1、January 2012 Translation by DIN-Sprachendienst.English price group 9No part of this translation 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
2、 11.060.25!$y,m“1860974www.din.deDDIN EN ISO 3630-5Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments (ISO 3630-5:2011)English translation of DIN EN ISO 3630-5:2012-01Zahnheilkunde Endodontische Instrumente Teil 5: Form- und Reinigungsinstrumente (ISO 3630-5:2011)Englische ber
3、setzung von DIN EN ISO 3630-5:2012-01Mdecine bucco-dentaire Instruments dendodontie Partie 5: Instruments de mise en forme et de nettoyage (ISO 3630-5:2011)Traduction anglaise de DIN EN ISO 3630-5:2012-01www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be cons
4、idered authoritative.1401.12 DIN EN ISO 3630-5:2012-01 2 A comma is used as the decimal marker. 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
5、 German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working 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 1942 DIN EN ISO 1942 ISO
6、3630-1 DIN EN ISO 3630-1 ISO 3630 consists of the following parts, under the general title Dentistry Endodontic instruments: Part 1: General requirements and test methods Part 2: Enlargers Part 3: Condensers, pluggers and spreaders Part 4: Auxiliary instruments Part 5: Shaping and cleaning instrumen
7、ts National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 3630-1, Dentistry Root-canal instruments Part 1: General requirements and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-5 October 2011 ICS 11.060.20 English Version Dentistry
8、 - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011) Mdecine bucco-dentaire - Instruments dendodontie - Partie 5: Instruments de mise en forme et de nettoyage (ISO 3630-5:2011) Zahnheilkunde - Endodontische Instrumente - Teil 5: Form-und Reinigungsinstrumente (ISO 3
9、630-5:2011) This European Standard was approved by CEN on 30 September 2011. 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 bibli
10、ographical 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 (English, French, German). A version in any other language made by translation under the respons
11、ibility 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gree
12、ce, 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 EUROPISCHES KOMITEE FR NORMUNG Manageme
13、nt Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3630-5:2011: EContents DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 2 Page Foreword 3 Introduction .4 1 Scope 5 2 Normative r
14、eferences 5 3 Terms and definitions .5 4 Classification 5 5 Requirements .5 5.1 Material .5 5.2 Dimensions .5 5.3 Mechanical 6 5.4 Chemical .9 5.5 Colour coding 10 6 Sampling 10 7 Testing . 10 7.1 General . 10 7.2 Fracture location . 10 8 Designation, marking, and identification . 10 9 Packaging 10
15、10 Instructions for use 11 11 Labelling 11 Bibliography . 12 Foreword This document (EN ISO 3630-5:2011) 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 shal
16、l be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by April 2012. Attention is drawn to the possibility that some of the elements of this document
17、 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 organizations of the following countries are bound to implement this European Standard: Aust
18、ria, Belgium, Bulgaria, Croatia, 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.
19、Endorsement notice The text of ISO 3630-5:2011 has been approved by CEN as a EN ISO 3630-5:2011 without any modification. “ DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 3 IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazards are not included in this p
20、art of ISO 3630. However, in assessing possible biological or toxicological hazards, it is recommended that reference be made to ISO 10993-1 and ISO 7405.Attention is drawn to ISO 6360 (all parts), which specifies a 15-digit number for the identification of dental rotary instruments of all types.DIN
21、 EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 4 1 ScopeThis part of ISO 3630 specifies requirements and test methods for hand-held or mechanically operated shaping and cleaning instruments used to perform root canal procedures not cited in ISO 3630-1, ISO 3630-2, ISO 3630-3 or ISO 3630-4.This part o
22、f ISO 3630 specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated
23、references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3630-1:2008, Dentistry Root-canal instruments Part 1: General requirements and test methods3 Terms and definitionsFor the purposes of this document, the terms and definition
24、s given in ISO 1942 and ISO 3630-1 apply.4 ClassificationFor the purposes of this document, shaping and cleaning instruments are classified into five types, as specified in ISO 3630-1:2008, Clause 4.5 Requirements5.1 MaterialThe materials used for the working part, the shank and the handle of shapin
25、g and cleaning instruments are left to the discretion of the manufacturer but shall meet the requirements of ISO 3630-1:2008, 5.7.5.2 Dimensions5.2.1 GeneralThe dimensions for the nominal diameter and taper of shaping and cleaning instruments shall meet the requirements of ISO 3630-1:2008, Clause 5.
26、The allowable tolerance for the identified diameters of Types 2, 3, 4, and 5 shall be less than 50 % of the difference between the preceding size and the next larger size instrument of the available brand sizes.DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 5 5.2.2 DiameterThe diameter of the shap
27、ing and cleaning instrument shall be as specified in ISO 3630-1.5.2.3 LengthThe length of the shaping and cleaning instrument shall be as specified in ISO 3630-1 and shall be measured as specified in ISO 3630-1:2008, 7.3.5.2.4 For Type 1Working part length shall be at least 16 mm. Operative part len
28、gth and overall length shall be left to the discretion of the manufacturer. The manufacturer shall specify operative end length, which shall be within 0,5 mm of the length specified. When provided by the manufacturer, the actual overall length shall be within 1,0 mm of the stated length.5.2.5 For Ty
29、pes 2, 3, 4 and 5Working part length, operative part length, and overall length shall be left to the discretion of the manufacturer. The manufacturer shall specify working part length as a minimum; operative part length shall be within 0,5 mm of the length specified. When provided by the manufacture
30、r, the actual overall length shall be within 1,0 mm of the stated length.5.3 Mechanical5.3.1 Resistance to fracture by twisting and angular deflectionWhen tested in accordance with ISO 3630-1:2008, 7.4, the shaping and cleaning instrument shall not fracture at less than the minimum value specified f
31、or the resistance to fracture in twisting and angular deflection, given as follows:a) for Type 1, standard instruments, in Table 1;b) for Type 2, tapered instruments, in Table 2 and Table 3;c) for Type 3, shaped instruments, in Table 1;d) for Type 4, non-tapered instruments, in Table 1; e) for Type
32、5, non-uniform tapered instruments, in Table 2 and Table 3.5.3.2 StiffnessThe stiffness is tested as resistance to bending.When tested as specified in ISO 3630-1:2008, 7.5, the shaping and cleaning instrument shall not fracture and the maximum value given shall not be exceeded, as follows:a) for Typ
33、e 1, standard instruments, in Table 4;b) for Type 2, tapered instruments, in Table 5;c) for Type 3, shaped instruments, in Table 6;d) for Type 4, non-tapered instruments, in Table 4; e) for Type 5, non-uniform tapered instruments, in Table 5.DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 6 Table 1
34、 Resistance to fracture by twisting and angular deflection (applicable to Type 1, Type 3 and Type 4 instruments)Nominal size Resistance to fracture (torque) Angular deflectionmm mNm, min. Degrees (), min.Instrument K File H File K ReamerK File and K ReamerH File06 0,34 0,34 0,34 360 18008 0,50 0,50
35、0,50 360 18010 0,60 0,60 0,60 360 18015 0,80 0,80 0,80 360 18020 1,76 1,18 1,18 360 18025 2,94 1,96 1,96 360 18030 4,42 3,43 3,43 360 18035 6,36 4,91 4,91 360 18040 9,81 6,37 6,87 360 12045 11,78 8,82 9,32 360 12050 16,68 11,78 11,78 360 120Table 2 Resistance to fracture by twisting (applicable to T
36、ype 2 and Type 5 instruments)Diameter of instrument at test locationResistance to fracture (torque)mm mNm, min.Instrument K File H File K Reamer 0,124 0,34 n/aa0,340,124 to 0,164 0,59 0,49 0,590,164 to 0,214 0,79 0,79 0,790,214 to 0,264 1,77 1,18 1,180,264 to 0,314 2,94 1,96 1,960,314 to 0,364 4,42
37、3,43 3,430,364 to 0,414 6,38 4,91 4,910,414 to 0,464 9,81 6,38 6,870,464 to 0,514 11,78 8,83 9,320,514 to 0,564 16,68 11,78 11,78an/a = not applicable.DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 7 Table 3 Angular deflection (applicable to Type 2 and Type 5 instruments)Diameter of instrument at
38、test location (d2)Angular deflectionmm Degrees (), min.Instrument K File H File K Reamer 0,414 360 180 3600,414 to 0,564 360 120 3600,564 to 0,764 360 90 360Table 4 Bending moments (applicable to Type 1 and Type 4 instruments)Nominal size Bending momentmm mNm, max.Instrument K File H File K Reamer06
39、 1,47 n/aa1,4708 1,96 1,96 1,9610 2,45 1,96 2,4515 4,91 3,43 4,9120 7,85 6,37 7,8525 11,78 9,80 11,7830 14,72 13,23 14,7235 18,65 16,66 21,5940 24,53 21,59 31,4045 35,33 31,36 36,8050 44,16 50,96 40,24an/a = not applicable.DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 8 Table 5 Bending moments (a
40、pplicable to Type 2 and Type 5 instruments)Diameter of instrument at test location (d2)Bending momentmm mNm, max.Instrument K File H File K Reamer 0,124 1,47 n/aa1,470,124 to 0,164 2,45 1,96 2,450,164 to 0,214 4,91 3,43 4,910,214 to 0,264 7,85 6,38 7,850,264 to 0,314 11,78 9,81 11,780,314 to 0,364 1
41、4,72 13,25 14,720,364 to 0,414 18,65 16,68 21,590,414 to 0,464 24,53 21,59 31,400,464 to 0,514 35,33 31,40 36,800,514 to 0,564 44,16 51,03 40,24an/a = not applicable.Table 6 Bending moments (applicable to Type 3 instruments)Nominal sizemmBending momentmNm, max.20 6,5525 8,1930 8,7335 10,9140 12,0045
42、 13,1050 14,755.3.3 Position of fracture point (Type 3 only)Fracture location of the “shaped” instrument when tested for the requirements given in 5.3.1 and 5.3.2 shall be 4 mm or less from the junction of the handle or shank with the instrument, when tested as specified in 7.2.5.3.4 Handle or plast
43、ics shank securityThe handle or plastics shank shall meet the requirements given in ISO 3630-1:2008, 5.8.3.5.4 Chemical5.4.1 Resistance to corrosionThe shaping and cleaning instrument shall meet the requirements given in ISO 3630-1:2008, 5.10.1.DIN EN ISO 3630-5:2012-01 EN ISO 3630-5:2011 (E) 9 5.4.
44、2 Heat effects of sterilizationThe shaping and cleaning instrument shall meet the requirements given in ISO 3630-1:2008, 5.10.2.After performing the test as specified in ISO 3630-1:2008, 7.8, the shaping and cleaning instrument shall meet the requirements given in 5.3.Shaping and cleaning instrument
45、s identified as “For single use”, and which are delivered in a sterile state, are excluded from the requirements of ISO 3630-1:2008, 5.7.5.5 Colour codingWhen colour coding is included for size or taper, the colour shall comply with the requirements specified in ISO 3630-1:2008, 5.2.3, 5.3.6, 5.3.7,
46、 5.4.3, 5.5.3, 5.6.6 and 5.6.7.6 SamplingFor each test, unless otherwise specified, at least 95 % of the samples tested shall comply. The sampling plan is as follows. Test ten shaping and cleaning instruments of each size. If all ten samples pass, the product passes. If eight or fewer samples pass,
47、the product fails. If nine samples pass, test ten additional samples. When ten additional samples are to be tested, all additional ten samples shall pass for the product to be accepted.7 Testing7.1 GeneralTest methods are specified in ISO 3630-1:2008, Clause 7, except those given in 7.2.7.2 Fracture
48、 location7.2.1 ApparatusUse apparatus as described in ISO 3630-1:2008, 7.3.2.7.2.2 ProcedureAfter each test described in 5.3.1 and 5.3.2, measure the length of the remaining neck from the end of the handle or shank to the fracture point.Record the measurements.8 Designation, marking, and identificationThe nominal sizes of shaping and cleaning instruments shall be marked on the handle or shank. Identification symbols shall comply with the requirements specified in ISO 3630-1:2008, Clause 8.9 PackagingPacka
