DIN EN ISO 13017-2016 Dentistry - Magnetic attachments (ISO 13017 2012 + Amd 1 2015) German version EN ISO 13017 2012 + A1 2015《牙科 磁性附着体(ISO 13017-2012+Amd 1-2015) 德文版本EN ISO 13107.pdf

1、May 2016 English price group 12No 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 11.060.15!%UVg“2505168www.din.deDIN

2、EN ISO 13017Dentistry Magnetic attachments (ISO 13017:2012 + Amd.1:2015);English version EN ISO 13017:2012 + A1:2015,English translation of DIN EN ISO 13017:2016-05Zahnheilkunde Magnetische Retentionselemente (ISO 13017:2012 + Amd.1:2015);Englische Fassung EN ISO 13017:2012 + A1:2015,Englische berse

3、tzung von DIN EN ISO 13017:2016-05Mdecine bucco-dentaire Attaches magntiques (ISO 13017:2012 + Amd.1:2015);Version anglaise EN ISO 13017:2012 + A1:2015,Traduction anglaise de DIN EN ISO 13017:2016-05SupersedesDIN EN ISO 13017:2012-11www.beuth.deDocument comprises 22 pagesDTranslation by DIN-Sprachen

4、dienst.In case of doubt, the German-language original shall be considered authoritative.06.16DIN EN ISO 13017:2016-05 2 A comma is used as the decimal marker. National foreword The text of ISO 13017:2012 including Amendment 1:2015 has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secr

5、etariat: SCC, Canada) and has been taken over without modification as EN ISO 13017:2012 + A1:2015 by Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Work

6、ing Committee NA 014-00-21 AA Dentalimplantate. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3585 DIN ISO 3

7、585 ISO 3696 DIN ISO 3696 ISO 5832-1 DIN ISO 5832-1 ISO 7405 DIN EN ISO 7405 ISO 10271 DIN EN ISO 10271 ISO 10993-1 DIN EN ISO 10993-1 ISO 14233 DIN EN ISO 14233 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 22674 DIN EN ISO 22674 ISO/IEC 17025 DIN EN ISO/IEC 17025 IEC 60404-8-1 DIN

8、IEC 60404-8-1 Amendments This standard differs from DIN EN ISO 13017:2012-11 as follows: a) Amendment ISO 13017:2012/Amd.1:2015 (EN ISO 13017:2012/A1:2015) has been incorporated; b) the definitions given in 3.1, 3.1.1, 3.2, 3.3 and 3.4 have been revised; c) in 6.2.1.1, the Gauss meter to be used for

9、 determining the magnetic flux leakage (6.2) is now described more clearly; d) in 6.3.1.2, the device used for determining the retentive force (6.3) has been described in more detail; e) the retentive force test (6.3) has been revised and the test procedure is now given in 6.3.4. Previous editions D

10、IN 13992: 2008-08 DIN EN ISO 13017: 2012-11 DIN EN ISO 13017:2016-05 3 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry DIN EN ISO 10271, Dentistry Corrosion test methods

11、for metallic materials DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 14233, Dentistry Polymer-based die materials DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15

12、223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 22674, Dentistry Metallic materials for fixed and removable restorations and appliances DIN EN ISO/IEC 17025, General requirements for the competence

13、 of testing and calibration laboratories DIN EN 60404-8-1, Magnetic materials Part 8-1: Specifications for individual materials Magnetically hard materials DIN ISO 3585, Borosilicate glass 3.3 Properties DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 5832-1,

14、 Implants for surgery Metallic materials Part 1: Stainless steel DIN EN ISO 13017:2016-05 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13017 July 2012 + A1 December 2015 ICS 11.060.10 English Version Dentistry Magnetic attachments (ISO 13017:2012 + Amd

15、1:2015) Mdecine bucco-dentaire Attaches magntiques (ISO 13017:2012 + Amd 1:2015) Zahnheilkunde Magnetische Retentionselemente (ISO 13017:2012 + Amd 1:2015) EN ISO 13017:2012 was approved by CEN on 2012-07-14 and Amendment A1:2015 on 2015-10-03. CEN members are bound to comply with the CEN/CENELEC In

16、ternal Regulations which 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 a

17、ny CEN member. This European 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

18、versions. CEN members are 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, Norwa

19、y, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any

20、 form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13017:2012 + A1:2015 EEN ISO 13017:2012 + A1:2015 (E) 2 Contents Page European foreword to EN ISO 13017:2012 4 !European foreword to EN ISO 13017:2012/A1:2015 5 Foreword 6 Introduction 7 1 Scope 8 2 Normative referen

21、ces 8 3 Terms and definitions . 8 4 Requirements 10 4.1 Material 10 4.1.1 Magnet core 10 4.1.2 Components other than the magnet core 10 4.1.3 Reported chemical composition . 10 4.2 Hazardous elements 10 4.2.1 Recognized hazardous elements 10 4.2.2 Permitted limits for the hazardous elements cadmium

22、and beryllium . 10 4.2.3 Manufacturers reported nickel content and permitted deviation 10 4.3 Risk analysis 11 4.4 Magnetic flux leakage . 11 4.5 Retentive force 11 4.6 Corrosion resistance . 11 4.6.1 Released ions . 11 4.6.2 Breakdown potential 11 5 Preparation of test specimens . 11 5.1 Retentive

23、force 11 5.2 Static immersion test 11 5.3 Anodic polarization . 11 6 Test methods . 12 6.1 Information, instructions and marking . 12 6.2 Magnetic flux leakage . 12 6.2.1 Apparatus 12 6.2.2 Test procedure 12 6.3 Retentive force 12 6.3.1 Apparatus 12 6.3.2 !Materials . 12 6.3.3 Fixing procedure 12 6.

24、3.4 !Test procedure“ . 13 6.4 Corrosion resistance . 15 6.4.1 Static immersion test 15 6.4.2 Anodic polarization . 16 DIN EN ISO 13017:2016-05 EN ISO 13017:2012 + A1:2015 (E) 3 7 Information and instructions for use 17 8 Marking and labelling . 17 8.1 Marking 17 8.2 Labelling. 17 Bibliography . 18 D

25、IN EN ISO 13017:2016-05 EN ISO 13017:2012 + A1:2015 (E) 4 European foreword to EN ISO 13017:2012 This 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.

26、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 January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. Attention is drawn to the possibility that some o

27、f 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 organizations of the following countries are bound to impleme

28、nt 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, Netherlands, Norway, Poland, Portugal, Romania, S

29、lovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13017:2012 has been approved by CEN as a EN ISO 13017:2012 without any modification. DIN EN ISO 13017:2016-05 EN ISO 13017:2012 + A1:2015 (E) 5 !European foreword to EN ISO 13017:2012/A1:

30、2015 This document (EN ISO 13017:2012/A1:2015) 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 Amendment to the European Standard EN ISO 13017:2012 shall be given the status

31、of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of p

32、atent 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: Austria, Belgium, Bulgaria,

33、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, Sweden, Switzerland, Turkey a

34、nd the United Kingdom. Endorsement notice The text of ISO 13017:2012/Amd 1:2015 has been approved by CEN as a EN ISO 13017:2012/A1:2015 without any modification.“ DIN EN ISO 13017:2016-05 EN ISO 13017:2012 + A1:2015 (E) 6 Foreword ISO (the International Organization for Standardization) is a worldwi

35、de 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 established has the right to be represented on tha

36、t 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. The procedures used to develop this docu

37、ment 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 editorial rules of the ISO/IEC Directiv

38、es, Part 2. 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

39、the document will be in the Introduction and/or on the ISO list of patent declarations received. 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

40、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 document is ISO/TC 106, Dentistry, Subcommittee

41、 SC 2, Prosthodontic materials. DIN EN ISO 13017:2016-05 EN ISO 13017:2012 + A1:2015 (E) 7 Introduction The early practical uses of permanent magnets were as navigational compasses. Magnets have since become firmly integrated into todays modern electronic device technology. The development of magnet

42、ic 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 maxillofaci

43、al appliances. DIN EN ISO 13017:2016-05 EN ISO 13017:2012 + A1:2015 (E) 8 1 Scope This International Standard specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of crowns and bridges, removable part

44、ial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators. This International Standard does not specify qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risk, which can be assessed u

45、sing ISO 10993-1 and ISO 7405. 2 Normative references The 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 reference

46、d document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 3585, Borosilicate glass 3.3 Properties ISO 5832-1, Implants for surgery Metallic materials Part 1: Wrought stainless steel ISO 10271, Dentistry Corrosion test methods for metallic materials !ISO 14233, Dentistry Polym

47、er-based die materials“ ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements ISO 22674, Dentistry Metallic materials for fixed and removable restorations and appliances ISO/IEC 17025, General requirements fo

48、r the competence of testing and calibration laboratories IEC 60404-8-1: Magnetic materials Part 8-1: Specifications for individual materials Magnetically hard materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1

49、 magnetic attachment !device to provide retention of a prosthesis utilizing magnetic attraction“ 3.1.1 open magnetic circuit attachment !magnetic attachment which utilizes an open magnetic circuit between the coupled device components“ NOTE !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. The attachment uses either a magnet and a ferromagnetic alloy keeper or two magnets as retentive coupl