EN ISO 21606-2007 en Dentistry - Elastomeric auxiliaries for use in orthodontics《牙科学 正畸学用弹性体辅助装置》.pdf

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1、BRITISH STANDARDBS EN ISO 21606:2007Dentistry Elastomeric auxiliaries for use in orthodonticsThe European Standard EN ISO 21606:2007 has the status of a British StandardICS 11.060.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g

2、36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 21606:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2007 BSI 2007ISBN 978 0 580 55220 5National forewordThis British Standard is the U

3、K implementation of EN ISO 21606:2007.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can be obtained on request to its secreta

4、ry.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNOR

5、ME EUROPENNEEUROPISCHE NORMEN ISO 21606June 2007ICS 11.060.10English VersionDentistry - Elastomeric auxiliaries for use in orthodontics (ISO21606:2007)Art dentaire - Auxiliaires lastomres utiliss en orthodontie(ISO 21606:2007)Zahnheilkunde - Elastomere Elemente fr dieKieferorthopdie (ISO 21606:2007)

6、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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical reference

7、s concerning such nationalstandards 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 translationunder the responsibility of a CEN member into it

8、s own language and notified to the CEN Management Centre has 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, Lithu

9、ania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN

10、All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21606:2007: EForeword 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“,

11、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 December 2007, and conflicting national standards shall be withdrawn at the latest by December 2007. Accord

12、ing to the CEN/CENELEC Internal Regulations, the national 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

13、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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 21606:2007Reference numberI

14、SO 21606:2007(E)INTERNATIONAL STANDARD ISO21606First edition2007-06-01Dentistry Elastomeric auxiliaries for use in orthodontics Art dentaire Auxiliaires lastomres utiliss en orthodontie EN ISO 21606:2007ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and

15、 definitions. 1 4 Requirements 3 4.1 General. 3 4.2 Dimensions 3 4.3 Mechanical properties 3 5 Sampling 4 6 Test methods. 4 6.1 Ambient conditions 4 6.2 Dimensions 4 6.3 Initial extension force, F0. 4 6.4 24 hour residual force, F24. 5 6.5 Ultimate extension, A 7 7 Marking, labelling and packaging .

16、 7 7.1 General requirements. 7 7.2 Packaging and labelling. 7 Bibliography . 8 EN ISO 21606:2007iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally c

17、arried 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 represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the wor

18、k. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Inter

19、national Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of th

20、e 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 21606 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. EN ISO 21606:2007vIntroduction

21、This first edition of ISO 21606 has been developed as a 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 requirem

22、ents for freedom from biological hazards are not included 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. EN ISO 21606:2007blank1Dentistry Elastomeric auxiliaries for use in orthodontics 1 Scope

23、 This International Standard is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric 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 fol

24、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 19421), Dentistry Vocabulary ISO 3696:1987, Water fo

25、r analytical use Specification and test methods ISO 8601, Data elements and interchange formats Information interchange 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

26、 intra-oral and extra-oral elastomeric rings used to apply forces to teeth 3.2 orthodontic thread elastomeric thread (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

27、to apply forces to teeth 3.4 orthodontic elastomeric ligatures elastomeric rings used to retain wires to orthodontic 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) EN ISO 21

28、606:20072 3.6 link length L distance between the centres of the holes of adjacent links of orthodontic elastomeric 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 wit

29、hout load See Figure 1. 3.8 initial extension force F0force exerted by the elastomeric auxiliary at three times 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

30、 initial extension to four times the test length, and expressed as a percentage of the initial extension force 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 o

31、f elastomeric auxiliaries EN ISO 21606:200734 Requirements 4.1 General Table 1 summarizes the requirements 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

32、 shall comply with the ranges stated by the manufacturer. 4.2.1 Inner diameter, Di, of elastics, chains, 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

33、 and separators. 4.3 Mechanical properties 4.3.1 Initial extension force When determined in accordance 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, s

34、hall be within the range stated by the manufacturer. 4.3.3 Ultimate extension When determined in accordance 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 Cro

35、ss section thickness Initial extension force 24 h residual force Ultimate extension DiDoL t F0F24A Elastics Threads Chains Ligatures Separators = requirement to be determined. EN ISO 21606:20074 5 Sampling Samples of a single product shall be prepared for retail sale from the same batch, before thei

36、r expiry date, and containing enough material to carry out the required tests. 6 Test methods 6.1 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

37、Measuring device, with an accuracy of 0,01 mm (e.g. callipers, micrometer or optical comparator). 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

38、range, the product is deemed to comply with the requirements of 4.2. 6.3 Initial extension force, 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 t

39、wo half-rods or rods that are parallel to each other and normal to the direction of the force. The 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

40、 intended to be mounted on the tensile testing machine. EN ISO 21606:20075Key 1 test half-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 m

41、achine suitable for testing elastomeric auxiliaries 6.3.2 Procedure Select ten specimens at random and test each specimen. The test lengths are as defined in 3.7, specified in 4.2 and illustrated in Figure 1. Place the specimen over the rods of the testing apparatus. Extend the sample at a rate of 1

42、00 mm/min to 4 the test length and hold for 5 s. After 5 s, relax extension at 100 mm/min 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

43、is considered to have failed the test. When the values for all ten tested specimens are within 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

44、 rate of (100 10) mm/min with an accuracy of 0,1 % for force and 0,1 mm for extension. 6.4.1.2 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. EN ISO 21606:20076 Key

45、 1 plate to support pins 2 location of pins used to extend and then maintain the specimens 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 an

46、d test each specimen. The test lengths are as defined in 3.7, specified in 4.2 and illustrated 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

47、 on to the pins on the support plate (Figure 3). With the extended state of three times 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 an

48、d immediately place in water (ISO 3696:1987, Grade 3) at (23 2) C for (30 2) min. Then, 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

49、test length. Determine the force in newton exerted at (23 2) C. Calculate the 24 h residual 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 deemed to have complied with the requirement of 4.3.2. EN ISO 21606:200776.5 Ultimate ext