EN ISO 21671-2006 en Dentistry - Rotary polishers (Incorporates Amendment A1 2011)《牙科学 旋转抛光器 ISO 21671-2006》.pdf

1、BRITISH STANDARD BS EN ISO 21671:2006 Dentistry Rotary polishers ICS 11.060.20+A1:2011National foreword This British Standard is the UK implementation of EN ISO 21671:2006+A1:2011. It is identical with ISO 21671:2006, incorporating amendment 1:2011. It supersedes BS EN ISO 21671:2006, which is withd

2、rawn. The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by !“. The UK participation in its preparation was entrusted by

3、 Technical Committee CH/106, Dentistry, to Subcommittee CH/106/4, Dental instruments. A list of organizations represented on this subcommittee 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 f

4、or its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN ISO 21671:2006+A1:2011 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2011 Amendments/corrigenda issued si

5、nce publication Date Comments 31 July 2011 Implementation of ISO amendment 1:2011, with CEN endorsement A1:2011. ISBN 978 0 580 65536 4EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21671:2006+A1 ICS 11.060.20 English Version Dentistry - Rotary polishers (ISO 21671:2006) Art dentaire - Pol

6、issoirs rotatifs (ISO 21671:2006)Z ahnheilkunde - Rotierende Polierer (ISO 21671:2006) This European Standard was approved by CEN on 26 June 2006 . CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of

7、 a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A versio

8、n in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions . CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estoni

9、a, Finland, France, 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPI

10、SCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members . Ref. No. EN ISO 21671:2006: E May 2011Foreword This document (EN ISO 21671:2006) has been prepared by Technic

11、al Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC5 5 “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 texto r by endorsement, at the latestb y Januar

12、y2 007, and conflicting national standards shall bew ithdrawn at the latest by January2 007. According to the CEN/CENELEC Internal R egulations, the national standards organizations o f the following countries are bound to implement this European Standard: Austria, Belgium , Cyprus, Czech Republic,

13、Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 21671:2006 has been approv

14、ed by CEN as EN ISO 21671:2006 without any modifications. Foreword to amendment A1 This document (EN ISO 21671:2006/A1:2011) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is

15、 held by DIN. This Amendment to the European Standard EN ISO 21671:2006 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2011, and conflicting national standards shall be withdrawn at the latest by November 2011

16、. 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. According to the CEN/CENELEC Internal Regulations, the national standards organizati

17、ons of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal

18、, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21671:2011/Amd 1:2011 has been approved by CEN as a EN ISO 21671:2006/A1:2011 without any modification. BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)Reference number ISO

19、21671:2006(E) INTERNATIONAL STANDARD ISO 21671 First edition 2006-07-15 Dentistry Rotary polishers Art dentaire Polissoirs rotatifs ii iii Contents Page Foreword iv Introduction v 1S cope . 1 2N ormative references . 1 3T erms, definitions and symbols 1 3.1 Terms and definitions. 1 3.2 Symbols .2 4R

20、 equirements 2 4.1 Materials 2 4.2 Shapes . 2 4.3 Dimensions 2 4.4 Colour codes for marking of grit sizes for diamond-containing abrasives 3 4.5 Run-out 3 5U nmounted polishers. 4 5.1 Disc. 4 5.2 Lens 5 5.3 Cylindrical for screw-in. . 5 5.4 Conical for screw-in, truncated conical 6 5.5 Cylindrical f

21、or screw-in, end conical 6 5.6 Cylindrical, plain . 7 5.7 Inverted conical, recessed cylindrical end 7 5.8 Inverted conical, recessed conical end 8 6M ounted polishers 8 6.1 Cylindrical 8 6.2 Disc. 9 6.3 Wheel 9 6.4 Spherical 10 6.5L ens 10 6.6T orpedo, conical . 11 6.7 Cylindrical, end hemispherica

22、l 11 6.8 Bullet, tapered with round end. . 12 6.9T orpedo, cylindrical 12 6.10 Bud, slender. . 13 6.11 Inverted conical, recessed conical end, with collar 13 6.12 Inverted conical, recessed conical end 14 6.13 Inverted conical, conical pointed 14 7T est procedures 15 7.1S hape . 15 7.2D imensions 15

23、 7.3 Run-out 15 8S ampling and acceptance quality limit (AQL) . 15 9M arking 15 10 Labelling 15 11 Packaging 15 Bibliography. 16 BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standa

24、rds bodies (ISO m ember b odies). T he work o f preparing I nternational Standards is n ormally carried o ut t hrough I SO technical committees. Each member bodyi nterested in a subject for which a technical committee has been established has the right to be represented on that committee. Internatio

25、nal organizations, governmental and non-governmental, in liaison with I SO, also t ake part in the work. ISO c ollaborates c loselyw ith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the

26、rules given in the ISO/IEC Directives, Part 2 . The main task of t echnical committees i s to prepare International S tandards. Draft International Standards adopted by t he technical c ommittees a re c irculated t o the member b odies f or v oting. P ublication as an International Standard requires

27、 approval by at least 75 % of the member bodies casting a vote. 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. ISO 21671 was p repared by T echnical

28、 Committee ISO/TC1 06, Dentistry , Subcommittee SC 4, Dental instruments. BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)v Introduction This International Standard is one of a series of standards relating to rotary instruments used in dentistry. The various d imensional a nd other r equir

29、ements s pecified for polishers are those c onsidered i mportant t o ensure the interchangeability and safe usage of these instruments in the dental laboratorya nd at the dentists working place. The nominal diameters of t he working part listed in Clauses 5 and 6 comply preferablyw ith the diameters

30、 specified in ISO 2157. Attention is drawn to ISO6 360 which specifies a 15-digit number coding system for the identification of rotary instruments of all types used in dentistry. BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)blank1 Dentistry Rotary polishers 1 Scope This I nternational

31、Standard specifies t he dimensions a nd other r equirements f or t he most c ommonly used polishersw hich are used at the working place of the dentist and/or in the dental laboratory. This International Standard is applicable to unmounted and mounted polishers. 2 Normativer eferences The following r

32、eferenced d ocuments a re i ndispensable for the application of t his d ocument. For dated references, only the edition cited applies. For undated references, the latest edition of t he r eferenced document (including any amendments) applies . ISO 1797-1:1992, Dental rotary instruments Shanks Part 1

33、: Shanks made of metals ISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks made of plastics ISO 1942, Dentistry Vocabulary ISO 2859-1, Sampling p rocedures f or i nspection by a ttributes P art1 : Sampling schemes i ndexed b y acceptance quality limit (AQL) for lot-by-lot inspection ISO 636

34、0-1, Dentistry Number coding system for rotary instruments Part 1: General characteristics ISO 6360-2, Dentistry Number coding system for rotary instruments P art2 :S hapes ISO 6360-6, Dentistry N umber coding system for rotary instruments Part 6: Specific characteristics of abrasive instruments ISO

35、 8325, Dentistry Test methods for rotary instruments ISO 13295, Dentistry Mandrels for rotary instruments 3 Terms, definitions and symbols 3.1T erms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply . 3.1.1 polisher rotary instrume

36、nt used in dentistryf or polishing dental materials or teeth 3.1.2 mounted polisher nondetachable polisher that is fixed on a shank ISO 7711-3, Dentistry Diamond rotary instruments Part 3: Grit sizes, designation and colour code! “ BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)2 3.1.3 un

37、mounted polisher polisher that is delivered without a fixture or shank, but which is to be mounted on a fixture o r mandrel with a fixture or a screw 3.2 Symbols For the purpose of this document the following symbols apply: d 1 diameter of working part, head diameter; d n diameter as appropriate (se

38、e Figures 1 to 21); l 1 length of working part; l n length as appropriate (see Figures 1 to 21); 1 angle of working part; 2 angle of screw-in orifice; n a ngle as appropriate. 4 Requirements 4.1 Materials 4.1.1 Working part The working part shall be made of silicon rubber, natural rubber or syntheti

39、c rubber with the possible addition of abrasive materials. The selection of the type of material and its treatment shall be at the discretion of the manufacturer . 4.1.2 Shank or mandrel The material of the shank for mounted polishers shall comply with ISO 1797-1 or ISO 1797-2. The material of the m

40、andrel used f or u nmounted polishers shall comply with ISO 13295. The material of mandrels not specified shall be at the discretion of the manufacturer . 4.2 Shapes The shapes of the working part shall be as specified in Figures 1 to 21. Variations o f the shapes within the limited dimensions a nd

41、the description used i n the subclause titles are permitted. Sharp or slightlyr ounded edges are at the discretion of the manufacturer . Testing shall be carried out in accordance with 7.1. 4.3 Dimensions Dimensions are given in millimetres, angles in degrees . BS EN ISO 21671:2006+A1:2011 EN ISO 21

42、671:2006+A1:2011 (E)3 4.3.1 Working part The dimensions of the working part shall be as specified in the appropriate Tables in Clauses 5 and 6. Testing shall be carried out in accordance with 7.2. 4.3.2 Shanks and mandrels 4.3.2.1 Mountedp olishers The shank of mounted polishers shall be either Type

43、 1, Type 2, Type 3 or Type 4 of ISO 1797-1:1992. Screw threaded shanks shall be 1,80 mm diameter with 0,35 mm thread pitch or with 0,40 mm thread pitch. 4.3.2.2 Unmountedp olishers Mandrels for unmounted polishers shall be in acc ordance with ISO 13295. 4.4C olour codes for marking of grit sizes for

44、 diamond-containing abrasives The application of the colour code is left to the discretion of the manufacturer . If colour coding is applied, it shall be performed as described in this International Standard. Take account of the fitting length of the shank according to ISO1 797-1 and to ISO 1797-2.

45、Position of colour coding: on the shank, next to thew orking part. Colour coding for marking of grit sizes for diamond-containing abrasives shall be in accordance with ISO 7711-3. ! “ Table 1 Colour code for grit sizes of diamond-containing abrasives Grit size of abrasives in the working part Abbrev

46、iation Colour of ring marking Ultra fine UF White Extra fine EF Yellow Fine F Red Medium M Blue Coarse C Green Very coarse VC Black 4.5 Grit sizes for polishing instruments Grit sizes for polishing instruments shall be as specified in Table 2. Table 2 Grit sizes for polishing instruments Grit size d

47、esignation Diamond grit Other grits (e.g. corundum carbide) Name Abbreviation Grit size m Grit designation (e.g. FEPA) Grit size m Grit designation (e.g. FEPA) Ultra fine UF 1 to 4 M1 to M4 F1200 Extra fine EF 4 to 8 M4 to M8 3 to 8 F1000 Fine F 8 to 32 M8 to M32 6,5 to 12,8 F800 to F500 Medium M 32

48、 to 69 M32 to D76 22,8 to 75 F360 to F220 Coarse C 69 to 164 D76 to D181 63 to 150 F180 to F100 Very coarse VC 164 D181 150 F100 BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)4 5 Unmounted polishers 5.1 Disc Figure 1 Disc Table 3 Disc Dimensions and run-out Designation of nominal diamete

49、r, nominal size d 1 0,5 d 2 0,2 l 1 0,3 Run-out 120 12 2,0 170 17 2,5 200 20 1,0 220 22 1,0 220 22 3,1 250 25 1,0 260 26 1,8 1,2 0,2 4. Run-out The run-out shall be as given in the respective Tables in Clauses 5 and 6. Testing shall be carried out in accordance with 7.3. ! “ 6 ! “ BS EN ISO 21671:2006+A1:2011 EN ISO 21671:2006+A1:2011 (E)5 5.2 Lens a Edge: sharp or slightly rounded at the discretion of the manufacturer. Figure 2 Lens Table 4 Lens Dimensions and run-out Designa