EN ISO 17254-2016 en Dentistry - Coiled springs for use in orthodontics《牙科-螺旋弹簧用于正畸(ISO 17254 2016)》.pdf

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1、BS EN ISO 17254:2016Dentistry Coiled springsfor use in orthodontics (ISO17254:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 17254:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17254:2016. The UK partici

2、pation in its preparation was 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

3、. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 80474 8ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority

4、 of theStandards Policy and Strategy Committee on 31 August 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17254 August 2016 ICS 11.060.10 English Version Dentistry - Coiled springs for use in orthodontics (ISO

5、17254:2016) Mdecine bucco-dentaire - 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 whic

6、h stipulate 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 Eur

7、opean Standard 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 a

8、re the national 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, R

9、omania, 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 2016 CEN All rights of exploitation in any form and

10、 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17254:2016 EBS EN ISO 17254:2016EN ISO 17254:2016 (E) 3 European 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 “

11、Dentistry” 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 February 2017, and conflicting national standards shall be withdrawn at the latest by February 2

12、017. Attention is drawn to the possibility that 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. According to the CEN-CENELEC Internal Regulations, the national standards organiz

13、ations 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, Ma

14、lta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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. BS EN ISO 17254:2016ISO 17254:2016(E)Foreword ivIn

15、troduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 34.1 General . 34.2 Dimensions . 34.3 Mechanical properties 34.4 Hazardous elements . 35 Test methods . 35.1 Sampling . 35.2 Dimensions . 35.2.1 Apparatus . 35.2.2 Measurement procedures 35.3 Mechanical properti

16、es 45.3.1 Apparatus . 45.3.2 Measurement procedures 45.4 Treatment of results . 46 Packaging and labelling information 46.1 General requirements . 46.2 Packaging . 46.3 Labelling . 5Bibliography 6 ISO 2016 All rights reserved iiiContents PageBS EN ISO 17254:2016ISO 17254:2016(E)ForewordISO (the Inte

17、rnational Organization 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

18、 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 work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical s

19、tandardization.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 acco

20、rdance with the 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. Detail

21、s of any patent 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 endo

22、rsement.For an 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 informationThe committee respon

23、sible for this document is ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials.iv ISO 2016 All rights reservedBS EN ISO 17254:2016ISO 17254:2016(E)IntroductionThis International Standard has been developed to specify the information provided by manufacturers and suppliers to

24、help clinicians compare coiled springs.Specific qualitative and quantitative test methods 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 IS

25、O 10993-1 and ISO 7405. ISO 2016 All rights reserved vBS EN ISO 17254:2016BS EN ISO 17254:2016Dentistry Coiled springs for use in orthodontics1 ScopeThis International Standard applies to coiled springs for use in orthodontic appliances.This International Standard gives details of methods to compare

26、 the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its a

27、pplication. 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 Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 19

28、42 and the following apply.3.1inner (internal spring) diameterdimaximum outside diameter of a tube that could be contained within a coiled springNote 1 to entry: See Figure 1.Figure 1 Coiled Spring Dimensions3.2outer diameterdominimum inside diameter of a tube within which a coiled spring could be c

29、ontainedNote 1 to entry: See Figure 1.INTERNATIONAL STANDARD ISO 17254:2016(E) ISO 2016 All rights reserved 1BS EN ISO 17254:2016ISO 17254:2016(E)3.3wire cross section dimensionswdcross section dimensions of the wire used to manufacture the springNote 1 to entry: See Figure 1.3.4unloaded spring leng

30、thlucoverall 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 Figure 2.Figure 2 Coiled Springs Dimensions with Attachments.3.6total spring lengthltf

31、or 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 unloaded spring length3.8maximum extensionmaxlengthening of the spring, in percent, required

32、 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 maximum extension or compression at 80 %, 60 %, 40 %, 20 % of the maximum extension or

33、 compression2 ISO 2016 All rights reservedBS EN ISO 17254:2016ISO 17254:2016(E)4 Requirements4.1 GeneralThe manufacturer shall declare the following properties, which when tested in accordance with the test methods described in Clause 5, shall be within the ranges stated by the manufacturer.4.2 Dime

34、nsions4.2.1 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 dib) outer diameter doc) unloaded spring length luc orlued) total spri

35、ng 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 compression4.4 Hazardous elementsFor the purposes of this International S

36、tandard, 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 single product from one batch shall be procured for each test.Measuremen

37、ts 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 proceduresMeasure the following to the nearest 0,01 mm: inner diameter, di, ou

38、ter diameter, do, total length, lt, and unloaded spring length, lucor lue, per their respective definitions. ISO 2016 All rights reserved 3BS EN ISO 17254:2016ISO 17254:2016(E)5.3 Mechanical properties5.3.1 ApparatusMeasurements shall be made using a mechanical testing machine, calibrated for force

39、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 shall be in the range of 0,5 mm/min to 10,0 mm/

40、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 load, L80%max, L60%max, L40%max, L20%max, of maximu

41、m 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 requirementsThe manufacturer shall make the following readi

42、ly 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, and the mass fractions of any hazardous element

43、s 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 can be included at the discretion of the manufac

44、turer 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.4 ISO 2016 All rights reservedBS EN ISO 17254:2016ISO 17254:2016(E)6.3 Label

45、lingEach 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 springs within the package;f) a wa

46、rning for products containing hazardous elements (where appropriate, this information shouldtake the form of symbols). ISO 2016 All rights reserved 5BS EN ISO 17254:2016ISO 17254:2016(E)Bibliography1 ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry2 ISO 10993-1

47、, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process6 ISO 2016 All rights reservedBS EN ISO 17254:2016This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other

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