BS EN ISO 13017-2012 Dentistry Magnetic attachments《牙科学 磁性附着体》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13017:2012Dentistry Magnetic attachments (ISO 13017:2012)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reprodu

2、ction or networking permitted without license from IHS-,-,-BS EN ISO 13017:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation ofEN ISO 13017:2012.The UK participation in its preparation was entrusted to Technical Committee CH/106/2, Prosthodontic materials.A list of

3、 organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limi

4、ted 2012ISBN 978 0 580 65538 8 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2012.Amendments issued since publicationDate T e x t a f f

5、 e c t e dCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13017 July 2012 ICS 11.060.10 English Version Dentistry - Magne

6、tic attachments (ISO 13017:2012) Mdecine bucco-dentaire - Attaches magntiques (ISO 13017:2012) Zahnheilkunde - Magnetische Befestigungselemente (ISO 13017:2012) This European Standard was approved by CEN on 14 July 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which

7、 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 Euro

8、pean 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 ar

9、e 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, Ro

10、mania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means

11、 reserved worldwide for CEN national Members. Ref. No. EN ISO 13017:2012: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13017:2012EN ISO 13017:2012 (E) 3 Foreword Th

12、is document (EN ISO 13017:2012) 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 given the status of a national standard, either by publication of a

13、n identical text or by endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. 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 b

14、e 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: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Es

15、tonia, 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, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice Th

16、e text of ISO 13017:2012 has been approved by CEN as a EN ISO 13017:2012 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13017:2012ISO 13017:2

17、012(E)ForewordISO (the International 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 whic

18、h 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 work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all ma

19、tters 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 International Standards. Draft International Standards adopted by the technical committees are circul

20、ated 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 the elements of this document may be the subject of patent rights. ISO shall not be held responsibl

21、e for identifying any or all such patent rights.ISO 13017 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. ISO 2012 All rights reserved iiiCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo rep

22、roduction or networking permitted without license from IHS-,-,-BS EN ISO 13017:2012ISO 13017:2012(E)IntroductionThe early practical uses of permanent magnets were as navigational compasses. Magnets have since become firmly integrated into todays modern electronic device technology. The development o

23、f magnetic technology has generated rare earth magnets. Their excellent magnetic character properties permit predictable clinical applications and use. Dental magnetic attachments are one of the products composed of rare earth magnets, providing retention, support and stabilization of dental and max

24、illofacial appliances.iv ISO 2012 All rights reservedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13017:2012Dentistry Magnetic attachments1 ScopeThis International S

25、tandard specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of crowns and bridges, removable partial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial prosth

26、eses including obturators.This International Standard does not specify qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risk, which can be assessed using ISO 10993-1 and ISO 7405.2 Normative referencesThe following referenced documents are indispensabl

27、e 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 1942, Dentistry VocabularyISO 3585, Borosilicate glass 3.3 PropertiesISO 5832-1, Implants for sur

28、gery Metallic materials Part 1: Wrought stainless steelISO 10271, Dentistry Corrosion test methods for metallic materialsISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part1: General requirementsISO 22674, Dentistry Metallic mater

29、ials for fixed and removable restorations and appliancesISO/IEC 17025, General requirements for the competence of testing and calibration laboratoriesIEC 60404-8-1: Magnetic materials Part 8-1: Specifications for individual materials Magnetically hard materials3 Terms and definitionsFor the purposes

30、 of this document, the terms and definitions given in ISO 1942 and the following apply.3.1magnetic attachmentdevice to provide retention of a prosthesis utilizing magnetic attraction as shown in Figures 1 and 23.1.1open magnetic circuit attachmentmagnetic attachment which utilizes an open magnetic c

31、ircuit between coupled componentsNOTE The magnet is encased within a corrosion-resistant metal or alloy cover of titanium, titanium alloy or stainless steel to prevent corrosion of the magnet, and utilizes the attractive force between either two magnets or between a magnet and a ferromagnetic alloy

32、keeper as retentive coupling components.See Figure 1.INTERNATIONAL STANDARD ISO 13017:2012(E) ISO 2012 All rights reserved 1Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN

33、ISO 13017:2012ISO 13017:2012(E)a) Combination of a magnet and a keeper b) Combination of two magnetsKey1 magnet2 keeper3 magnet core4 coverFigure 1 Schematic diagrams of open magnetic circuit attachment3.1.2closed magnetic circuit attachmentmagnetic attachment which utilizes a closed magnetic circui

34、t between the coupled device componentsNOTE The attachment consists of a combination of a magnetic assembly and a keeper. Examples are sandwich type and cup-yoke type.See Figure 2.a) Sandwich type b) Cup-yoke typeKey1 magnetic assembly2 keeper3 yoke4 magnet core5 spacer6 coverFigure 2 Schematic diag

35、rams of closed magnetic circuit attachment3.2magnetic assemblyassembly composed of a small magnet which is sealed within ferromagnetic yokes and non-magnetic spacers, completing closed magnetic circuitsNOTE The closed magnetic circuit is a complete circulating path for magnetic flux through the yoke

36、 and keeper, which are made of ferromagnetic materials. This circuit can enhance the retentive force and reduce the magnetic flux leakage.2 ISO 2012 All rights reservedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking p

37、ermitted without license from IHS-,-,-BS EN ISO 13017:2012ISO 13017:2012(E)3.3keeperferromagnetic alloy component used to retain a prosthesisNOTE The keeper is placed across the poles of a magnet or a magnetic assembly to complete the magnetic circuit and fixed to an abutment to retain a prosthesis.

38、3.4yokeferromagnetic alloy component connected to a permanent magnet used for concentrating magnetic flux4 Requirements4.1 Material4.1.1 Magnet coreA magnet that is classified by principal constituents in accordance with IEC 60404-8-1 shall be used as the magnet core.4.1.2 Components other than the

39、magnet coreA material whose chemical composition is declared by the manufacturer shall be used for components of the dental magnetic attachment, other than the magnet core.4.1.3 Reported chemical compositionFor the magnet core, the principal constituents in accordance with IEC 60404-8-1 shall be sta

40、ted see 7 a).For the materials of the dental magnetic attachment other than the magnet core, all constituent element names that are present in excess of 1,0 % (mass fraction) shall be stated see 7 a) by reference to the manufacturers composition report. The manufacturer shall disclose the chemical c

41、omposition of an appropriate lot production, if users request it.4.2 Hazardous elements4.2.1 Recognized hazardous elementsFor the purpose of this International Standard, the elements nickel, cadmium and beryllium are designated hazardous elements.4.2.2 Permitted limits for the hazardous elements cad

42、mium and berylliumMaterials of dental magnetic attachments shall not contain more than 0,02 % (mass fraction) cadmium or beryllium.4.2.3 Manufacturers reported nickel content and permitted deviationIf the materials of the dental magnetic attachment other than the magnet core contain more than 0,1 %

43、(mass fraction) nickel, the contents shall be given to an accuracy of 0,1 % (mass fraction) in the literature which accompanies the package see 7 f) and on the package, label or insert see 8.2 d). The mass fraction shall not exceed the value stated in 7 f) and 8.2 d).4.3 Risk analysisRisk analysis s

44、hould be carried out and documented according to ISO 14971. ISO 2012 All rights reserved 3Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 13017:2012ISO 13017:2012(E)4.4

45、 Magnetic flux leakageIf the average maximum magnetic flux 5 mm from the surface of the magnetic attachment is over 40mT3, when tested in accordance with 6.2, this value shall be stated in the literature accompanying the package see 7 b).4.5 Retentive forceThe retentive force of the dental magnetic

46、attachment shall not be less than 85 % of the value stated in the literature accompanying the package see 7 d) when tested in accordance with 6.3.4.6 Corrosion resistance4.6.1 Released ionsThe total metal ions released from the magnet or the magnetic assembly and from the keeper into the specified s

47、olution (see 6.4.1.4) at (37 1) C in a time period of 7 d 1 h shall not exceed 200 gcm2in accordance with ISO 22674 when tested in accordance with 6.4.1.4.6.2 Breakdown potentialBreakdown potentials of the magnetic assembly and the keeper shall be equal to, or higher than, that of wrought stainless

48、steel in accordance with ISO 5832-1 when tested in accordance with 6.4.2.5 Preparation of test specimens5.1 Retentive forceClean the mating face on the magnet or the magnetic assembly and the keeper using a cotton bud which has been soaked in acetone, ethanol or methanol just before measurement (see 6.3.2). Dry with oil- and water-free compressed air.5.2 Static immersion testPrepare a sufficient number (at least three) of magnets, magnetic assemblies or keepers such that the total surface area is at least 2 cm2. Prepare the magnets, magnetic assembl