BS EN ISO 19490-2017 Dentistry Sinus membrane elevator《牙科 窦膜升降机》.pdf

1、Dentistry Sinus membrane elevator (ISO 19490:2017)BS EN ISO 19490:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 19490:2017. The UK participation in its preparation was entrusted to Techni

2、cal Committee CH/106/4, Dental Instruments and Equipment.A list of 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 B

3、ritish Standards Institution 2017Published by BSI Standards Limited 2017ISBN 978 0 580 85928 1ICS 11.060.25Compliance 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 Jul

4、y 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS EN ISO 19490:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 19490June 2017ICS 11.060.25EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC M

5、anagement Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 19490:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry - Sinus membrane elevator (ISO 19490:2017)Mdecine bucco-dentaire - Sinus membrane levateurs (ISO 1949

6、0:2017)Zahnheilkunde - Sinusmembranelevator (ISO 19490:2017)This European Standard was approved by CEN on 18 May 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without a

7、ny 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 official versions (English, French, German). A version in any other langua

8、ge 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 of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,

9、Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionE

10、N ISO 19490:2017 (E)European forewordThis document (EN ISO 19490:2017) 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 nationa

11、l standard, either by publication of an identical text or by endorsement, at the latest by December 2017, and conflicting national standards shall be withdrawn at the latest by December 2017.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

12、 rights. CEN 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, Croatia, Cyprus, Czec

13、h 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United

14、 Kingdom.Endorsement noticeThe text of ISO 19490:2017 has been approved by CEN as EN ISO 19490:2017 without any modification.iiBS EN ISO 19490:2017ISO 19490:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 25.1 Material of

15、 the working end 25.2 Material for the handle. 25.3 Dimensions . 25.4 Surface finish 25.5 Resistance to reprocessing . 25.6 Hardness of the working end . 25.7 Connection of shank and handle 25.8 Shape of working end 26 Test method . 46.1 Measurement of length 46.2 Test on surface finish . 46.3 Test

16、on resistance to reprocessing . 46.4 Hardness test 46.5 Connection of shank and handle 46.5.1 Test under tensile force 46.5.2 Test under torque 47 Marking 47.1 Marking on the instrument 47.2 Labelling on the package 47.3 Instructions for use . 4Bibliography 5 ISO 2017 All rights reserved iiiContents

17、 PageBS EN ISO 19490:2017ISO 19490:2017(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 b

18、ody interested in a subject for which 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 Electro

19、technical Commission (IEC) on all matters of electrotechnical standardization.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 I

20、SO documents should be noted. This document was drafted in accordance 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 re

21、sponsible for identifying any or all such patent rights. Details 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 giv

22、en for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) princi

23、ples in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee 4, Dental instruments. iv ISO 2017 All rights reservedBS EN ISO 19490:2017ISO 19490:2017(E)IntroductionA sinus memb

24、rane elevator is a dental instrument used during the placement of dental implants for sinus floor lifting to augment the vertical bone thickness. These types of sinus membrane elevator are addressed in this document. ISO 2017 All rights reserved vBS EN ISO 19490:2017This page deliberately left blank

25、Dentistry Sinus membrane elevator (ISO 19490:2017)1 ScopeThis document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.2 Normative refer

26、encesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) a

27、pplies.ISO 1942 , Dentistry VocabularyISO 6507-1 , Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1 , Metallic materials Rockwell hardness test Part 1: Test methodISO 13504:2012 , Dentistry General requirements for instruments and related accessories used in dental implant plac

28、ement and treatmentISO 15087-1 , Dental elevators Part 1: General requirementsISO 16443 , Dentistry Vocabulary for dental implants systems and related procedure3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 , ISO 13504:2012 and ISO 16443 and the

29、 following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1sinus membrane elevatorhandheld dental instrument desig

30、ned for lifting or displacing the sinus membrane (floor) by a lateral (external) or vertical approach (crestal) of the maxillary sinus in order to enable bone augmentation for insertion of an implantNote 1 to entry: A sinus membrane elevator consists of a working tip (3.3) and a shank, which is conn

31、ected to a handle. Instruments may be double-ended.3.2working endpart of the sinus membrane elevator consisting of a working tip (3.3) and a shank connected to the handle3.3working tipactive part of the working end (3.2) which will be first to engage bone and the sinus membraneINTERNATIONAL STANDARD

32、 ISO 19490:2017(E) ISO 2017 All rights reserved 1BS EN ISO 19490:2017ISO 19490:2017(E)4 ClassificationFor the purpose of this document, sinus membrane elevators shall be classified according to the approach of sinus floor lifting into the following types: Type 1: Lateral/vestibular/external approach

33、; Type 2: Vertical/crestal/internal approach.5 Requirements5.1 Material of the working endThe working end of the sinus membrane elevator shall be made of materials in accordance with ISO 13504:2012 .5.2 Material for the handleThe material for the handle of the sinus membrane elevator shall be left t

34、o the manufacturers discretion.5.3 DimensionsThe overall length is left to the manufacturers discretion.NOTE Overall lengths in excess of 178 mm can cause problems when fitting into trays and cassettes for reprocessing.5.4 Surface finishThe surfaces of the instruments shall be free of visible surfac

35、e defects when tested in accordance with 6.2.5.5 Resistance to reprocessingThere shall be no deterioration or corrosion when tested in accordance with 6.3.5.6 Hardness of the working endThe hardness of the working end for the instrument shall be equal or greater than 480 HV1 or 48 HRC when tested in

36、 accordance with 6.4.5.7 Connection of shank and handleThe sinus membrane elevator assembled with the shank and handle shall not loosen when tested at the tensile force and torque as stated under 6.5.5.8 Shape of working endThe shape of the working end and working tip is left to the discretion of th

37、e manufacturer. Figures 1 to 3 are given as example only. Other designs of working end and working tip are also possible.2 ISO 2017 All rights reservedBS EN ISO 19490:2017ISO 19490:2017(E)12321Key1 working tip2 shank3 handleFigure 1 Example of Type 112 31Key1 working tip2 shank3 handleFigure 2 Examp

38、le of Type 1Key1 working tip2 shank3 handleFigure 3 Example of Type 2 ISO 2017 All rights reserved 3BS EN ISO 19490:2017ISO 19490:2017(E)6 Test method6.1 Measurement of lengthCarry out the measurement of length with a measuring device with the accuracy of 1/10 less than tolerance.6.2 Test on surface

39、 finishPerform the visual examination with normal visual acuity and without any magnification.6.3 Test on resistance to reprocessingSubmit the instrument to 100 reprocessing cycles according to the manufacturers instructions. The reprocessing cycle shall include the manufacturers recommended methods

40、 of cleaning, disinfection and sterilization. Inspect all of the surfaces of the instrument in accordance with 6.2 for any signs of corrosion/surface defect. Repeat the test for hardness in 6.4.6.4 Hardness testTest the Vickers hardness or Rockwell hardness in accordance with ISO 6507-1 or ISO 6508-

41、1 , Annex C, respectively.6.5 Connection of shank and handle6.5.1 Test under tensile forceApply a tensile force of 1 000 N at the point where the shank is connected to the handle, parallel to the centre of the handle for 5 s in accordance with the method described in ISO 15087-1 , Annex C.6.5.2 Test

42、 under torqueApply a torque of 500 Ncm to the point where the shank is connected to the handle for 5 s in accordance with the method described in ISO 15087-1 , Annex D.7 Marking7.1 Marking on the instrumentThe instruments shall be marked in accordance with ISO 13504:2012 , 11.2.7.2 Labelling on the

43、packageLabelling on the package shall be in accordance with ISO 13504:2012 , 11.1 and 11.3.7.3 Instructions for useInstructions for use shall be in accordance with ISO 13504:2012 , 11.4 with the following additional requirements:The description shall include the reprocessing method containing cleani

44、ng, disinfection and sterilization of the instrument.4 ISO 2017 All rights reservedBS EN ISO 19490:2017ISO 19490:2017(E)Bibliography1 ISO 17664 , Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 2017 All rights r

45、eserved 5BS EN ISO 19490:2017This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Charter. British Standards and other sta

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