DIN EN ISO 3630-1-2008 Dentistry - Root-canal instruments - Part 1 General requirements and test methods (ISO 3630-1 2008) English version of DIN EN ISO 3630-1 2008-04《牙科 牙根管器械 第1部.pdf

1、April 2008DEUTSCHE NORM English price group 13No 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!$NU“1435059www

2、din.deDDIN EN ISO 3630-1Dentistry Root-canal instruments Part 1: General requirements and test methods (ISO 3630-1:2008)English version of DIN EN ISO 3630-1:2008-04Zahnheilkunde Wurzelkanalinstrumente Teil 1: Allgemeine Anforderungen und Prfverfahren (ISO 3630-1:2008)Englische Fassung DIN EN ISO 36

3、30-1:2008-04SupersedesDIN EN ISO 3630-1:1994-12www.beuth.deDocument comprises 26 pagesDIN EN ISO 3630-1:2008-04 2 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

4、). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-04 AA Rotierende Instrumente. ISO 3630 consists of the following parts, under the general title Dentistry Root-canal instruments: Part 1: General r

5、equirements 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 The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN a

6、re as follows: ISO 554 DIN 50014 ISO 1797-1 DIN EN ISO 1797-1 ISO 1797-2 DIN EN ISO 1797-2 ISO 1942 E DIN EN ISO 1942 ISO 3630-2 DIN EN ISO 3630-2 ISO 3696 DIN ISO 3696 ISO 6360-1 DIN EN ISO 6360-1 ISO 6360-2 DIN EN ISO 6360-2 ISO 8601 DIN ISO 8601 ISO 13402 DIN EN ISO 13402 ISO 15223-1 DIN EN 980 A

7、mendments This standard differs from DIN EN ISO 3630-1:1994-12 as follows: a) The standard specifies general requirements. b) The requirements for the dimensions (sizes) of specific instruments are now dealt with in the new Parts 4 and 5. c) The requirements for labelling have been specified in more

8、 detail. Previous editions DIN 13960: 1969-01, 1976-09, 1985-09 DIN 13961: 1969-01, 1976-09, 1988-03 DIN 13962: 1969-01, 1976-09 DIN EN ISO 3630-1:2008-04 3 DIN 13963: 1969-01, 1988-03 DIN 13964: 1988-03 DIN 13966: 1988-03 DIN 13967-2: 1985-02 DIN 13967-3: 1985-04 DIN EN ISO 3630-1: 1994-12 National

9、 Annex NA (informative) Bibliography DIN EN 980, Symbols for use in the labelling of medical devices 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 Term

10、inology DIN EN ISO 3630-2, Dental root-canal instruments Part 2: Enlargers DIN EN ISO 6360-1, Dentistry Number coding system for rotary instruments Part 1: General characteristics DIN EN ISO 6360-2, Dentistry Number coding system for rotary instruments Part 2: Shapes DIN EN ISO 13402, Surgical and d

11、ental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN 50

12、014, Atmospheres and their technical application Standard atmospheres DIN EN ISO 3630-1:2008-04 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-1 February 2008 ICS 11.060.20 Supersedes EN ISO 3630-1:1994 English Version Dentistry - Root-canal instrume

13、nts - Part 1: General requirements and test methods (ISO 3630-1:2008) Art dentaire - Instruments pour canaux radiculaires - Partie 1: Exigences gnrales et mthodes dessai (ISO 3630-1:2008) Zahnheilkunde - Wurzelkanalinstrumente - Teil 1: Allgemeine Anforderungen und Prfverfahren (ISO 3630-1:2008) Thi

14、s European Standard was approved by CEN on 7 January 2008. CEN members are bound to comply with 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 referen

15、ces concerning such national standards 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, German). A version in any other language made by translation under the responsibility of a CEN member in

16、to its own language and notified to the CEN Management Centre has the same status as the official 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

17、 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brusse

18、ls 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3630-1:2008: EContents Page 2 DIN EN ISO 3630-1:2008-04 EN ISO 3630-1:2008 (E) -1 - :4 Classification 7 5 Requirements 7 5.1 General .7 5.2 Type 1: standard-sized instrume

19、nts .7 5.3 Type 2: taper-sized instruments .9 5.4 Type 3: shape-sized instruments 10 5.5 Type 4: non-taper-sized instruments 11 5.6 Type 5: non-uniform taper-sized instruments .12 5.7 Material 13 5.8 Dimensions 13 5.9 Mechanical requirements .13 5.10 Chemical requirements 14 6 Sampling 14 7 Testing

20、14 7.1 Visual inspection 14 7.2 Test conditions .14 7.3 Measurement of dimensions .15 7.4 Resistance to fracture by twisting and angular deflection 15 7.5 Stiffness .17 7.6 Handle and shank security 18 7.7 Corrosion test .18 7.8 Heat effects of sterilization 19 8 Designation, marking and identifica

21、tion 20 8.1 General .20 8.2 Identification symbols 20 9 Packaging 20 11 Labelling 21 Bibliography .22 Foreword 3 Introduction 4 1 Scope .5 2 Normative references .5 3 Terms, definitions and symbols 5 3.2 Symbols .7 3.1 Terms and definitions 5 10 Manufacturers instructions for use .20 3 DIN EN ISO 36

22、30-1:2008-04 EN ISO 3630-1:2008 (E) Foreword This document (EN ISO 3630-1:2008) 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 o

23、f a national standard, either by publication of an identical text or by endorsement, at the latest by August 2008, and conflicting national standards shall be withdrawn at the latest by August 2008. Attention is drawn to the possibility that some of the elements of this document may be the subject o

24、f patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 3630-1:1994. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this

25、 European Standard: Austria, Belgium, Bulgaria, 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 U

26、nited Kingdom. Endorsement notice The text of ISO 3630-1:2008 has been approved by CEN as a EN ISO 3630-1:2008 without any modification. Introduction The reorganization of ISO 3630 is intended to present the requirements and test methods for root-canal instruments in an orderly manner. This part of

27、ISO 3630 defines general requirements and test methods. Subsequent parts provide the specific requirements and test methods, if applicable, for two areas of endodontic procedures. These parts are enlargers, condensers and auxiliary instruments. With current use of nickel-titanium (Ni-Ti) alloys for

28、manufacture of root canal instruments a need for adequate expertise in their safe use is recommended. Instruments made of Ni-Ti can be easily broken near the tip if manufacturers cautions are not understood and practiced. This part of ISO 3630 does not attempt to provide information for proper use o

29、f any instruments. The sizes of the root-canal obturating points (cones) specified in ISO 68774have to be aligned with the corresponding sizes for root-canal instruments specified in ISO 3630. 4 DIN EN ISO 3630-1:2008-04 EN ISO 3630-1:2008 (E) 1 Scope This part of ISO 3630 specifies general requirem

30、ents and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments. In addition it covers general size designations, colour coding, packaging and identification symbols. 2 Normative references The fol

31、lowing referenced documents are indispensable for the application 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 554, Standard atmospheres for conditioning and/or te

32、sting Specifications ISO 1942, Dental vocabulary (all parts) ISO 1797-1:1992, Dental rotary instruments Shanks Part 1: Shanks made of metals ISO 1797-2:1992, Dental rotary instruments Shanks Part 2: Shanks made of plastics ISO 3630-2:2000, Dental root-canal instruments Part 2: Enlargers ISO 3696:198

33、7, Water for analytical laboratory use Specification and test methods ISO 6360-2, Dentistry Number coding system for rotary instruments Part 2: Shapes ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 13402, Surgical and dental hand instrum

34、ents Determination of resistance against autoclaving, corrosion and thermal exposure ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 3 Terms, definitions and symbols 3.1 Terms and definitions For the pu

35、rposes of this document, the terms and definitions given in ISO 1942 and the following apply. 5 EN ISO 3630-1:2008 (E) DIN EN ISO 3630-1:2008-04 3.1.1 root-canal instrument endodontic instrument dental instrument designed to explore, shape, clean and fill root canal systems 3.1.2 standard-sized inst

36、rument root-canal instrument throughout the range of sizes available having a uniform taper of 0,02 mm per millimetre of length NOTE The nominal size of the root-canal instrument is listed in Table 1. 3.1.3 non standard-sized instrument root-canal instrument which has other tip sizes than the standa

37、rd-sized instrument NOTE The nominal size of the root-canal instrument is not listed in Table 1. 3.1.4 taper-sized instrument root-canal instrument the sizes of which are determined by the tip sizes that have tapers other than 0,02 mm per millimetre of length 3.1.5 shape-sized instrument root-canal

38、instrument having a contoured working part with continuously varying profile 3.1.6 non taper-sized instrument root-canal instrument having a cylindrical form along the long axis 3.1.7 non-uniform taper-sized instrument root-canal instrument having more than one taper along the working part 3.1.8 fle

39、xible instrument root-canal instrument whose average test value when tested according to 7.5, shall be 65 %, or less, of the value listed in the appropriate bending or stiffness table of referenced specifications 3.1.9 guided tip instrument root-canal instrument having a tip which guides access with

40、in root canal systems 3.1.10 tip portion of the instrument that part of the root-canal instrument which is intended as the point, the shape of which is at the discretion of the manufacturer 3.1.11 working part portion of the root-canal instrument with an active cutting surface 3.1.12 shank part of t

41、he root-canal instrument to be connected to a handpiece 3.1.13 handle part of the root-canal instrument to be manipulated by the user by hand 6 DIN EN ISO 3630-1:2008-04 EN ISO 3630-1:2008 (E) 3.1.14 operative part portion of the root-canal instrument from the tip to the handle or shank 3.2 Symbols

42、For the purposes of this document, the following symbols apply. d1diameter of the projection of the working part at the tip end (reference size); d2diameter at length l2; d3diameter at the end of minimum length of working part, length l3; l1tip length; l2length for measuring point d2; l3length for m

43、easuring point d3and minimum length of working part; l4length of operative part. 4 Classification For the purposes of this document, root-canal instruments are classified according to the shape and taper of the tip size (see Figure 1) as follows. Type 1: standard-sized instruments (taper = 2 %); Typ

44、e 2: taper-sized instruments (taper other than 2 %); Type 3: shape-sized instruments (arc shape); Type 4: non-taper-sized instruments (zero taper); Type 5: non-uniform taper-sized instruments (more than one taper). 5 Requirements 5.1 General Specific root-canal instrument types, such as enlargers, h

45、ave unique shapes which are not included here. These cases are covered in ISO 3630-2 and ISO 3630-3. 5.2 Type 1: standard-sized instruments 5.2.1 Length The length of the working part, l3, shall be a minimum of 16 mm unless otherwise specified by the manufacturer. The lengths of the working part, wh

46、en specified, and of the operative part, l4, shall be within 0,5 mm of the specified lengths. Test in accordance with 7.3. 7 EN ISO 3630-1:2008 (E) DIN EN ISO 3630-1:2008-04 Figure 1 Dimensions and locations for Type 1 (standard-sized instruments; taper = 2 %) 5.2.2 Size designation and diameters Ta

47、ble 1 gives the nominal sizes and dimensions for the working part to be used for Type 1 (standard-sized instruments). Tip sizes (d1) other than those listed in Table 1 are permitted. Figure 1 shows the position of the diameters and lengths for all Type 1 root-canal instruments. The nominal sizes sha

48、ll correspond to the values of the extended diameters at the tip of the working part in hundredths of a millimetre. NOTE The designation (code number) with three digits is part of the 15-digit identification number specified in ISO 6360-1 and ISO 6360-2. 5.2.3 Colour designation Table 1 gives the co

49、lour designation for each size of Type 1 instrument. These colours are used on the handle or shank and specify the size identification of the working part. Colours of sizes not included in Table 1 are at the discretion of the manufacturer. 5.2.4 Tip shape The shape of the tip is at the discretion of the manufacturer. 5.2.5 Tip length and angle The tip length shall be within the limits specified by the minimum and maximum angle (l1min. to l1max.) as shown in Figure 1.