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1、 Reference number ISO 15142-2:2003(E) ISO 2003 INTERNATIONAL STANDARD ISO 15142-2 First edition 2003-08-01 Implants for surgery Metal intramedullary nailing systems Part 2: Locking components Implants chirurgicaux Systmes denclouage intramdullaire en mtal Partie 2: lments de fixation Copyright Inter
2、national Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15142-2:2003(E) PDF disclaimer This PDF file may contain e
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5、rs 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. ISO 2003 All rights reserved. Unless otherwise s
6、pecified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright offic
7、e 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 Published in Switzerland ii ISO 2003 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical St
8、andards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15142-2:2003(E) ISO 2003 All rights reserved iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.1 4 Classificatio
9、n and designation1 5 Materials.2 6 Surface requirements.2 7 Marking.2 8 Product labelling.2 9 Drive connections for insertion and removal of locking components2 Bibliography .3 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Sta
10、ndards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15142-2:2003(E) iv ISO 2003 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodi
11、es (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
12、, 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 IS
13、O/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
14、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 15142-2 was prepared by Technical Committee ISO/TC 150, Implants fo
15、r 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 measur
16、ements Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15142-2:2003(E) ISO 2003 All rights
17、reserved 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
18、 clinical situation. This part of ISO 15142 addresses the locking components used for lockable metal intramedullary nails. Because of the wide variety of the devices, classification of the locking components is provided. Nails are often, but not always, removed when they have completed their intende
19、d purpose of temporary stabilization. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright
20、 International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 15142-2:2003(E) ISO 2003 All
21、rights reserved 1 Implants for surgery Metal intramedullary nailing systems Part 2: Locking components 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 requirements for
22、 the locking components of intramedullary nails. It is applicable to all metal intramedullary fixation devices used for temporary fixation of long bones in the human body, except unlockable nails. 2 Normative references The following referenced documents are indispensable for the application of this
23、 document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5835 (all parts), Implants for surgery Metal bone screws Dimensions ISO 8319 (all parts), Orthopaedic instruments Drive conne
24、ctions ISO 10993 (all parts), Biological evaluation of medical devices ISO 14602, Non-active surgical implants Implants for osteosynthesis Particular requirements ISO 14630, Non-active surgical implants General requirements ISO 14971-1, Medical devices Risk management Part 1: Application of risk ana
25、lysis 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 locking component device or component which controls or minimizes relative motion between the intramedullary nail and bone and which is designed to fit into the connection elements of the
26、appropriate nail EXAMPLE Screw, blade, bolt or cross-arm. ISO 15142-1:2003, 3.13 4 Classification and designation Locking components shall be classified into one of the following: a) bolts/screws; b) wires; Copyright International Organization for Standardization Provided by IHS under license with I
27、SO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15142-2:2003(E) 2 ISO 2003 All rights reserved c) expanding elements; d) other (claws, hooks, etc.). 5 Materials Locking components shal
28、l be manufactured from the same material as the intramedullary nail, or, if another material or condition or both is chosen, the biocompatibility shall be demonstrated in accordance with ISO 10993. A risk assessment in accordance with ISO 14971-1 shall be performed in order to determine that the lev
29、el of risk of corrosion is appropriate. If another metal is chosen then the effects of galvanic corrosion should be taken into account. 6 Surface requirements The surface finish shall not adversely affect the biocompatibility of the metal used. The effect of surface finish on biocompatibility shall
30、be considered in the risk analysis of the device (see ISO 14602). NOTE The surface finish of the implant is normally selected so that it will not encourage surface bone ongrowth which might make removal of the implant difficult or impossible. 7 Marking The implant shall be marked on its surface in a
31、ccordance with ISO 14630. In the case of anatomical shaping or orientation (left or right) of the device, there shall be a unique marking to avoid wrong positioning. 8 Product labelling The package shall be labelled in accordance with ISO 14602. The label shall include, as a minimum, specific inform
32、ation such as length and diameter. If the locking component is required to be used with an intramedullary nail of a specific metallic composition, then its metallic composition should be stated. 9 Drive connections for insertion and removal of locking components Screw and bolt locking components sho
33、uld be inserted or removed with screwdrivers in accordance with ISO 8319, using a recess in accordance with ISO 5835. NOTE Many existing locking components are designed to be inserted or removed with screwdrivers in accordance with ASTM F116 using recesses in accordance with ASTM F543-02. Drive conn
34、ections conforming to those standards can also be used. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from I
35、HS -,-,- ISO 15142-2:2003(E) ISO 2003 All rights reserved 3 Bibliography 1 ASTM1) F116, Standard Specification for Medical Screwdriver Bits 2 ASTM F543-02, Standard Specification and Test Methods for Metallic Medical Bone Screws 1) American Society for Testing and Materials Copyright International O
36、rganization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15142-2:2003(E) ICS 11.040.40 Price based on 3 pages ISO 2003 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 20:10:55 MDTNo reproduction or networking permitted without license from IHS -,-,-