1、BRITISH STANDARD BS ISO 15142-1:2003 Implants for surgery Metal intramedullary nailing systems Part 1: Intramedullary nails ICS 11.040.40 BS ISO 15142-1:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 21 August 2003 BSI 21 August 2003 IS
2、BN 0 580 42497 9 National foreword This British Standard reproduces verbatim ISO 15142-1:2003 and implements it as the UK national standard. Together with the British Standards BS ISO 15142-2:2003 and BS ISO 15142-3:2003 it supersedes BS 3531-14.1:1990 which is withdrawn. The UK participation in its
3、 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 Bri
4、tish 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 p
5、ublication 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 interna
6、tional/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 ti
7、tle page, pages ii to v, a blank page, pages 1 to 9 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. Date Comments Reference number ISO 15142-1:2003(E) OSI 3002INTERNATIONAL STANDARD ISO 15
8、142-1 First edition 2003-08-01 Implants for surgery Metal intramedullary nailing systems Part 1: Intramedullary nails Implants chirurgicaux Systmes denclouage intramdullaire en mtal Partie 1: Clous intramdullaires BSISO151421:2003IS-24151 O1:(3002E) DPlcsid Fremia ihTs PDF file may ctnoian emdebt de
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11、 erimizde for irpnti.gn Evyre caer neeb sah taken to sneeru that the file is suitlbae fosu re yb ISO memdob rebeis. In tlnu ehikletneve y ttah lborp aem leratit gno it is f,dnuo plsaee inform ttneC ehlar Secrteiraat ta the serddaig sleb nevwo. ISO 3002 All irthgs erse.devr lnUeto sswrehise specified
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13、sopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mail coirypthgiso.o gr We bwww.is.o gro Pulbisdehi n Switlrez dnaii ISO 3002 Allr ihgtsser edevrBSISO151421:2003IS-24151 O1:(3002E) I SO 3002 All irhgts seredevr iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Norma
14、tive references. 1 3 Terms and definitions. 1 4 Materials. 4 5 Surface requirements. 4 6 Marking. 4 7 Product label. 4 8 Design requirements for insertion and removal 4 Annex A (informative) ANSI B1.1 threads 8 Bibliography . 9 BSISO151421:2003IS-24151 O1:(3002E) iv I SO 3002 All irhgts seredevrFore
15、word 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 techn
16、ical 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
17、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
18、 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
19、identifying any or all such patent rights. ISO 15142-1 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 syst
20、ems: Part 1: Intramedullary nails Part 2: Locking components Part 3: Connection devices and reamer diameter measurements BSISO151421:2003IS-24151 O1:(3002E) I SO 3002 All irhgts seredevr vIntroduction Intramedullary nailing is a method of fixation for temporary stabilization of long bones with reduc
21、ed strength due to fractures or disease or both. Because of the wide variety of the devices, some illustrations are provided in this part of ISO 15142. Medical and engineering considerations influence the design of the different devices and the choice of a device for a particular clinical situation.
22、 Nails are often, but not always, removed when they have completed their intended purpose of temporary stabilization. BSISO151421:2003blank BSISO151421:2003INTENRATIONAL TSANDADR IS-24151 O1:(3002E)I SO 3002 All irhgts seredevr 1Implants for surgery Metal intramedullary nailing systems Part 1: Intra
23、medullary nails 1 Scope This part of ISO 15142 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, defining terms and giving requirements for intramedullary nails. It is applicable to all metal intramedullary fixation devices
24、 used for temporary fixation of long bones in the human body. 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
25、(including any amendments) applies. ISO 965-1, ISO general-purpose metric screw threads Tolerances Part 1: Principles and basic data ISO 965-2, ISO general purpose metric screw threads Tolerances Part 2: Limits of sizes for general purpose external and internal screw threads Medium quality ISO 5832
26、(all parts), Implants for surgery Metallic materials ISO 14602, Non-active surgical implants Implants for osteosynthesis Particular requirements ISO 14630, Non-active surgical implants General requirements ISO 15142-3, Implants for surgery Metal intramedullary nailing systems Part 3: Connection devi
27、ces and reamer diameter measurements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. See Figures 1 to 4 for examples of various intramedullary nail types defined here. 3.1 angulated nail nail whose longitudinal axis is angulated 3.2 Bundle nails
28、3.2.1 united bundle nail nail made of a bundle of parallel rods that are fused to each other at one or more locations along the implant length BSISO151421:2003IS-24151 O1:(3002E) 2 I SO 3002 All irhgts seredevr3.2.2 un-united bundle nail nail intended for use in parallel groups so that more than one
29、 nail is usually inserted in the intramedullary cavity NOTE The individual nails are not joined to each other but may be in contact. 3.3 cannulated nail intramedullary nail that has a hole along the longitudinal axis over its full length NOTE The inner or outer contour of a hollow nail, or both cont
30、ours, can be circular, polygonal, cloverleaf, star-shaped, etc. 3.4 closed-section nail cannulated nail whose cross-sections perpendicular to the nails longitudinal axis have no discontinuities along the outer wall, other than for connection elements to accommodate locking components or insertion/re
31、moval devices 3.5 connection element integral part of the nail intended to connect the nail to a locking component or insertion/removal device EXAMPLE Hole, window, bore, slot (see Figure 5) or thread. 3.6 cross-arm auxiliary component which is used for fixation into the femoral head or metaphysis a
32、nd is intended to provide additional stability across a fracture 3.7 cross-arm intramedullary nail intramedullary nail whose function is dependent on the use of a cross-arm 3.8 curved nail nail whose longitudinal axis is curved over at least a part of its length 3.9 Diameters 3.9.1 inner diameter di
33、ameter of the largest circle which is enveloped by the contour of the cross-section of a hollow nail See Figure 4. NOTE The site of measurement is indicated if the nail is not of uniform diameter throughout its length. 3.9.2 minimum inner diameter maximum possible diameter of a guidewire of circular
34、 diameter over which the nail, which may be of variable diameter, can be passed 3.9.3 outer diameter diameter of the smallest circle that will envelop the outer cross-section of the nail See Figure 4. NOTE The site of measurement is indicated if the nail is not of uniform diameter throughout its len
35、gth. BSISO151421:2003IS-24151 O1:(3002E) I SO 3002 All irhgts seredevr 33.10 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 g
36、uide, extractor bolt or hook. 3.11 Lengths 3.11.1 effective length length of the nail as measured by the shortest distance between the two ends 3.11.2 overall length length of the nail as measured along the centreline of the nail from end to end 3.12 lockable intramedullary nail intramedullary nail
37、that has provisions for the application of locking elements to improve temporary fixation in bone See Figures 1, 2 and 3. NOTE These auxiliary components are not always used. 3.13 locking component device or component which controls or minimizes relative motion between the intramedullary nail and bo
38、ne and which is designed to fit into the connection elements of the appropriate nail EXAMPLE Screw, blade, bolt or cross-arm. 3.14 multiple component nail system nail system which consists of more than one major temporary fixation component, such as a cross-arm configurations or bundle nails 3.15 op
39、en-section nail cannulated nail whose cross-sections perpendicular to the nails longitudinal axis have one or more discontinuities along the outer wall 3.16 single-component nail system nail system that consists of one major temporary fixation component, except for locking components such as bolts/s
40、crews 3.17 solid nail nail with a solid cross-section over its entire length except for connection elements NOTE The contour can be circular, polygonal, cloverleaf, star-shaped, etc. 3.18 straight nail nail whose longitudinal axis is straight over its length BSISO151421:2003IS-24151 O1:(3002E) 4 I S
41、O 3002 All irhgts seredevr3.19 unlockable nail nail which does not have provisions for locking components See Figure 4. 4 Materials The metallic materials used for an intramedullary nail shall be chosen in accordance with ISO 14602 and the appropriate part of ISO 5832. 5 Surface requirements The sur
42、face finish shall not adversely affect the biocompatibility of the metal used. The effect of surface finish on biocompatibility shall be considered in the risk analysis for the device (see ISO 14602). NOTE The surface finish of the implant is normally selected so that it will not encourage surface b
43、one ongrowth which might make removal of the implant difficult or impossible. 6 Marking The implant shall be marked on its surface in accordance 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.
44、 7 Product label The package shall be labelled in accordance with ISO 14630. The label shall include, as a minimum, nail-specific information such as length and diameter. 8 Design requirements for insertion and removal The nail design shall reflect the insertion/removal technique. Slots shall comply
45、 with Figure 5, and accept the hooks as defined in ISO 15142-3. Standard threads in the nail should conform to metric dimensions in accordance with ISO 965-1 and ISO 965-2. NOTE Many existing nail designs utilize threadforms conforming to ANSI B1.1 designations 1/4-28, 5/16-24, 3/8-24, 7/16-20 and 9
46、/16-18. Threadforms conforming to these designations can also be used. These designations are given in Annex A for information. BSISO151421:2003IS-24151 O1:(3002E) I SO 3002 All irhgts seredevr 5Figure 1 Example of lockable, hollow nail with cross-arm for proximal femur fractures BSISO151421:2003IS-
47、24151 O1:(3002E) 6 I SO 3002 All irhgts seredevrFigure 2 Example of lockable nail, tibia and femur, solid, angulated Figure 3 Example of lockable nail, humerus and distal femur, solid, straight BSISO151421:2003IS-24151 O1:(3002E) I SO 3002 All irhgts seredevr 7Key 1 outer diameter 2 minimum inner di
48、ameter Figure 4 Example of Kuntscher nail, open, cannulated, unlockable Dimensions in millimetres aOptional linear slot to accept extractor hook. Dimensions in millimetres Nail cross-section IMFD adiameter Distance to slot Slot length Slot width X L W Cloverleaf: straight, curved, or double-ended 6
49、to 9 8 9 2,2 Cloverleaf: straight, curved, or double-ended 10 or larger 8 9 3,2 V-shaped 4 to 5 5 6 1,3 V-shaped 5,5 or larger 5 6 1,9 aIntramedullary fixation device. Figure 5 Slot connection mechanism BSISO151421:2003IS-24151 O1:(3002E) 8 I SO 3002 All irhgts seredevrAnnex A (informative) ANSI B1.1 threads See Table A.1 for ANSI screw thread diameters. Ta
