work. ISO 2017 All rights reserved vBS EN ISO 9873:2017This page deliberately left blankDentistry Intra-oral mirrors1 ScopeThis document specifies requirements and test methods for reusable intra-oral mirrors with a coated gl

29、ass reflecting surface used for dental purposes in the oral cavity.In addition, specific requirements for metallic casing and metallic handles are given.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements

30、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 263, ISO inch screw threads General plan and selection for screws, bolts and nuts Diameter range 0,06 to 6 inISO 724, I

31、SO general-purpose metric screw threads Basic dimensionsISO 965-1, ISO general purpose metric screw threads Tolerances Part 1: Principles and basic dataISO 1942, Dentistry VocabularyISO 5864, ISO inch screw threads Allowances and tolerances3 Terms and definitionsFor the purposes of this document, th

32、e terms and definitions given in ISO 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp3.1intra-o

33、ral mirrormouth mirrorhandheld dental instrument for intra-oral inspection or inspection and retraction generally comprising the mirror head and the mirror handleNote 1 to entry: See Figure 1.3.2mirror headassembly comprising a glass reflective surface, casing, packing (if present) and stem3.3stempa

34、rt of the intra-oral mirror connecting the reflecting surface to the handle3.4reflecting surfacelayer applied to the mirror glass for the purpose of reflecting lightINTERNATIONAL STANDARD ISO 9873:2017(E) ISO 2017 All rights reserved 1BS EN ISO 9873:2017ISO 9873:2017(E)3.5reflecting back surfacerefl

35、ecting layer coated onto the back surface of the mirror glass so that the image can be observed through the glass3.6reflecting front surfacereflecting layer coated onto the front surface of the mirror glass so that the image can be observed with no intervening glass layer3.7plane mirrorintra-oral mi

36、rror whose reflective surface is flat3.8magnifying mirrorintra-oral mirror whose reflective surface is concave to produce an enlarged image of the object observed3.9viewing surfacesurface of the mirror glass, excluding the bevel, not enclosed by the metal casing3.10distortionimage deformation due to

37、 optical defect(s) Key1 handle2 stem3 mirror head4 reflecting surfaceFigure 1 Designation for intra-oral mirror parts4 Requirements4.1 Dimensions4.1.1 Overall lengthThe maximum length is at the manufacturers discretion but it should be noted that overall lengths in excess of 178 mm may cause difficu

38、lty in containment within a sterilization cassette.2 ISO 2017 All rights reservedBS EN ISO 9873:2017ISO 9873:2017(E)4.1.2 Connection between the stem and handle, if applicable4.1.2.1 One-piece design (not applicable)This requirement is not applicable to intra-oral mirrors with a one-piece design.4.1

39、.2.2 Two-piece design (applicable)4.1.2.2.1 Metric thread connectionThe dimensions of the connection between the stem and handles shall be M 2,5 in accordance with ISO 724. The tolerances for the stem shall be 6e and for the handle 6H, in accordance with ISO 965-1. The length of the thread engagemen

40、t shall be as shown in Figure 2.4.1.2.2.2 Imperial thread connectionThe dimensions of the connection between the stem and handles shall be imperial thread No. 4-48 UNF, in accordance with ISO 263. The length of the thread engagement shall be as shown in Figure 3.The tolerances for the stem shall be

41、2A and for the handle 2B, in accordance with ISO 5864.4.1.3 Dimensions of mirror casing and viewing surfaceMouth mirrors shall meet the dimensions given in Figure 2, Figure 3, and Table 1.4.1.4 Mirror head size designationThe mirror head size designations are based on the nominal diameter of the cas

42、ing, d1, expressed in millimetres. Each subsequent size increases by 2 mm.Table 1 Mirror head and viewing surfaceDimensions in millimetresSize designation Preferred sizes and designation: Nominal head diameter d1Nominal viewing surface d200 12 d1 2,5 mm max.0 14 d1 2,5 mm max.1 16 d1 2,5 mm max.2 18

43、 d1 2,5 mm max.3 19, 20 d1 2,5 mm max.4 21, 22 d1 2,5 mm max.5 24 d1 2,5 mm max.6 26 d1 3 mm max.7 28 d1 3 mm max.8 30 d1 3 mm max. ISO 2017 All rights reserved 3BS EN ISO 9873:2017ISO 9873:2017(E)Dimensions in millimetresKeyaWhen assembled (recommended overall length).Figure 2 Intra-oral mirror wit

44、h metric thread connectionDimensions in millimetresKeyaWhen assembled (recommended overall length).Figure 3 Intra-oral mirror with imperial thread connection4.1.5 Position of mirror head with respect to the stemThe mirror head shall be positioned such that the long axis of the stem bisects the casin

45、g to provide a symmetrical mount about the plane surface of the mirror glass/casing.Test in accordance with 5.1.4 ISO 2017 All rights reservedBS EN ISO 9873:2017ISO 9873:2017(E)4.2 Materials4.2.1 Mirror glassThe mirror glass shall be made of polished glass free from visible defects such as waves, ch

46、ips, scratches and other imperfections observable to the naked eye. Test in accordance with 5.1.4.2.2 Mirror casing4.2.2.1 Metallic mirror casingThe mirror casing shall be made of metal which is resistant to corrosion, e.g. stainless steel or a plated non-ferrous alloy.Examples of suitable stainless

47、 steel or other metal alloys can be found in ISO 7153-1.4.2.2.2 Plastic mirror casingThe material is left to the discretion of the manufacturer provided that it complies with the requirements of this document.4.2.3 Mirror handle4.2.3.1 Metallic mirror handleMirror handles shall be made of metal whic

48、h is resistant to corrosion, e.g. stainless steel or a plated non-ferrous alloy.Examples of suitable stainless steel or other metal alloys can be found in ISO 7153-1.4.2.3.2 Plastic mirror handlesThe material for the plastic mirror handle is left to the discretion of the manufacturer provided that i

49、t complies with the requirements of this document.4.3 Other requirements4.3.1 Casing of mirror headThe casing shall have a formed edge which shall be below the level of the viewing surface of the glass and shall be visibly free from burrs, flash or other irregularities. Test in accordance with 5.1.4.3.2 Reflecting surfacesThe reflecting surfaces shall allow the image without deformation to be viewed through, or from, the whole of the viewing surface. Test in accordance with 5.1.4.3.3 Nominal magnification