EN ISO 15841-2014 en Dentistry - Wires for use in orthodontics《牙科学 畸齿矫正用金属线(ISO 15841 2014)》.pdf

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1、BSI Standards PublicationBS EN ISO 15841:2014Dentistry Wires for use inorthodonticsBS EN ISO 15841:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO15841:2014. It supersedes BS EN ISO 15841:2006 which is withdrawn.The UK participation in its preparation w

2、as entrusted to TechnicalCommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for

3、 its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 80712 1ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and

4、 Strategy Committee on 31 August 2014.Amendments issued since publicationDate Text affectedEUROPEAN 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 (ISO 15841:2014) Mdecine bucco-den

5、taire - 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 stipulate the conditions for giving

6、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 Standard exists in three officia

7、l 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 national standards bodies of Au

8、stria, 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, Slovakia, Slovenia, Spain, Swe

9、den, 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 means reserved worldwide for C

10、EN national Members. Ref. No. EN ISO 15841:2014 EBS EN ISO 15841:2014EN ISO 15841:2014 (E) 3 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” the secretariat of which is held by

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 February 2015, and conflicting national standards shall be withdrawn at the latest by February 2015.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

12、 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. This document supersedes EN ISO 15841:2006. According to the CEN-CENELEC Internal Regulations, the national standards organizati

13、ons of the 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

14、, Netherlands, 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. BS EN ISO 15841:2014ISO 15841:2014(E) ISO 2014 All ri

15、ghts reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 35.1 General . 35.2 Dimensions . 35.3 Austenite finish temperature 35.4 Mechanical properties 35.5 Hazardous elements . 36 Test methods . 36.1 Samplin

16、g . 36.2 Dimensions . 36.3 Austenite-finish temperature . 46.4 Mechanical tests . 57 Packaging and labelling information to be provided to the user 87.1 General requirements . 87.2 Packaging . 87.3 Labelling . 9Bibliography .10BS EN ISO 15841:2014ISO 15841:2014(E)ForewordISO (the International Organ

17、ization for Standardization) 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 establish

18、ed has the right to be represented 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.

19、The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the

20、 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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. Details of any patent

21、 rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an

22、explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this

23、 document is ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials.This second edition of ISO 15841 cancels and replaces the first edition (ISO 15841:2006), which has been revised to include a reference to ASTM F2082.iv ISO 2014 All rights reservedBS EN ISO 15841:2014ISO 15841:

24、2014(E)IntroductionAs with the first edition, the second edition of 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 qualitati

25、ve and quantitative test methods for demonstrating freedom from unacceptable 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. ISO 2014 All rights reserved vBS EN ISO 15841:2014BS EN

26、 ISO 15841:2014Dentistry Wires for use in orthodontics1 ScopeThis International Standard specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components.This In

27、ternational Standard gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic 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, a

28、re normatively referenced in this document and are indispensable for its application. 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 6892-1, Metallic mate

29、rials Tensile testing Part 1: Method of test at room temperatureASTM F2082, Standard Test Method for Determination of Transformation 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 i

30、n ISO 1942 and the following apply.3.1austenite-finish temperatureTaftemperature at which the metallurgical transformation from the low-temperature martensite phase to the high-temperature austenite phase is completed3.2force deflection rateFincrement of load to produce a unit increment of deflectio

31、n in the proportional region, expressed in N/mm (e.g. used in the bend test)3.3descriptorcode to identify the nominal dimension(s) in thousandths of an inch without unit designation, in accordance with accepted orthodontic practice3.4diagonallargest cross-sectional dimension of a rectangular wireNot

32、e 1 to entry: See Figure 1.INTERNATIONAL STANDARD ISO 15841:2014(E) ISO 2014 All rights reserved 1BS EN ISO 15841:2014ISO 15841:2014(E)Key1 diagonal2 height3 widthFigure 1 Dimensions of cross section of a wire3.5multistrand wireorthodontic wire fabricated from two or more individual strands of wire

33、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 cross-sectional dimension of a rectangular wireNote 1 to entry: See Figure 1.3.8widthlarger of the height and wid

34、th 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 wires: wires displaying linear elastic behaviour during unloading at temperatures up to 50 C.b) Type 2 wires: wir

35、es displaying nonlinear elastic behaviour during unloading at temperatures up to 50 C.2 ISO 2014 All rights reservedBS EN ISO 15841:2014ISO 15841:2014(E)5 Requirements5.1 GeneralThe manufacturer shall declare the following properties, which, when tested in accordance with the test methods described

36、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 nearest 0,01 mm. For multistrand wires, the dimensions shall be the internal dimensions of a tube t

37、hat 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 accordance with either 6.3.1 or 6.3.2.5.4 Mechanical propertiesWhen a manufacturer states that di

38、fferent 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 gigapascals, 0,2 % proof strength, in megapascals, and percentage elongation after fracture when

39、 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.5.4.2 Type 2 wiresThe force magnitudes measured during unloading at deflections of 3,0 mm, 2,0 mm,

40、 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, beryllium, lead and nickel are designated to be hazardous elements and the manufacturer shall state th

41、e 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 heat treatment prior to clinical use, that heat treatment shall be carried out according to the

42、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 on each dimension of each sample. ISO 2014 All rights reserved 3BS EN ISO 15841:2014ISO 15841:

43、2014(E)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 instructions for the instrument.A heating rate of (10 2) C/min shall be used.Cu

44、t 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 be determined from the high temperature side of the valley, as the point o

45、f 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 reported in degrees Celsius.KeyX temperature, in degrees CelsiusY heat flow, i

46、n 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 recovery, in accordance with ASTM F2082.6.3.2.2 Determination of austenite-

47、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.4 ISO 2014 All rights reservedBS EN ISO 15841:2014ISO 15841:2014(E)6.4 Mechanical tests6.4.1 GeneralSamples for tensi

48、le 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 Tensile test6.4.2.1 GeneralThe tests shall be carried ou

49、t 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 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 equiv