DIN EN ISO 3630-4-2009 Dentistry - Root canal instruments - Part 4 Auxiliary instruments (ISO 3630-4 2009) English version of DIN EN ISO 3630-4 2009-10《牙科 根管器械 第4部分 辅助器械(ISO 3630-4.pdf

1、October 2009DEUTSCHE NORM English price group 10No 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 11.060.25!$Z)q“1550678

2、www.din.deDDIN EN ISO 3630-4Dentistry Root canal instruments Part 4: Auxiliary instruments (ISO 3630-4:2009)English version of DIN EN ISO 3630-4:2009-10Zahnheilkunde Wurzelkanalinstrumente Teil 4: Hilfsinstrumente (ISO 3630-4:2009)Englische Fassung DIN EN ISO 3630-4:2009-10www.beuth.deDocument compr

3、ises 16 pages2 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 Normenausschuss Dental (Dentistr

4、y Standards Committee), Technical Committee NA 014-00-04 AA Rotierende Instrumente. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1797-1 DIN EN ISO 1797-1 ISO 1797-2 DIN EN ISO 1797-2 ISO 1942 E DIN EN ISO 1942 ISO 3630-1 DIN EN ISO 3

5、630-1 ISO 3630-2 DIN EN ISO 3630-2 National Annex NA (informative) Bibliography DIN EN ISO 1797-1, Dental rotary instruments Shanks Part 1: Shanks made of metals DIN EN ISO 1797-2, Dental rotary instruments Shanks Part 2: Shanks made of plastics E DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 36

6、30-1, Dentistry Root-canal instruments Part 1: General requirements and test methods DIN EN ISO 3630-2, Dental root-canal instruments Part 2: Enlargers DIN EN ISO 3630-4:2009-10 EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 3630-4July 2009ICS 11.060.20English VersionDentistry - Root canal in

7、struments - Part 4: Auxiliary instruments(ISO 3630-4:2009)Art dentaire - Instruments pour canaux radiculaires - PartieInstruments auxiliaires (ISO 3630-4:2009)Zahnheilkunde - Wurzelkanalinstrumente - Teil 4:Hilfsinstrumente (ISO 3630-4:2009)This European Standard was approved by CEN on 20 June 2009.

8、CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on app

9、lication to the CEN Management 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre h

10、as the same status as theofficial versions.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, Port

11、ugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means rese

12、rvedworldwide for CEN national Members.Ref. No. EN ISO 3630-4:2009: E4:2 Contents Page Foreword .3 1 Scope4 2 Normative references4 3 Terms, definitions and symbols 4 3.1 Terms and definitions .4 3.2 Symbols5 4 Classification .5 5 Requirements.6 5.1 Material .6 5.2 Dimensions 6 5.3 Colour designatio

13、n and size marking with rings .9 5.4 Mechanical requirements .10 5.5 Resistance to corrosion12 5.6 Heat effects of sterilization.12 6 Sampling 12 7 Testing12 7.1 General .12 7.2 Dimensions 12 8 Designation, marking and identification.13 9 Packaging.13 10 Labelling.13 Bibliography14 DIN EN ISO 3630-4

14、2009-10 EN ISO 3630-4:2009 (E) 3 Foreword This document (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

15、 national standard, either by publication of an identical 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

16、 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 are bound to implement this European Standard: Austria, Belgium, Bulgaria

17、 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, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of

18、ISO 3630-4:2009 has been approved by CEN as a EN ISO 3630-4:2009 without any modification. DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 1 Scope This part of ISO 3630 specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures no

19、t cited in 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

20、references, 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 plastic

21、s ISO 1942, 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 an

22、d definitions 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 can

23、al by abrasive action 3.1.3 paste carrier root-canal instrument designed for conveying filling material or medicaments into a root canal DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 43.1.4 root-canal explorer root-canal instrument designed for exploring the root canal system 3.1.5 cotton broach

24、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 Symbols For th

25、e 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 base of firs

26、t 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 classified accor

27、ding 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. DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 55 Requirements 5.1 Material The material for the working part o

28、f 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 manufacturer, represent the sizes of

29、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 (Type 1 instruments) Type 1 instru

30、ments 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) DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 6Tab

31、le 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 purple 0 025 0,14 0,17 0,24 0,085 white 1 030 0,16 0,02

32、 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 instruments shall meet the dimensions and tolerances

33、 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) DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 7Table 2 Dimensions and designations for Type 2 instruments (rasps) Dimen

34、sions 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 0,07 red 3 040 0,24 0,29 0,40 0,08 blue 4 045 0,27 0,32 0,43 0,09 green 5

35、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. The taper of the working part shall be from 0 % to 2 %. Shanks shall be o

36、f 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 instruments (paste carriers) Table 3 Dimensions and designations for Type 3 inst

37、ruments (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 DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 85.2.5 Explorers and cotton broaches (Type 4 instruments) Type

38、 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 part (e.g. round or polygonal) shall be at the discretion of the manufacturer. Figure 4 Ty

39、pe 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 d3max. l1l2l3l4 1,5 colour number of rings 012 0,12 0,20 purple 1 015 0,14 0,23 white 2 01

40、7 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 identify the size of the instrument, such marking(s) shall comply with the requirements of Tabl

41、es 1 to 4. DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E) 95.4 Mechanical requirements 5.4.1 Resistance to fracture by twisting (torque) and angular deflection When barbed broaches and rasps are tested in accordance with ISO 3630-1:2008, 7.4, the instrument shall not fracture at less than the mini

42、mum 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 fracture by twisting (torque) mNm min. Nominal size Type 1 (barbed broaches) Type 2 (rasps) Type 4 (explorers a

43、nd 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 sizes are not manufactured. Table 6 Resistance to fracture by angular deflection Nominal size Type 1 (barbed bro

44、aches) 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 = Not applicable; these instrument sizes are not manufactured. DIN EN ISO 3630-4:2009-10 EN ISO 3630-4:2009 (E

45、) 105.4.2 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 siz

46、e Type 1 (barbed broaches) Type 2 (rasps) Type 4 (explorers and cotton broaches) 020 2,5 n/a an/a 025 2,9 4,9 7,8 030 3,9 6,9 11,7 035 4,9 8,8 16,6 040 7,8 13,7 n/a 045 n/a 16,7 n/a 050 11,8 20,6 n/a 060 16,7 n/a n/a an/a = Not applicable; these instrument sizes are not manufactured. 5.4.3 Handle an

47、d shank security The handle shall meet the requirements of ISO 3630-1:2008, 5.9.3. 5.4.4 Resistance to fatigue (only applicable for Type 3 instruments) The following requirement is only applicable for paste carriers: When paste carriers are tested in accordance with ISO 3630-2:2000, 6.5, all of the

48、tested instruments shall meet the minimum number of revolutions given in Table 8. Table 8 Resistance to fatigue for Type 3 instruments (paste carriers) Nominal size Diameter mm Number of revolutions min. 025 0,25 4 000 030 0,30 2 400 035 0,35 1 500 040 0,40 000 DIN EN ISO 3630-4:2009-10 EN ISO 3630-

49、4:2009 (E) 115.5 Resistance to corrosion The root-canal instrument shall meet the requirements of ISO 3630-1:2008, 5.10. 5.6 Heat effects of sterilization 5.6.1 General The root-canal instrument shall meet the requirements of ISO 3630-1:2008, 5.10.2. 5.6.2 Single-use instruments Following one cycle of sterilization by autoclave and dry heat, the instrument shall comply with the requirements specified in 5.4.1, 5.4.2, 5.4.3 and 5.4.4, when tested as specified in ISO 3630-1:2008, 7.8