DIN EN ISO 21606-2007 Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606 2007) English version of DIN EN ISO 21606 2007-10《牙科 正畸学用弹性体辅助装置》.pdf

1、October 2007DEUTSCHE NORM English price group 9No 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 11.060.10!$IO“1389044ww

2、w.din.deDDIN EN ISO 21606Dentistry Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007)English version of DIN EN ISO 21606:2007-10Zahnheilkunde Elastomere Elemente fr die Kieferorthopdie (ISO 21606:2007)Englische Fassung DIN EN ISO 21606:2007-10SupersedesDIN 13901:2001-12www.beuth.deDocu

3、ment comprises 14 pages DIN EN ISO 21606:2007-10 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). The responsible German body involved in its preparation was

4、the Normenausschuss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-18 Kieferorthopdische Produkte. The DIN Standards corresponding to the International Standards referred to in clause 2 and in the Bibliogra-phy of the EN are as follows: ISO 1942 E DIN EN ISO 1942 ISO 3696 DIN

5、ISO 3696 ISO 8601 DIN ISO 8601 Amendments This standard differs from DIN 13901:2001-12 as follows: a) Tests have been harmonized with international requirements. b) Marking has been updated (indication of the expiry date instead of the date of manufacturing). Previous editions DIN 13901: 2001-12 Nat

6、ional Annex NA (informative) Bibliography E DIN EN ISO 1942, Dentistry Terminology (draft stage) 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 EUROPEAN STA

7、NDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21606 June 2007 ICS 11.060.10 English Version Dentistry - Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007) Art dentaire - Auxiliaires lastomres utiliss en orthodontie (ISO 21606:2007) Zahnheilkunde - Elastomere Elemente fr die Kieferorthop

8、die (ISO 21606:2007) This European Standard was approved by CEN on 31 May 2007. 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 bi

9、bliographical references 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 responsibili

10、ty of a CEN member into 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, I

11、reland, 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 Management Centre: rue de Stass

12、art, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21606:2007: EContents Page 2 EN ISO 21606:2007 (E) Foreword 3 Introduction . 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Requir

13、ements . 7 4.1 General 7 4.2 Dimensions . 7 4.3 Mechanical properties . 7 5 Sampling . 8 6 Test methods 8 6.1 Ambient conditions . 8 6.2 Dimensions . 8 6.3 Initial extension force, F0. 8 6.4 24 hour residual force, F24 9 6.5 Ultimate extension, A 11 7 Marking, labelling and packaging . 11 7.1 Genera

14、l requirements . 11 7.2 Packaging and labelling . 11 Bibliography . 12 3Foreword This document (EN ISO 21606:2007) 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 S

15、tandard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2007, and conflicting national standards shall be withdrawn at the latest by December 2007. According to the CEN/CENELEC Internal Regulations, the nationa

16、l standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol

17、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 21606:2007 has been approved by CEN as EN ISO 21606:2007 without any modifications. EN ISO 21606:2007 (E) Introduction This first edition of ISO 21606 has been developed as a

18、 result of the difficulty often encountered by clinicians in making meaningful comparisons between elastomeric auxillaries using the information currently available from manufacturers and suppliers. Specific qualitative and quantitative requirements for freedom from biological hazards are not includ

19、ed in this International Standard, but it is recommended that in assessing possible biological hazards reference should be made to ISO 10993-1 and ISO 7405. 4 EN ISO 21606:2007 (E) 1 Scope This International Standard is applicable to all elastomeric auxiliaries including orthodontic elastics, elasto

20、meric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only t

21、he edition cited applies. For undated references, the latest edition of the referenced document, including any amendments, applies. ISO 19421), Dentistry Vocabulary ISO 3696:1987, Water for analytical use Specification and test methods ISO 8601, Data elements and interchange formats Information inte

22、rchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms and definitions of ISO 1942 and the following apply. 3.1 orthodontic elastics intra-oral and extra-oral elastomeric rings used to apply forces to teeth 3.2 orthodontic thread elastomeric th

23、read (may be hollow) of constant cross-section used to apply forces to teeth 3.3 orthodontic elastomeric chain interconnected elastomeric rings or a multi-perforated elastomeric band used to apply forces to teeth 3.4 orthodontic elastomeric ligatures elastomeric rings used to retain wires to orthodo

24、ntic attachments 3.5 orthodontic elastomeric separators elastomeric products used to open interproximal spaces between teeth 1) To be published. (Replaces ISO 1942, parts 1 to 5) 5 EN ISO 21606:2007 (E) 3.6 link length L distance between the centres of the holes of adjacent links of orthodontic elas

25、tomeric chains See Figure 1. 3.7 test length length of elastomeric units for units under five links; five links for chains; 20 mm loop circumference for thread; diameter of elastomeric ring without load See Figure 1. 3.8 initial extension force F0force exerted by the elastomeric auxiliary at three t

26、imes the test length after initial extension to four times the test length 3.9 24 hour residual force F24force exerted by the elastomeric auxiliary at three times the test length at 24 h, after initial extension to four times the test length, and expressed as a percentage of the initial extension fo

27、rce 3.10 ultimate extension A extension at break expressed as percentage of the test length Key 1 link length, L 2 test length 3 inner diameter, Di4 outer diameter, DoFigure 1 Test dimensions of elastomeric auxiliaries 6 EN ISO 21606:2007 (E) 4 Requirements 4.1 General Table 1 summarizes the require

28、ments to be determined for the different elastomeric auxiliaries covered by this International Standard. 4.2 Dimensions When determined in accordance with 6.2, the following dimensions of the product shall comply with the ranges stated by the manufacturer. 4.2.1 Inner diameter, Di, of elastics, chai

29、ns, ligatures and separators. 4.2.2 Outer diameter, Do, of threads, chains, ligatures and separators. 4.2.3 Link length, L, of chains. 4.2.4 Cross-section thickness, t, of elastics, chains, ligatures and separators. 4.3 Mechanical properties 4.3.1 Initial extension force When determined in accordanc

30、e with 6.3, the initial extension force, F0, shall be within the range stated by the manufacturer. 4.3.2 24 hour residual force When determined in accordance with 6.4, the 24 h residual force, F24, shall be within the range stated by the manufacturer. 4.3.3 Ultimate extension When determined in acco

31、rdance with 6.5, the ultimate extension, A, of separators shall be within or exceed the range stated by the manufacturer. Table 1 Summary of requirements Inner diameter Outer diameter Link length Cross section thickness Initial extension force 24 h residual force Ultimate extension DiDoL t F0F24A El

32、astics Threads Chains Ligatures Separators = requirement to be determined. 7 EN ISO 21606:2007 (E) 5 Sampling Samples of a single product shall be prepared for retail sale from the same batch, before their expiry date, and containing enough material to carry out the required tests. 6 Test methods 6.

33、1 Ambient conditions Force determinations shall be conducted at a temperature of (23 2) C and relative humidity of (50 10) % (unless otherwise stated, as in 6.4.2). 6.2 Dimensions 6.2.1 Apparatus 6.2.1.1 Measuring device, with an accuracy of 0,01 mm (e.g. callipers, micrometer or optical comparator)

34、 6.2.2 Procedure Select 10 specimens at random and measure the dimensions required on each sample. 6.2.3 Treatment of results When the dimensions for all 10 specimens are within the manufacturers stated range, the product is deemed to comply with the requirements of 4.2. 6.3 Initial extension force

35、 F06.3.1 Apparatus 6.3.1.1 Tensile testing machine, capable of a crosshead rate of (100 10) mm/min and an accuracy of 0,1 % for force and 0,1 mm for extension. 6.3.1.2 Test apparatus, that incorporates two half-rods or rods that are parallel to each other and normal to the direction of the force. T

36、he radii of the half-rods shall be 0,5 mm for samples with an inner diameter less than 2,0 mm (Figure 2). For all other auxiliaries the radius of the rod shall be 0,5 mm (Figure 2). This test apparatus is intended to be mounted on the tensile testing machine. 8 EN ISO 21606:2007 (E) Key 1 test half-

37、rod shape for elastomeric auxiliaries with inner diameter less than 2 mm 2 test rod shape for elastomeric auxiliaries with inner diameter equal to or greater than 2 mm Figure 2 Test apparatus for tensile test machine suitable for testing elastomeric auxiliaries 6.3.2 Procedure Select ten specimens a

38、t random and test each specimen. The test lengths are as defined in 3.7, specified in 4.2 and illustrated in Figure 1. Place the specimen over the rods of the testing apparatus. Extend the sample at a rate of 100 mm/min to 4 the test length and hold for 5 s. After 5 s, relax extension at 100 mm/min

39、to an extension of 3 the test length. Determine the force exerted in newtons at (30 2) s after reaching the latter extension. 6.3.3 Treatment of results When a test specimen breaks during testing, the specimen is considered to have failed the test. When the values for all ten tested specimens are wi

40、thin the manufacturers stated range, the material is deemed to have complied with the requirement of 4.3.1. 6.4 24 hour residual force, F246.4.1 Apparatus 6.4.1.1 Tensile testing machine, capable of a crosshead rate of (100 10) mm/min with an accuracy of 0,1 % for force and 0,1 mm for extension. 6.4

41、1.2 Support plate, with pins of 1 mm diameter set at appropriate distances as shown in Figure 3 and which may be used to extend and then maintain the specimens in the extended condition. 9 EN ISO 21606:2007 (E) Key 1 plate to support pins 2 location of pins used to extend and then maintain the spec

42、imens extended aThree times test length. bFour times test length. Figure 3 Support plate with test pins for 24 h storing of extended elastomeric auxiliaries in water 6.4.2 Procedure Select ten specimens at random and test each specimen. The test lengths are as defined in 3.7, specified in 4.2 and il

43、lustrated in Figure 1. Apply the initial extensions defined in 6.3.2 for the initial extension force and after determining the initial extension force move the extended elastomeric auxiliaries without any relaxation on to the pins on the support plate (Figure 3). With the extended state of three tim

44、es the test length applied, the specimens are to be stored on the support in water (ISO 3696:1987, Grade 3) at (37 2) C for (24 2) h. Remove the support plate maintaining the extended condition of the auxiliaries and immediately place in water (ISO 3696:1987, Grade 3) at (23 2) C for (30 2) min. The

45、n, take the support plate with the auxiliaries out of the water and transfer the specimens without relaxation on to the test rod (half-rod or rod shaped on the adaptor Figure 2), positioned apart at three times the test length. Determine the force in newton exerted at (23 2) C. Calculate the 24 h re

46、sidual force, F24, as the percentage of the initial extension force, F0. 6.4.3 Treatment of results Where a test specimen breaks during the test, the test specimen is considered to have failed the test. When the values for all ten specimens are within the manufacturers stated range, the material is

47、deemed to have complied with the requirement of 4.3.2. 10 EN ISO 21606:2007 (E) 6.5 Ultimate extension, A 6.5.1 Apparatus 6.5.1.1 Tensile testing machine, capable of a crosshead rate of (100 10) mm/min with an accuracy of 0,1 mm for extension. 6.5.2 Procedure Select ten specimens at random and test

48、each specimen. The test lengths are as defined in 3.7, specified in 4.2 and illustrated in Figure 1. Place the specimen over the rods of the test apparatus illustrated in Figure 2. Extend the sample at 100 mm/min to fracture and determine the percentage extension at break. 6.5.3 Treatment of results

49、 When the values for all ten samples are within or exceed the manufacturers stated range, the material is deemed to have complied with the requirement of 4.3.3. 7 Marking, labelling and packaging NOTE Additional information may be included at the discretion of the manufacturer or as required by legislation. 7.1 General requirements The manufacturer shall make the following readily available in the catalogue, packaging insert, labelling or other readily accessi