BS EN ISO 3630-4-2009 Dentistry - Root canal instruments - Part 4 Auxiliary instruments (ISO 3630-4 2009)《牙科 牙根槽仪器 第4部分 辅助仪器(ISO 3630-4-2009)》.pdf

1、BS EN ISO3630-4:2009ICS 11.060.25NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Root canalinstrumentsPart 4: Auxiliary instruments (ISO3630-4:2009)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31

2、 July 2009 BSI 2009ISBN 978 0 580 59575 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 3630-4:2009National forewordThis British Standard is the UK implementation of EN ISO 3630-4:2009.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental

3、Instruments 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 cann

4、ot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 3630-4July 2009ICS 11.060.20English VersionDentistry - Root canal instruments - Part 4: Auxiliary instruments(ISO 3630-4:2009)Art dentaire - Instruments pour canaux radiculaires - Partie4: Instruments auxi

5、liaires (ISO 3630-4:2009)Zahnheilkunde - Wurzelkanalinstrumente - Teil 4:Hilfsinstrumente (ISO 3630-4:2009)This European Standard was approved by CEN on 20 June 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStand

6、ard the status of a national standard without 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,

7、German). A version in any other language 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

8、Republic, 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.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE

9、 NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement 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 3630-4:2009: EBS EN ISO 3630-4:2009EN ISO 3630-4:2009 (E) 3 Foreword This docum

10、ent (EN ISO 3630-4:2009) 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 Standard shall be given the status of a national standard, either by publication of an ident

11、ical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by January 2010. 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

12、responsible for identifying any or all such patent 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,

13、France, Germany, Greece, Hungary, Iceland, Ireland, 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 3630-4:2009 has been approved by CEN as a EN ISO

14、3630-4:2009 without any modification. BS EN ISO 3630-4:2009ISO 3630-4:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Terms, definitions and symbols 1 3.1 Terms and definitions. 1 3.2 Symbols . 2 4 Classification. 2 5 Requirements 3 5.1 Mate

15、rial 3 5.2 Dimensions 3 5.3 Colour designation and size marking with rings. 6 5.4 Mechanical requirements. 7 5.5 Resistance to corrosion. 9 5.6 Heat effects of sterilization 9 6 Sampling 9 7 Testing . 9 7.1 General. 9 7.2 Dimensions 9 8 Designation, marking and identification 10 9 Packaging 10 10 La

16、belling 10 Bibliography . 11 BS EN ISO 3630-4:2009ISO 3630-4:2009(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 Standards is normally

17、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 part in the wo

18、rk. 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 to prepare Inte

19、rnational 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 that some of t

20、he 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 3630-4 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. ISO 3630 consists of the following parts, un

21、der the general title Dentistry Root canal instruments: Part 1: General requirements and test methods Part 2: Enlargers Part 3: Condensers, pluggers and spreaders Part 4: Auxiliary instruments The following part is under preparation: Part 5: Shaping and cleaning instruments BS EN ISO 3630-4:2009INTE

22、RNATIONAL STANDARD ISO 3630-4:2009(E) ISO 2009 All rights reserved 1Dentistry Root canal instruments Part 4: Auxiliary instruments 1 Scope This part of ISO 3630 specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures not cited i

23、n ISO 3630-1, 3630-2, 3630-3 or 3630-5. This part of ISO 3630 specifies requirements for size, product designation, safety considerations, instructions and labelling. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated reference

24、s, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of metals ISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks made of plastics ISO 194

25、2, Dentistry Vocabulary ISO 3630-1:2008, Dentistry Root-canal instruments Part 1: General requirements and test methods ISO 3630-2:2000, Dental root-canal instruments Part 2: Enlargers 3 Terms, definitions and symbols 3.1 Terms and definitions For the purposes of this document, the terms and definit

26、ions given in ISO 1942, ISO 3630-1 and the following apply. 3.1.1 barbed broach root-canal instrument with barbs designed for removing the pulp tissue 3.1.2 rasp root-canal instrument in which sharp prominences have been formed on the working part and which is designed to enlarge a root canal by abr

27、asive action 3.1.3 paste carrier root-canal instrument designed for conveying filling material or medicaments into a root canal BS EN ISO 3630-4:2009ISO 3630-4:2009(E) 2 ISO 2009 All rights reserved3.1.4 root-canal explorer root-canal instrument designed for exploring the root canal system 3.1.5 cot

28、ton broach root-canal instrument used with cotton for drying root canals or placing medicaments 3.1.6 height of barb height measured perpendicularly from the outside of the core to the barbed tip 3.1.7 core diameter of the instrument diameter of the solid portion of the barbed broach or rasp 3.2 Sym

29、bols For the purposes of this document, the following symbols apply. d1diameter of core or working part at length l1; d2diameter of core or working part at length l2; d3diameter of core or working part at length l3; h height of barb; l1tip length, measured from tip point (for Type 1 and Type 2) to b

30、ase of first barb; l2length for measuring point d2; l3length for measuring point d3and minimum length of working part, distance from the tip of the instrument to the tip of the last barb; l4length of operative part. 4 Classification For the purposes of this document, root-canal instruments are class

31、ified according to the shape and intended endodontic application of the instrument as follows: Type 1: barbed broaches; Type 2: rasps; Type 3: paste carriers; Type 4: explorers and cotton broaches. BS EN ISO 3630-4:2009ISO 3630-4:2009(E) ISO 2009 All rights reserved 35 Requirements 5.1 Material The

32、material for the working part of the root-canal instrument and for the handle or shank is left to the discretion of the manufacturer. The handle and shank security shall meet the requirement specified in ISO 3630-1:2008, 5.7. 5.2 Dimensions 5.2.1 General The nominal diameters, selected by the manufa

33、cturer, represent the sizes of the instrument and shall meet the requirements included in Figures 1 to 4 and Tables 1 to 4. The length of the operative part of the root-canal instrument shall be the nominal length as specified by the manufacturer with a tolerance of 0,5 mm. 5.2.2 Barbed broaches (Ty

34、pe 1 instruments) Type 1 instruments shall meet the dimensions and tolerances specified in Figure 1 and Table 1. The shape of the tip and the design of the handle for hand use are at the discretion of the manufacturer. Key 1 handle Figure 1 Type 1 instruments (barbed broaches) BS EN ISO 3630-4:2009I

35、SO 3630-4:2009(E) 4 ISO 2009 All rights reservedTable 1 Dimensions and designations for Type 1 instruments (barbed broaches) Dimensions in millimetres Designation by Nominal size d1Toleranced2Toleranced3Tolerancel2l3 1,5l4min.h Number of barbs min. colour number of rings020 0,12 0,15 0,22 0,075 purp

36、le 0 025 0,14 0,17 0,24 0,085 white 1 030 0,16 0,02 0,19 0,02 0,26 0,02 0,096 yellow 2 035 0,18 0,21 0,28 0,105 red 3 040 0,21 0,03 0,24 0,03 0,31 0,03 0,120 blue 4 050 0,25 0,28 0,35 0,140 green 5 060 0,29 0,04 0,32 0,04 0,39 0,04 3 10,5 20 0,160 36 black 6 5.2.3 Rasps (Type 2 instruments) Type 2 i

37、nstruments shall meet the dimensions and tolerances specified in Figure 2 and Table 2. The shape of the tip and the design of the handle are at the discretion of the manufacturer. Key 1 handle Figure 2 Type 2 instruments (rasps) BS EN ISO 3630-4:2009ISO 3630-4:2009(E) ISO 2009 All rights reserved 5T

38、able 2 Dimensions and designations for Type 2 instruments (rasps) Dimensions in millimetres Designation by Nominal size ad1+0,03 0 d2+0,03 0 d3+0,03 0 l2l3 1,5 l4min. h Number of barbs min. colour number of rings 025 0,15 0,20 0,31 0,05 white 1 030 0,18 0,23 0,34 0,06 yellow 2 035 0,21 0,26 0,37 0,0

39、7 red 3 040 0,24 0,29 0,40 0,08 blue 4 045 0,27 0,32 0,43 0,09 green 5 050 0,30 0,35 0,46 3 10,5 20 0,10 50 black 6 aNominal size = h 2 + d1because of 50 barbs. 5.2.4 Paste carriers (Type 3 instruments) Type 3 instruments shall meet the dimensions and tolerances specified in Figure 3 and Table 3. Th

40、e taper of the working part shall be from 0 % to 2 %. Shanks shall be of Types 1 and 2 of ISO 1797-1 and ISO 1797-2. The winding of the spiral shall be such as to convey the material to the tip of the instrument when rotated clockwise as viewed from the handle or shank end. Figure 3 Type 3 instrumen

41、ts (paste carriers) Table 3 Dimensions and designations for Type 3 instruments (paste carriers) Dimensions in millimetres Designation by Nominal size d1 0,02 l2l3min. colour number of rings 025 0,25 red 1 030 0,30 blue 2 035 0,35 green 3 040 0,40 3 16 black 4 BS EN ISO 3630-4:2009ISO 3630-4:2009(E)

42、6 ISO 2009 All rights reserved5.2.5 Explorers and cotton broaches (Type 4 instruments) Type 4 instruments shall meet the dimensions and tolerances specified in Figure 4 and Table 4. The taper along the operative part shall be 0,007:1, with a tolerance of +0,003. The cross-section along the operative

43、 part (e.g. round or polygonal) shall be at the discretion of the manufacturer. Figure 4 Type 4 instruments (explorers and cotton broaches) Table 4 Dimensions and designations for Type 4 instruments (explorers and cotton broaches) Dimensions in millimetres Designation by Nominal size d1 0,02 d2 0,02

44、 d3max. l1l2l3l4 1,5 colour number of rings 012 0,12 0,20 purple 1 015 0,14 0,23 white 2 017 0,16 0,25 yellow 3 020 0,18 0,28 blue 4 025 0,21 0,33 green 5 030 0,25 0,38 0,8 2 d110,5 25 50 black 6 5.3 Colour designation and size marking with rings If the manufacturer uses colours and/or rings to iden

45、tify the size of the instrument, such marking(s) shall comply with the requirements of Tables 1 to 4. BS EN ISO 3630-4:2009ISO 3630-4:2009(E) ISO 2009 All rights reserved 75.4 Mechanical requirements 5.4.1 Resistance to fracture by twisting (torque) and angular deflection When barbed broaches and ra

46、sps are tested in accordance with ISO 3630-1:2008, 7.4, the instrument shall not fracture at less than the minimum value for the resistance to fracture by twisting (torque) and angular deflection, as specified in Table 5 and Table 6. Table 5 Resistance to fracture by twisting (torque) Resistance to

47、fracture by twisting (torque) mNm min. Nominal size Type 1 (barbed broaches) Type 2 (rasps) Type 4 (explorers and cotton broaches)020 0,5 n/a a1,2 025 0,6 0,8 2,1 030 0,8 1,0 3,5 035 1,0 1,2 n/a 040 1,2 2,0 n/a 045 n/a 2,6 n/a 050 2,0 3,4 n/a 060 3,4 n/a n/a an/a = Not applicable; these instrument s

48、izes are not manufactured. Table 6 Resistance to fracture by angular deflection Nominal size Type 1 (barbed broaches) Type 2 (rasps) Type 4 (explorers and cotton broaches) Angular deflection min. 020 020 012 025 025 015 030 030 017 035 035 020 040 040 025 045 045 030 050 050 n/a a060 060 n/a 90 an/a

49、 = Not applicable; these instrument sizes are not manufactured. BS EN ISO 3630-4:2009ISO 3630-4:2009(E) 8 ISO 2009 All rights reserved5.4.2 Stiffness (resistance to bending) When barbed broaches and rasps are tested in accordance with ISO 3630-1:2008, 7.5, the instrument shall not fracture and the maximum value given in Table 7 shall not be exceeded. Table 7 Stiffness (resistance to bending) Bending moment mNm max. Nominal size Type 1 (barbed broach