BS-ISO-15142-3-2003.pdf

BRITISH STANDARD BS ISO 15142-3:2003 Implants for surgery Metal intramedullary nailing systems Part 3: Connection devices and reamer diameter measurements ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15142-3:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 21 August 2003 © BSI 21 August 2003 ISBN 0 580 42495 2 National foreword This British Standard reproduces verbatim ISO 15142-3:2003 and implements it as the UK national standard. Together with the British Standards BS ISO 15142-1 and BS ISO 15142-2:2003 it supersedes BS 3531-14.1:1990 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/150, Implants for surgery, to Subcommittee CH/150/5, Osteosynthesis and spinal devices, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 5 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 15142-3:2003(E) © OSI 3002 INTERNATIONAL STANDARD ISO 15142-3 First edition 2003-08-01 Implants for surgery Metal intramedullary nailing systems Part 3: Connection devices and reamer diameter measurements Implants chirurgicaux Systèmes d'enclouage intramédullaire en métal Partie 3: Dispositifs de connexion et mesurage du diamètre des alésoirs BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-24151 O3:(3002E) DPlcsid Fremia ihTs PDF file may ctnoian emdebt dedyfepcaes. 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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. 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 15142-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices. ISO 15142 consists of the following parts, under the general title Implants for surgery Metal intramedullary nailing systems: Part 1: Intramedullary nails Part 2: Locking components Part 3: Connection devices and reamer diameter measurements BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-24151 O3:(3002E) I ©SO 3002 All irhgts seredevr v Introduction Intramedullary nailing is a method of fixation for temporary stabilization of long bones with reduced strength due to fractures or disease or both. Medical and engineering considerations influence the design of the different devices and the choice of a device for a particular clinical situation. Nails are often, but not always, removed when they have completed their intended purpose of temporary stabilization. BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS-24151 O3:(3002E) I ©SO 3002 All irhgts seredevr 1 Implants for surgery Metal intramedullary nailing systems Part 3: Connection devices and reamer diameter measurements 1 Scope This part of ISO 15142 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving other requirements and dimensions for the devices used to insert, remove or both insert and remove intramedullary nails. It also provides a means of measuring reamer diameter. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except drive connections for locking elements. 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 8319 (all parts), Orthopaedic instruments Drive connections ISO 15142-2, Implants for surgery Metal intramedullary nailing systems Part 2: Locking components 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 connection element integral part of the nail intended to connect the nail to the locking component or insertion/removal device EXAMPLE Hole, window, bore, slot or thread. ISO 15142-1:2003, 3.5 3.2 insertion/removal device device external to the nail which connects temporarily to the nail through the nails connection element(s) in order to assist the insertion and/or removal of the nail EXAMPLE Driving handle, drill guide, extractor bolt or hook. ISO 15142-1:2003, 3.10 4 Classification and designation Insertion/removal devices shall be classified as either those containing a) hooks, or b) parallel external threads. BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-24151 O3:(3002E) 2 I ©SO 3002 All irhgts seredevr 5 Insertion/removal device requirements 5.1 All intramedullary nails shall have features (connection elements) which permit the attachment of instruments which aid in their insertion and removal. Such insertion/removal devices shall connect temporarily to the nail during surgery via the connection element. 5.2 The dimensions of hook connection elements for insertion/removal devices shall be in accordance with Annex A. 5.3 The dimensions of parallel external threads for insertion/removal devices should be as specified in ISO 8319 designations M4 to M12. NOTE Many existing insertion/removal devices utilize parallel external threadforms conforming to ANSI B1.1 designations 1/4-28, 5/16-24, 3/8-24, 7/16-20 and 9/16-18. Parallel external threadforms conforming to these designations can also be used. These designations are given in Annex B for information. 6 Measurement of reamer diameter The diameter of a reamer intended for use with an intramedullary nailing system shall be measured by use of a ring gauge through which the reamer will pass. The marking on the reamer shall correspond to the gauge diameter. NOTE Considerable confusion has arisen in the past because reamers were described either by their actual diameter, as measured by a ring gauge, or by the diameter of the hole produced in bone or by the diameter of the nail for which they are intended. 7 Drive connections for insertion and removal of locking components See ISO 15142-2. BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-24151 O3:(3002E) I ©SO 3002 All irhgts seredevr 3 Annex A (normative) Hook connection element dimensions See Figure A.1 and Tables A.1 and A.2. Figure A.1 Hooks Table A.1 Dimensions for hooks in cloverleaf nails Dimensions in millimetres Dimensiona Diameter range e f g 6 to 9 0 0,3 2,1 10 to 16 u 3,15 7 to 8,7 W 2 a See Figure A.1. Table A.2 Dimensions for hooks in V-shaped nails Dimensions in millimetres Dimensiona Diameter range e 0 0,1 f g 4 to 5 1,2 5,5 to 11 1,8 5 to 5,8 W 2 a See Figure A.1. BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-24151 O3:(3002E) 4 I ©SO 3002 All irhgts seredevr Annex B (informative) ANSI B1.1 parallel external threads See Table B.1 for ANSI screw thread diameters. Table B.1 Parallel external threads (as defined in ANSI B1.1) Diameter Designation inch mm 1/4-28 0,2500 6,35 5/16-24 0,3125 7,94 3/8-24 0,3750 9,53 7/16-20 0,4375 11,11 9/16-18 0,5625 14,29 BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-24151 O3:(3002E) I ©SO 3002 All irhgts seredevr 5 Bibliography 1 ANSI B1.1, Unified Inch Screw Threads (UN & UNR Thread Forms) BS ISO 151423:2003 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:55:00 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15142-3:2003 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. 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