EN ISO 13017-2012 en Dentistry - Magnetic attachments (Incorporates Amendment A1 2015)《牙科 磁性附着体》.pdf

1、BSI Standards PublicationBS EN ISO 13017:2012+A1:2015Dentistry Magnetic attachments BS EN ISO 13017:2012+A1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13017:2012+A1:2015. It supersedes BS EN ISO 13017:2012 which is withdrawn.The start and finish of

2、 text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/106, Den

3、tistry, to Subcommittee CH/106/2, Prosthodontic materials.A list of organizations represented on this subcommittee 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. T

4、he British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 84497 3ICS 11.060.10Compliance 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

5、31 August 2012.Amendments/corrigenda issued since publicationDate Text affected31 January 2016 Implementation of ISO amendment 1:2015 with CEN endorsement A1:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13017 July 2012 ICS 11.060.10 English Version Dentistry - Magnetic attachments (I

6、SO 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 stipulate the con

7、ditions 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 European Standard exis

8、ts 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 are the national sta

9、ndards 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, Romania, Slovakia, S

10、lovenia, 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 reserved worldwid

11、e for CEN national Members. Ref. No. EN ISO 13017:2012: EEN ISO 13017:2012+A1December 2015BS EN ISO 13017:2012EN ISO 13017:2012 (E) 3 Foreword This document (EN ISO 13017:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentis

12、try” 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 January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. Att

13、ention 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 organizations o

14、f 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, Net

15、herlands, Norway, Poland, Portugal, Romania, Slovakia, 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. BS EN ISO 13017:2012+A1:2015EN ISO 13017:2012+A1:2015 (E

16、)Foreword to amendment A1This 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 b

17、e given the status 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 b

18、e 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: Austria, Be

19、lgium, 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, Sweden, Swit

20、zerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 13017:2012/Amd 1:2015 has been approved by CEN as EN ISO 13017:2012/A1:2015 without any modification.BS EN ISO 13017:2012ISO 13017:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federatio

21、n 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 committee.

22、 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.International Standards are drafted in accordance wit

23、h 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 circulated to the member bodies for voting. Publication as an International Standard requires approva

24、l 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 responsible for identifying any or all such patent rights.ISO 13017 was prepared by Technical Committee I

25、SO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. ISO 2012 All rights reserved iii ISO 2015 All rights reservedBS EN ISO 13017:2012+A1:2015ISO 13017:2012+A1:2015 (E)BS EN ISO 13017:2012ISO 13017:2012(E)IntroductionThe early practical uses of permanent magnets were as navigational com

26、passes. Magnets have since become firmly integrated into todays modern electronic device technology. The development of magnetic technology has generated rare earth magnets. Their excellent magnetic character properties permit predictable clinical applications and use. Dental magnetic attachments ar

27、e one of the products composed of rare earth magnets, providing retention, support and stabilization of dental and maxillofacial appliances.iv ISO 2012 All rights reservedBS EN ISO 13017:2012+A1:2015ISO 13017:2012+A1:2015 (E) ISO 2015 BS EN ISO 13017:2012ISO 13017:2012(E)IntroductionThe early practi

28、cal uses of permanent magnets were as navigational compasses. Magnets have since become firmly integrated into todays modern electronic device technology. The development of magnetic technology has generated rare earth magnets. Their excellent magnetic character properties permit predictable clinica

29、l applications and use. Dental magnetic attachments are one of the products composed of rare earth magnets, providing retention, support and stabilization of dental and maxillofacial appliances.iv ISO 2012 All rights reservedBS EN ISO 13017:2012Dentistry Magnetic attachments1 ScopeThis International

30、 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 partial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial pros

31、theses 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 indispensa

32、ble 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 s

33、urgery 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 mat

34、erials 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 purpos

35、es 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

36、 circuit 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 allo

37、y keeper as retentive coupling components.See Figure 1.INTERNATIONAL STANDARD ISO 13017:2012(E) ISO 2012 All rights reserved 1BS EN ISO 13017:2012Dentistry Magnetic attachments1 ScopeThis International Standard specifies requirements and test methods for assessing the applicability of dental magneti

38、c attachments that provide retention, support and stabilization of crowns and bridges, removable partial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.This International Standard does not specify qualitative and quantitati

39、ve 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 indispensable for the application of this document. For dated references, only the edition cited applies. For

40、 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 surgery Metallic materials Part 1: Wrought stainless steelISO 10271, Dentistry Corrosion test method

41、s 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 materials for fixed and removable restorations and appliancesISO/IEC 17025, General requirements for t

42、he 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 of this document, the terms and definitions given in ISO 1942 and the following apply.3.1magneti

43、c 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 circuit between coupled componentsNOTE The magnet is encased within a corrosion-resistant metal or

44、 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 keeper as retentive coupling components.See Figure 1.INTERNATIONAL STANDARD ISO 13017:2012(E) ISO

45、 2012 All rights reserved 1BS EN ISO 13017:20121 his International tandard specifies require ents and test ethods for assessing the applicability of dental agnetic attac ents that provide retention, support and stabilization of cro ns and bridges, re ovable partial dentures, overdentures, superstruc

46、tures of dental i plants and orthodontic or axillofacial prostheses includi g obturators.his International tandard does not specify qualitative and quantitative test ethods for de onstrating freedom from unacceptable biological risk, which can be assessed using ISO 10993-1 and ISO 7405.2 he follo in

47、g referenced docu ents are indispensable for the application of this docu ent. or dated references, only the edition cited applies. or undated references, the latest edition of the referenced docu ent (including any a end ents) applies.ISO 1942, entistry VocabularyISO 3585, orosilicate glass 3.3 Pro

48、pertiesISO 5832-1, I plants for surgery Metallic materials Part 1: Wrought stainless steelISO 10 71, entistry Corrosion test methods for metallic materialsISO 15223-1, edical devices Sy bols to be used with medical device labels, labelling and infor tion to be supplied Part1: General require entsISO

49、 22674, entistry Metallic mat rials for fixed and re ovable restorations and appliancesI /I C 17025, eneral require ents for the co petence of testing and calibration laboratoriesI C 60404-8-1: agnetic terials art 8-1: pecifications for individual terials agnetically hard terials3 erms and definitioor the purposes of this docu ent, the ter s and definitions given in ISO 1942 and the follo ing apply.3.1a etic attac entdevice to provide retention of a prosthesis utilizing magnetic attraction