DIN EN ISO 17254-2016 Dentistry - Coiled springs for use in orthodontics (ISO 17254 2016) German version EN ISO 17254 2016《牙科 正畸用螺旋弹簧(ISO 17254-2016) 德文版本EN ISO 17254-2016》.pdf

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1、December 2016 English price group 9No 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).ICS 11.060.10!%“2595791www.din.deDIN

2、 EN ISO 17254Dentistry Coiled springs for use in orthodontics (ISO 17254:2016);English version EN ISO 17254:2016,English translation of DIN EN ISO 17254:2016-12Zahnheilkunde Spiralfedern fr die Kieferorthopdie (ISO 17254:2016);Englische Fassung EN ISO 17254:2016,Englische bersetzung von DIN EN ISO 1

3、7254:2016-12Mdecine buccodentaire Ressorts hlicodaux usage orthodontique (ISO 17254:2016);Version anglaise EN ISO 17254:2016,Traduction anglaise de DIN EN ISO 17254:2016-12www.beuth.deDocument comprises 13 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall b

4、e considered authoritative.11.16 DIN EN ISO 17254:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17254:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Ge

5、rmany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-18 AA Kieferorthopdische Produkte. The DIN Standard corresponding to the International Standard referred to in this document is as follows:

6、ISO 1942 DIN EN ISO 1942 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17254 August 2016 ICS 11.060.10 English Version Dentistry - Coiled springs for use in orthodontics(ISO 17254:2016) Mdecine bucco-dentai

7、re - Ressorts hlicodaux usage orthodontique (ISO 17254:2016) Zahnheilkunde - Spiralfedern fr die Kieferorthopdie (ISO 17254:2016) This European Standard was approved by CEN on 15 July 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for g

8、iving 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 o

9、fficial 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

10、 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, Slovakia, Slovenia, Spai

11、n, 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 2016 CEN All rights of exploitation in any form and by any means reserved worldwide

12、 for CEN national Members. Ref. No. EN ISO 17254:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Requirements 84.1 General . 84.2 Dimensions . 84.3 Mechanical properties 84.4 Hazardous elements . 85 Test methods . 85.1 Sampling . 85.2 Dimension

13、s . 85.2.1 Apparatus . 85.2.2 Measurement procedures 85.3 Mechanical properties 95.3.1 Apparatus . 95.3.2 Measurement procedures 95.4 Treatment of results . 96 Packaging and labelling information 96.1 General requirements . 96.2 Packaging . 96.3 Labelling 10Bibliography . 11Contents Page2DIN EN ISO

14、17254:2016-12 EN ISO 17254:2016 (E) Foreword .4European foreword This document (EN ISO 17254:2016) 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 Standard shall be

15、given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2017, and conflicting national standards shall be withdrawn at the latest by February 2017. Attention is drawn to the possibility that some of the elements of this documen

16、t 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 organizations of the following countries are bound to implement this European Standard: Aus

17、tria, 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, Swed

18、en, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17254:2016 has been approved by CEN as EN ISO 17254:2016 without any modification. DIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) 3 ForewordISO (the International Organization for Standardization) is a worldwide feder

19、ation 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 represented on that commit

20、tee. 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.The procedures used to develop this document and

21、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 editorial rules of the ISO/IEC Directives, Part

22、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 rights identified during the development of the

23、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 explanation on the meaning of ISO specific terms

24、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 informationThe committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee S

25、C 1, Filling and restorative materials.4DIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) IntroductionThis International Standard has been developed to specify the information provided by manufacturers and suppliers to help clinicians compare coiled springs.Specific qualitative and quantitative test me

26、thods for demonstrating freedom from unacceptable biological hazard are not included in this International Standard, but for the assessment of possible biological or toxicological hazards, reference can be made to ISO 10993-1 and ISO 7405.DIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) 5 1 ScopeThis

27、International Standard applies to coiled springs for use in orthodontic appliances.This International Standard gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requiremen

28、ts.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 cited applies. For undated references, the latest edition of the referenced document (including any ame

29、ndments) applies.ISO 1942, Dentistry Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1inner (internal spring) diameterdimaximum outside diameter of a tube that could be contained within a coiled springNote 1 to

30、 entry: See Figure 1.Figure 1 Coiled Spring Dimensions3.2outer diameterdominimum inside diameter of a tube within which a coiled spring could be containedNote 1 to entry: See Figure 1.6DIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) 3.3wire cross section dimensionswdcross section dimensions of the wi

31、re used to manufacture the springNote 1 to entry: See Figure 1.3.4unloaded spring lengthlucoverall length in the unloaded positionNote 1 to entry: See Figure 1.3.5unloaded spring lengthluemaximum dimension including the hooks, eyelets or connection means in the unloaded positionNote 1 to entry: See

32、Figure 2.Figure 2 Coiled Springs Dimensions with Attachments.3.6total spring lengthltfor springs with attachments, maximum dimension including the hooks, eyelets or connection means in the unloaded position.3.7maximum compressioncmaxpercentage of the spring at complete compression against the unload

33、ed spring length3.8maximum extensionmaxlengthening of the spring, in percent, required to produce a permanent deflection of 1 % of the unloaded spring length3.9spring loadL80%max, L60%max, L40%max, L20%maxforce exerted by the spring on the return (unloading) cycle following loading to the specified

34、maximum extension or compression at 80 %, 60 %, 40 %, 20 % of the maximum extension or compressionDIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) 7 4 Requirements4.1 GeneralThe manufacturer shall declare the following properties, which when tested in accordance with the test methods described in Clau

35、se 5, shall be within the ranges stated by the manufacturer.4.2 Dimensions4.2.1 The following dimensions shall be stated to the nearest 0,01 mm. When determined according to Clause 5, the following dimensions of the product shall comply with the ranges stated by the manufacturer:a) inner diameter di

36、b) outer diameter doc) unloaded spring length luc orlued) total spring length lt4.3 Mechanical properties4.3.1 Measure the elastic behaviour during unloading:a) maximum extension, maxb) maximum compression, cmaxc) spring load, L80%max, L60%max, L40%max, and L20%max, of the maximum extension or compr

37、ession4.4 Hazardous elementsFor the purposes of this International Standard, cadmium, beryllium, lead, and nickel are designated to be hazardous elements and the manufacturer shall state the concentrations as a mass fraction expressed as a percentage.5 Test methods5.1 SamplingSix specimens of a sing

38、le product from one batch shall be procured for each test.Measurements shall be made on each dimension of each specimen.5.2 Dimensions5.2.1 ApparatusMeasurements shall be taken with calipers, micrometers, optical comparators, or other devices with an accuracy of 0,005 mm.5.2.2 Measurement procedures

39、Measure the following to the nearest 0,01 mm: inner diameter, di, outer diameter, do, total length, lt, and unloaded spring length, lucor lue, per their respective definitions.8DIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) 5.3 Mechanical properties5.3.1 ApparatusMeasurements shall be made using a m

40、echanical testing machine, calibrated for force and displacement at a crosshead rate in the range of 0,5 mm/min to 10,0 mm/min.5.3.2 Measurement procedures5.3.2.1 Tests shall be performed at (23 2) C except for temperature sensitive springs that shall be tested at (36 1) C.5.3.2.2 The crosshead rate

41、 shall be in the range of 0,5 mm/min to 10,0 mm/min.5.3.2.3 The length of the specimen shall be taken as (20 0,2) mm or the unloaded spring length if less than 20 mm.5.3.2.4 Determine the following mechanical behaviour of the springs:a) maximum extension, maxb) maximum compression, cmaxc) spring loa

42、d, L80%max, L60%max, L40%max, L20%max, of maximum extension or compression5.4 Treatment of resultsThe test results of each specimen shall be within the manufacturers specified range in order for the material to comply with the requirements.6 Packaging and labelling information6.1 General requirement

43、sThe manufacturer shall make the following readily available in the catalogue, packaging insert, labelling or other readily accessible means:a) declaration of chemical composition: the range of composition of the alloy shall include all elements present at concentrations of 0,1 % by mass or greater,

44、 and the mass fractions of any hazardous elements as defined in 4.4;b) the range of each dimension shall be in accordance with 5.2;c) spring design i.e., Compression (open) or Extension (closed);d) the range of each mechanical property shall be in accordance with 5.3.2.4.NOTE Additional information

45、can be included at the discretion of the manufacturer or as required by legislation.6.2 PackagingAdequate containment and protection from contamination during transit and storage shall be provided in accordance with acceptable commercial practice and for the intended use.DIN EN ISO 17254:2016-12 EN

46、ISO 17254:2016 (E) 9 6.3 LabellingEach package shall be labelled with at least the following information:a) the name and address of the manufacturer and, where applicable, of the distributor;b) the name or trade name of the spring;c) the design of the spring;d) the lot number;e) the quantity of spri

47、ngs within the package;f) a warning for products containing hazardous elements (where appropriate, this information should take the form of symbols).10DIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) Bibliography1 ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry2 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processDIN EN ISO 17254:2016-12 EN ISO 17254:2016 (E) 11