DIN EN ISO 15841-2014 Dentistry - Wires for use in orthodontics (ISO 15841 2014) German version EN ISO 15841 2014《牙科学 畸齿矫正用金属线(ISO 15841-2014) 德文版本EN ISO 15841-2014》.pdf

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1、December 2014 Translation by DIN-Sprachendienst.English price group 10No 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).I

2、CS 11.060.10!%4K“2271740www.din.deDDIN EN ISO 15841Dentistry Wires for use in orthodontics (ISO 15841:2014);English version EN ISO 15841:2014,English translation of DIN EN ISO 15841:2014-12Zahnheilkunde Drhte fr die Kieferorthopdie (ISO 15841:2014);Englische Fassung EN ISO 15841:2014,Englische berse

3、tzung von DIN EN ISO 15841:2014-12Mdecine bucco-dentaire Fils pour utilisation en orthodontie (ISO 15841:2014);Version anglaise EN ISO 15841:2014,Traduction anglaise de DIN EN ISO 15841:2014-12SupersedesDIN EN ISO 15841:2007-01www.beuth.deDocument comprises 16 pagesIn case of doubt, the German-langu

4、age original shall be considered authoritative.11.14 DIN EN ISO 15841:2014-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 15841:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (

5、Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-18 AA Kieferorthopdische Produkte. The DIN Standards corresponding to the International Standards referred to in Cla

6、use 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 6892-1 DIN EN ISO 6892-1 Amendments This standard differs from DIN EN ISO 15841:2007-01 as follows: a) Subclause 5.5 “Hazardous elements” has been extended to include cadmium and lead; b) Subclause 6.3.2 “Bend and free recovery, cal

7、ibrated to 1 C” has been added as an alternative method to determine the austenite-finish temperature; c) Clause 2 “Normative references” has been extended to include ASTM F2082. Previous editions DIN 13971: 1998-01 DIN EN ISO 15841: 2007-01 National Annex NA (informative) Bibliography DIN EN ISO 19

8、42, Dentistry Vocabulary DIN EN ISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperature EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15841 August 2014 ICS 11.060.10 Supersedes EN ISO 15841:2006English Version Dentistry - Wires for use in orthodontics (IS

9、O 15841:2014) Mdecine bucco-dentaire - Fils pour utilisation en orthodontie (ISO 15841:2014) Zahnheilkunde - Drhte fr die Kieferorthopdie(ISO 15841:2014) This European Standard was approved by CEN on 25 July 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

10、ate 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 application to the CEN-CENELEC Management Centre or to any CEN member. This European St

11、andard 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 Management Centre has the same status as the official versions. CEN members are the n

12、ational standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

13、Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any

14、means reserved worldwide for CEN national Members. Ref. No. EN ISO 15841:2014 EContents PageForeword 3Introduction 41 Scope . 52 Normative references 53 Terms and definitions . 54 Classification 65 Requirements 75.1 General . 75.2 Dimensions . 75.3 Austenite finish temperature 75.4 Mechanical proper

15、ties 75.5 Hazardous elements . 76 Test methods . 76.1 Sampling . 76.2 Dimensions . 76.3 Austenite-finish temperature . 86.4 Mechanical tests . 97 Packaging and labelling information to be provided to the user . 127.1 General requirements 127.2 Packaging 127.3 Labelling 13Bibliography .14DIN EN ISO 1

16、5841:2014-12 EN ISO 15841:2014 (E) 2 DIN EN ISO 15841:2014-12 EN ISO 15841:2014 (E) 3Foreword This document (EN ISO 15841:2014) 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. Thi

17、s 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 February 2015, and conflicting national standards shall be withdrawn at the latest by February 2015. Attention is drawn to the possibility that some of

18、 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. This document supersedes EN ISO 15841:2006. According to the CEN-CENELEC Internal Regulations, the national standards organizations of t

19、he following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Nether

20、lands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15841:2014 has been approved by CEN as EN ISO 15841:2014 without any modification. IntroductionAs with the first edition, the second edition of

21、this International Standard has been developed to help clinicians compare the wires from different manufacturers and suppliers. In particular, it has been written as a result of the development of new test methods.Specific qualitative and quantitative test methods for demonstrating freedom from unac

22、ceptable biological hazards are not included in this International Standard. For the assessment of possible biological hazards, reference can be made to ISO 10993 and ISO 7405.DIN EN ISO 15841:2014-12 EN ISO 15841:2014 (E) 4 1 ScopeThis International Standard specifies requirements and test methods

23、for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components.This International Standard gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodo

24、ntic wires, the test methods by which they can be determined, and packaging and labelling information.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cite

25、d applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperatureASTM F2082, Standard Test Method for Determination of Transformat

26、ion Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1austenite-finish temperatureTaftemperature at which the metallurgical transformation from t

27、he low-temperature martensite phase to the high-temperature austenite phase is completed3.2force deflection rateFincrement of load to produce a unit increment of deflection in the proportional region, expressed in N/mm (e.g. used in the bend test)3.3descriptorcode to identify the nominal dimension(s

28、) in thousandths of an inch without unit designation, in accordance with accepted orthodontic practice3.4diagonallargest cross-sectional dimension of a rectangular wireNote 1 to entry: See Figure 1.DIN EN ISO 15841:2014-12 EN ISO 15841:2014 (E) 5 Key1 diagonal2 height3 widthFigure 1 Dimensions of cr

29、oss section of a wire3.5multistrand wireorthodontic wire fabricated from two or more individual strands of wire that may be twisted, braided or made into a co-axial wire3.6offset bending forceFS(0,1)force measured at a permanent deflection of 0,1 mm during loading in the bend test3.7heightsmallest c

30、ross-sectional dimension of a rectangular wireNote 1 to entry: See Figure 1.3.8widthlarger of the height and width dimensions of a rectangular wireNote 1 to entry: See Figure 1.4 ClassificationFor the purposes of this document, wires are classified on the basis of their elastic behaviour.a) Type 1 w

31、ires: wires displaying linear elastic behaviour during unloading at temperatures up to 50 C.b) Type 2 wires: wires displaying nonlinear elastic behaviour during unloading at temperatures up to 50 C.DIN EN ISO 15841:2014-12 EN ISO 15841:2014 (E) 6 5 Requirements5.1 GeneralThe manufacturer shall decla

32、re the following properties, which, when tested in accordance with the test methods described in Clause 6, shall be within the ranges stated by the manufacturer.5.2 DimensionsEach cross-sectional dimension (diameter, width, height and diagonal, as applicable) of the wire shall be stated to the neare

33、st 0,01 mm. For multistrand wires, the dimensions shall be the internal dimensions of a tube that would just contain the wire.5.3 Austenite finish temperatureFor Type 2 wires, the austenite finish temperature shall be stated to the nearest 1 C. Austenite-finish temperature shall be determined in acc

34、ordance with either 6.3.1 or 6.3.2.5.4 Mechanical propertiesWhen a manufacturer states that different segments of an orthodontic wire have different mechanical properties, the results for each segment shall be tested separately and stated separately.5.4.1 Type 1 wiresThe modulus of elasticity, in gi

35、gapascals, 0,2 % proof strength, in megapascals, and percentage elongation after fracture when tested in accordance with 6.4.2, shall be stated.The force deflection rate, in newtons per millimetre, and 0,1 mm offset bending force, in newtons, when tested in accordance with 6.4.3 shall be stated.5.4.

36、2 Type 2 wiresThe force magnitudes measured during unloading at deflections of 3,0 mm, 2,0 mm, 1,0 mm and 0,5 mm and the permanent deflection after unloading, when tested in accordance with 6.4.3 shall be stated.5.5 Hazardous elementsFor the purposes of this International Standard, cadmium, berylliu

37、m, lead and nickel are designated to be hazardous elements and the manufacturer shall state the concentrations as a mass fraction expressed as a percentage.6 Test methods6.1 SamplingSix specimens of a single product from one batch shall be procured for each test. Where the manufacturer recommends he

38、at treatment prior to clinical use, that heat treatment shall be carried out according to the manufacturers instructions, before testing.6.2 DimensionsMeasurement shall be taken using callipers, micrometers, optical comparators or other devices with a accuracy of 0,005 mm.Measurements shall be made

39、on each dimension of each sample.DIN EN ISO 15841:2014-12 EN ISO 15841:2014 (E) 7 6.3 Austenite-finish temperature6.3.1 Differential scanning calorimetry apparatus, calibrated to 1 C6.3.1.1 ProcedureDetermine the austenite-finish temperature by differential scanning calorimetry according to the inst

40、ructions for the instrument.A heating rate of (10 2) C/min shall be used.Cut specimens to a length suitable for the test instrument.6.3.1.2 Determination of austenite-finish temperatureFrom the curve obtained by differential scanning calorimetry (see Figure 2), the austenite-finish temperature shall

41、 be determined from the high temperature side of the valley, as the point of intersection between the tangent drawn at the inflection point and the asymptotic line to the adjacent baseline curve. The intersection of the tangent lines is determined as the austenite-finish temperature, Taf, and is rep

42、orted in degrees Celsius.KeyX temperature, in degrees CelsiusY heat flow, in joules per secondFigure 2 Differential scanning calorimetry curve and interpretation6.3.2 Bend and free recovery, calibrated to 1 C6.3.2.1 ProcedureDetermination of the austenite-finish temperature, Taf, from bend and free

43、recovery, in accordance with ASTM F2082.6.3.2.2 Determination of austenite-finish temperatureDetermine the austenite-finish temperature, Taf, from the curve obtained by bend and free recovery, according to ASTM F2082 and report the result in degrees Celsius.DIN EN ISO 15841:2014-12 EN ISO 15841:2014

44、 (E) 8 6.4 Mechanical tests6.4.1 GeneralSamples for tensile or bend tests shall be straight. If the wire is delivered coiled, care shall be taken to straighten it. When samples are taken from preformed orthodontic archwires, the samples shall be cut from the straightest section of the archwire.6.4.2

45、 Tensile test6.4.2.1 GeneralThe tests shall be carried out in accordance with ISO 6892-1 to obtain the modulus of elasticity, 0,2 % proof strength and percentage elongation after fracture.6.4.2.2 Apparatus6.4.2.2.1 Tensile testing apparatus, calibrated for a crosshead rate and force in the range of

46、0,5 mm/min to 2,0 mm/min.6.4.2.2.2 Micrometer or equivalent instrument, with an accuracy of 0,005 mm.6.4.2.3 Procedure6.4.2.3.1 The crosshead rate shall be in the range of 0,5 mm/min to 2,0 mm/min.6.4.2.3.2 The original cross-sectional area, S0, shall be determined using a micrometer or equivalent i

47、nstrument (6.4.2.2.2) with an accuracy of 0,005 mm. For products of circular cross-section, the original cross-sectional area may be calculated from the arithmetic mean of two measurements carried out in two perpendicular directions. The original cross-sectional area may also be determined from the mass of a known length and the materials density.6.