EN ISO 19023-2018 en Dentistry - Orthodontic anchor screws.pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Dentistry - Orthodontic anchor screws (ISO 19023:2018)BS EN ISO 19023:2018National forewordThis British Standard is the UK implementation of EN ISO 19023:2018. It is identical to ISO 19023:2018.The UK participation in i

2、ts preparation was entrusted to Technical Committee CH/106/1, Dental restorative and orthodontic materials.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

3、are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 83588 9ICS 11.060.10Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of t

4、he Standards Policy and Strategy Committee on 31 March 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 19023:2018EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 19023February 2018ICS 11.060.10EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE

5、NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2018 CEN Ref. No. EN ISO 19023:2018: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersDentistry - Orthodontic anchor screws (ISO 19023:2018)M

6、decine bucco-dentaire - Vis dancrage orthodontiques (ISO 19023:2018)Zahnheilkunde - Kieferorthopdische Ankerschrauben (ISO 19023:2018)This European Standard was approved by CEN on 2 February 2018.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions

7、 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 exists in th

8、ree 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 standards bo

9、dies 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, Serbia, Slovakia, Sl

10、ovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 19023:2018 (E)European forewordThis document (EN ISO 19023:2018) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of whic

11、h 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 August 2018, and conflicting national standards shall be withdrawn at the latest by August 2018.Attention is drawn to the possibili

12、ty that some of the elements of this document may be the subject of patent 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

13、 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, Ser

14、bia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 19023:2018 has been approved by CEN as EN ISO 19023:2018 without any modification.2BS EN ISO 19023:2018ISO 19023:2018Foreword ivIntroduction v1 Scope . 12 Normative references 13 Term

15、s and definitions . 14 Symbols and abbreviated terms . 25 Requirements 25.1 General . 25.2 Materials . 35.3 Hazardous elements . 35.4 Dimensions . 35.5 Torsional performance . 35.6 Reporting of results 36 Test methods . 36.1 Dimensions . 36.2 Torsional performance fracture torque 36.3 Torsional perf

16、ormance insertion torque . 37 Information to be provided to the user 47.1 General requirements . 47.2 Instructions for use . 47.3 Labelling . 57.4 Packaging . 5Bibliography 6 ISO 2018 All rights reserved iiiContents PageBS EN ISO 19023:2018ISO 19023:2018ForewordISO (the International Organization fo

17、r 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 been established has the

18、 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 standardization. The proce

19、dures 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 accordance with the editoria

20、l 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. Details of any patent rights i

21、dentified 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 endorsement. For an explanat

22、ion 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) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/f

23、oreword.html.This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials.iv ISO 2018 All rights reservedBS EN ISO 19023:2018ISO 19023:2018IntroductionOrthodontic anchor screws for temporary skeletal anchorage of orthodontic appliances

24、 are considered as auxiliary orthodontic devices.Orthodontic anchor screws are medical devices used in dentistry. Unlike implants, such as endosseous dental implants, which are intended to remain permanently inside the bone and where, therefore, osseointegration is desired, orthodontic anchor screws

25、 are removed at the end of the orthodontic treatment. Insertion and removal of orthodontic anchor screws require the appropriate instruments and adapters.This document has been developed as a result of the difficulty often encountered by clinicians to make meaningful comparisons between orthodontic

26、anchor screws using the information currently available from manufacturers and suppliers.Thus the purpose of this document is to facilitate communication between manufacturers and clinicians which will allow comparison between various orthodontic anchor screws.Specific qualitative and quantitative t

27、est methods for demonstrating freedom from unacceptable biological hazard are not included in this document, but it is recommended that, for the assessment of possible biological or toxicological hazards, reference should be made to ISO 10993-1 and ISO 7405. ISO 2018 All rights reserved vBS EN ISO 1

28、9023:2018This page deliberately left blankDentistry - Orthodontic anchor screws (ISO 19023:2018)1 ScopeThis document specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment.This document gives details of methods to compare physical and mechanical propertie

29、s of orthodontic anchor screws together with test methods and packaging and labelling information.NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dent

30、al implants, they are, therefore inserted into the maxillo-facial bone structures.2 Normative referencesThe 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.

31、 For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titaniumISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-alumini

32、um 4-vanadium alloyISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)ASTM F136, Standard Specification for

33、 Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws3 Terms and definitionsFor the purposes of this document, the terms and definitions given in IS

34、O 1942 and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at https:/www.electropedia.org/ ISO Online browsing platform: available at https:/www.iso.org/obp3.1orthodontic anchor screwscrew for tempor

35、ary skeletal anchorage of orthodontic appliances3.2shaftpart of the orthodontic anchor screw intended to be inserted into the bone, with at least a threaded portionINTERNATIONAL STANDARD ISO 19023:2018 ISO 2018 All rights reserved 1BS EN ISO 19023:2018ISO 19023:20183.3necktransgingival section betwe

36、en the shaft and the head of the orthodontic anchor screw3.4headpart of the orthodontic anchor screw intended for connection with the orthodontic appliance3.5insertion modemanner of insertion of an orthodontic anchor screw into the bone4 Symbols and abbreviated termsThe symbols and abbreviated terms

37、 illustrated in Figure 1 have the following meaning:d1major thread diameter;d2minor thread diameter;d3largest cross sectional dimension of the anchor screw;k1height of head;k2height of neck;l1overall length;l2shaft length;l3thread length.NOTE The shape illustrated in Figure 1 is an example, and not

38、a requirement.Figure 1 Example for designation of dimensions of orthodontic anchor screw5 Requirements5.1 GeneralThe manufacturer shall declare the properties specified in 5.2 to 5.5.The properties shall be within the ranges stated by the manufacturer.The properties shall be tested in accordance wit

39、h the test methods described in Clause 6.2 ISO 2018 All rights reservedBS EN ISO 19023:2018ISO 19023:20185.2 MaterialsThe material shall conform to either ISO 5832-2, ISO 5832-3, ASTM F67 or ASTM F136. Otherwise the range of composition of the material shall include all components present at concent

40、rations of 0,1 % by mass or greater.5.3 Hazardous elementsFor the purposes of this document, 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.5.4 DimensionsThe dimensions illu

41、strated in Figure 1, if available, shall be specified by the manufacturer.The dimensions shall be within the range stated by the manufacturer.Measure the dimensions in accordance with 6.1.5.5 Torsional performanceThe fracture torque and the insertion torque under worst case conditions shall be speci

42、fied.Test in accordance with 6.2 and 6.3.5.6 Reporting of resultsThe test results of each specimen shall be within the manufacturers specified range or tolerance in order for the anchor screw to comply with the requirements.6 Test methods6.1 DimensionsMeasurements shall be taken with suitable measur

43、ing devices, e.g. calliper, micrometer, or other devices with an accuracy of 0,05 mm.6.2 Torsional performance fracture torqueThe fracture torque of an orthodontic anchor screw shall be measured with an apparatus according to ASTM F543-17, test method A1.The maximum torque shall be delivered. The ac

44、curacy shall be in accordance with ASTM F543-17.Five specimens shall be tested.6.3 Torsional performance insertion torqueThe insertion torque of an orthodontic anchor screw shall be measured with an apparatus according to ASTM F543-17, test method A1. A segment of artificial bone shall be selected a

45、s test body to insert the anchor screw. Sawbones(Sawbones USA, Vashon Island, WA 98070)1)is an example of a synthetic bone analogue. Select the material with highest available density to simulate maximum bone density. State the density used and the respective bone density according to ASTM F-1839-08

46、.1) This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of the product or supplier named. ISO 2018 All rights reserved 3BS EN ISO 19023:2018ISO 19023:2018The screw shall be inserted following the recommendations of the manufacturer in

47、 the instructions for use regarding predrilling.The maximum torque shall be delivered. The insertion torque shall not be higher than the fracture torque. The accuracy shall be in accordance with ASTM F543-17.Five specimens shall be tested.7 Information to be provided to the user7.1 General requireme

48、ntsThe manufacturer shall provide the following information in an easily accessible manner, e.g. in the catalogue, electronically (e.g. website, DVD) or by other easily accessible means:a) manufacturers name and address;b) commercial name of the orthodontic anchor screw;c) intended use;d) major thre

49、ad diameter;e) thread length;f) overall length;g) applied standard including grade for material, or material composition.7.2 Instructions for useEach package of an orthodontic anchor screw shall be accompanied by instructions for use. Alternatively instructions for use may be provided electronically if allowed by national or regional legislation or regulation.The instructions for use shall include at least the following information:a) manufacturers name and address;b) trade name of the orthodontic anchor screw;c) intended use;d)