09-30193875-DC.pdf

a Date: 20 January 2009 Origin: International Latest date for receipt of comments: 30 April 2009 Project no.: 2008/03998 Responsible committee: CH/106/8 Dental implants Interested committees: Title: Draft BS ENISO 11953 Dentistry - The performance of hand torque instruments for the clinical tightening of screw-retained joints in endosseous dental implant systems Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 30 April 2009. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normally be sent. See overleaf for information on commenting. 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Direct tel: +44 (0)208 996 7462 Responsible Committee Secretary: Mr Simon Merriman (BSI) E-mail: simon.merrimanbsigroup.com Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 8.0 DPC: 09/30193875 DC Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are invited and will assist in the preparation of the consequent standard. Comments submitted will be reviewed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments received. If the international standard is approved, it is possible the text will be published as an identical British Standard. 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Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. DRAFT INTERNATIONAL STANDARD ISO/DIS 11953 © International Organization for Standardization, 2009 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATION ISO/TC 106/SC 8 Voting begins on: 2009-01-15 Secretariat: ANSI Voting terminates on: 2009-06-15 Dentistry The performance of hand torque instruments for the clinical tightening of screw-retained joints in endosseous dental implant systems Art dentaire Performance des instruments de serrage dans le cadre du serrage clinique des vis d'assemblage dans les systèmes d'implants endo-osseux dentaires ICS 11.060.15 ISO/CEN PARALLEL PROCESSING This draft has been developed within the International Organization for Standardization (ISO), and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel five-month enquiry. Should this draft be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two-month approval vote in ISO and formal vote in CEN. In accordance with the provisions of Council Resolution 15/1993 this document is circulated in the English language only. Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué en version anglaise seulement. To expedite distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at publication stage. Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au Secrétariat central de l'ISO au stade de publication. Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI ISO/DIS 11953 ii© ISO 2009 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. Copyright notice This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI ISO/DIS 11953 © ISO 2008 All rights reserved iii Contents Page Foreword iv Introduction . v 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 Classification . 2 5 Requirements . 2 5.1 General . 2 5.2 Accuracy and reproducibility . 2 5.3 Resistance to processing . 2 6 Test methods . 3 6.1 Apparatus . 3 6.1.1 Test Rig . 3 6.1.2 Implant screw . 5 6.1.3 Screwdriver tip . 5 6.2 Test Procedure. 5 6.3 Resistance to reprocessing 5 6.4 Test report 6 7 Marking and labelling 6 Bibliography 7 DRAFT 2009 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI ISO/DIS 11953 iv © ISO 2008 All rights reserved Foreword ISO (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 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 Electrotechnical Commission (IEC) on all matters 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 circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. ISO 11953 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants. This Draft International Standard cancels and replaces the Committee Draft, ISO/CD 11953, which has been technically revised. DRAFT 2009 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI ISO/DIS 11953 © ISO 2008 All rights reserved v Introduction Screw-retained joints are used widely in dental implant systems and for their integrity depend on the creation and maintenance of an appropriate clamping force. Failure of such joints is a documented clinical problem, which can have significant impact on treatment outcomes. Manually operated, suitably calibrated torque wrenches or devices are widely employed in dental implant treatment to tighten screwed joints and should be capable of providing the desired torque in a consistent manner. There is, however, some evidence that this might not always be the case. This standard has, therefore, been developed to facilitate the availability of devices that meet the necessary clinical requirements and help ensure successful clinical outcomes. DRAFT 2009 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI DRAFT INTERNATIONAL STANDARD ISO/DIS 11953 © ISO 2008 All rights reserved 1 1 Scope This International Standard specifies the requirements and test methods for hand torque instruments used for the clinical tightening of screw-retained joints in endosseous dental implant systems. This standard does not include electronically controlled devices.The Scope clause shall appear at the beginning of each document and define without ambiguity the subject of the document and the aspects covered, thereby indicating the limits of applicability of the document or particular parts of it. It shall not contain requirements. 2 Normative references The following referenced documents are indispensable 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 Vocabulary ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices 3 Terms and definitions For the purposes of this document the terms and definitions given in ISO 1942 and the following apply. 3.1 hand torque instrument a manually operated mechanical device used for the tightening of dental implants or parts of a dental implant system by displaying or limiting the rotational force of the instrument 3.2 usage a sequence of tightening and retightening operations followed by reprocessing (including disassembly, cleaning, disinfection and/or sterilization) in accordance with the manufacturers recommendations Dentistry The performance of hand torque instruments for the clinical tightening of screw-retained joints in endosseous dental implant systems DRAFT 2009 Licensed Copy: London South Bank University, South Bank University, 02/02/2009 05:34, Uncontrolled Copy, (c) BSI ISO/DIS 11953 2 © ISO 2008 All rights reserved 4 Classification Screw-retained joints are secured by a clamping force resulting from the amount of tension generated in the screw, each screw having an optimal value. Torque control using a hand-held torque wrench to which a screwdriver tip is attached, is the most widely used method in implant dentistry. The mechanical devices commonly employed utilise the following methods for torque control: Type 1 These devices have a preset break mechanism. The break mechanism design incorporates either a hinge, located close to the central long-axis of the screwdriver tip, or a clutch located around the long-axis of the screwdriver tip. The locking mechanism is held rigidly by a co