EN ISO 3630-5-2011 en Dentistry - Endodontic instruments - Part 5 Shaping and cleaning instruments《牙科业 牙髓器械 第5部分 塑性和清洁工具(ISO 3630-5-2011)》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 3630-5:2011Dentistry EndodonticinstrumentsPart 5: Shaping and cleaning instruments(ISO 3630-5:2011)BS EN ISO 3630-5:2011 BRITISH STANDARDNational forewordThis British S

2、tandard is the UK implementation of EN ISO3630-5:2011.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purp

3、ort to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 65530 2ICS 11.060.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandar

4、ds Policy and Strategy Committee on 31 October 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3630-5 October 2011 ICS 11.060.20 English Version Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-

5、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 3630-5:2011) This European Standard was approved by CEN on 30 September 2011. CE

6、N 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 references concerning such national standards may be obtained on app

7、lication 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 responsibility of a CEN member into its own language and notified to the CEN-CENELEC M

8、anagement 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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Net

9、herlands, 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: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitatio

10、n in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3630-5:2011: EBS EN ISO 3630-5:2011EN ISO 3630-5:2011 (E) 3 Foreword This document (EN ISO 3630-5:2011) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committe

11、e 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 identical text or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by

12、April 2012. 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

13、organizations 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

14、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 3630-5:2011 has been approved by CEN as a EN ISO 3630-5:2011 without any modification. BS EN ISO 3630-5:2011ForewordISO (the International Organization for Standardization)

15、is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally 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 repres

16、ented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are d

17、rafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International S

18、tandard requires 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 3630-5 was prepared

19、 by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.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:

20、 Auxiliary instruments Part 5: Shaping and cleaning instrumentsISO 3630-5:2011(E) ISO 2011 All rights reserved iiiBS EN ISO 3630-5:2011IntroductionSpecific qualitative and quantitative requirements for freedom from biological hazards are not included in this part of ISO 3630. However, in assessing p

21、ossible 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.ISO 3630-5:2011(E)iv ISO 2011 All rights re

22、servedBS EN ISO 3630-5:2011INTERNATIONAL STANDARD ISO 3630-5:2011(E)Dentistry Endodontic instruments Part 5:Shaping and cleaning instruments1 ScopeThis part of ISO 3630 specifies requirements and test methods for hand-held or mechanically operated shaping and cleaning instruments used to perform roo

23、t canal procedures not cited in ISO 3630-1, ISO 3630-2, ISO 3630-3 or ISO 3630-4.This part of ISO 3630 specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.2 Normative referencesThe following referenced documents are indispensable for the appl

24、ication 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 1942, Dentistry VocabularyISO 3630-1:2008, Dentistry Root-canal instruments Part 1: General requirements and te

25、st methods3 Terms and definitionsFor the purposes of this document, the terms and definitions 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 Require

26、ments5.1 MaterialThe materials used for the working part, the shank and the handle of shaping 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 o

27、f shaping and cleaning instruments shall meet the requirements of ISO 3630-1:2008, Clause 5.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 siz

28、es. ISO 2011 All rights reserved 1BS EN ISO 3630-5:20115.2.2 DiameterThe diameter of the shaping 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 363

29、0-1:2008, 7.3.5.2.4 For Type 1Working part length shall be at least 16 mm. Operative part length 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 man

30、ufacturer, the actual overall length shall be within 1,0 mm of the stated length.5.2.5 For Types 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

31、 part length 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.5.3 Mechanical5.3.1 Resistance to fracture by twisting and angular deflectionWhen tested in accordance with ISO 3630-1:2008, 7.4, the

32、shaping and cleaning instrument shall not fracture at less than the minimum value specified for 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, sh

33、aped instruments, in Table 1;d) for Type 4, non-tapered instruments, in Table 1; e) for Type 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 instrumen

34、t shall not fracture and the maximum value given shall not be exceeded, as follows:a) for Type 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-unifo

35、rm tapered instruments, in Table 5.ISO 3630-5:2011(E)2 ISO 2011 All rights reservedBS EN ISO 3630-5:2011Table 1 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. D

36、egrees (), 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 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

37、 11,78 8,82 9,32 360 12050 16,68 11,78 11,78 360 120Table 2 Resistance to fracture by twisting (applicable to Type 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

38、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 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.ISO 3630-5:2011(E) ISO 2011 All rights

39、 reserved 3BS EN ISO 3630-5:2011Table 3 Angular deflection (applicable to Type 2 and Type 5 instruments)Diameter of instrument at 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 Bendi

40、ng moments (applicable to Type 1 and Type 4 instruments)Nominal size Bending momentmm mNm, max.Instrument K File H File K Reamer06 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

41、31,36 36,8050 44,16 50,96 40,24an/a = not applicable.ISO 3630-5:2011(E)4 ISO 2011 All rights reservedBS EN ISO 3630-5:2011Table 5 Bending moments (applicable 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

42、 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 14,72 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 = n

43、ot 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 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

44、 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 plastics 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

45、shaping and cleaning instrument shall meet the requirements given in ISO 3630-1:2008, 5.10.1.ISO 3630-5:2011(E) ISO 2011 All rights reserved 5BS EN ISO 3630-5:20115.4.2 Heat effects of sterilizationThe shaping and cleaning instrument shall meet the requirements given in ISO 3630-1:2008, 5.10.2.After

46、 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 instruments identified as “For single use”, and which are delivered in a sterile state, are excluded from the requirements of ISO 3630-1:2008,

47、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, 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.

48、 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, the product fails. If nine samples pass, test ten additional samples. When ten additional samples are to be tested, all additional te

49、n 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 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 inst