BS ISO 15142-2-2003 Implants for surgery - Metal intramedullary nailing systems - Locking components《外科植入物 金属髓内插钉系统 锁定元件》.pdf

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1、BRITISH STANDARD BS ISO 15142-2:2003 Implants for surgery Metal intramedullary nailing systems Part 2: Locking components ICS 11.040.40 BS ISO 15142-2:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 21 August 2003 BSI 21 August 2003 ISBN

2、 0 580 42496 0 National foreword This British Standard reproduces verbatim ISO 15142-2:2003 and implements it as the UK national standard. Together with the British Standards BS ISO 15142-1:2003 and BS ISO 15142-3:2003 it supersedes BS 3531-14.1:1990 which is withdrawn. The UK participation in its p

3、reparation 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 Briti

4、sh 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 pub

5、lication 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 internati

6、onal/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 titl

7、e page, pages ii to v, a blank page, pages 1 to 3 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 15142-2:2003(E) OSI 3002INTERNATIONAL STANDARD ISO 1514

8、2-2 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 BSISO151422:2003IS-24151 O2:(3002E) DPlcsid Fremia ihTs PDF file may ctnoian emdebt dedyfepca

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11、de 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, on tr

12、ap fo this lbupictaion maeb y cudorperro de tuilizi den yna form ro na ybm ynae,s lecetrinoc ro mecinahcal, inclidung tohpcoiypodna gn micrfoilm, wittuoh repmissii non writign from ietI rehSa Ot tsserdda eh ebolw or ISOs memreb i ydobn the cnuotrfo y ttseuqer ehe.r ISO cirypothg fofice saCe tsopale

13、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 edevrBSISO151422:2003IS-24151 O2:(3002E) I SO 3002 All irhgts seredevr iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative re

14、ferences. 1 3 Terms and definitions. 1 4 Classification and designation 1 5 Materials. 2 6 Surface requirements. 2 7 Marking. 2 8 Product labelling. 2 9 Drive connections for insertion and removal of locking components 2 Bibliography . 3 BSISO151422:2003IS-24151 O2:(3002E) iv I SO 3002 All irhgts se

15、redevrForeword 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 whi

16、ch 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 m

17、atters 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 cir

18、culated 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 respon

19、sible for identifying any or all such patent rights. ISO 15142-2 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 na

20、iling systems: Part 1: Intramedullary nails Part 2: Locking components Part 3: Connection devices and reamer diameter measurements BSISO151422:2003IS-24151 O2:(3002E) I SO 3002 All irhgts seredevr vIntroduction Intramedullary nailing is a method of fixation for temporary stabilization of long bones

21、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. This part of ISO 15142 addresses the locking components used for lockable metal intramedulla

22、ry 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 intended purpose of temporary stabilization. BSISO151422:2003blank BSISO151422:2003INTENRATIONAL TSANDADR IS-24151 O2:(3

23、002E)I SO 3002 All irhgts seredevr 1Implants 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 givin

24、g requirements for 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 a

25、pplication 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 5835 (all parts), Implants for surgery Metal bone screws Dimensions ISO 8319 (all parts), Orthopaedic instr

26、uments Drive connections 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: Appli

27、cation of risk analysis 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 connectio

28、n elements of the 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; BSISO151422:2003IS-24151 O2:(3002E) 2 I SO 3002 All irhgts seredevrc) expan

29、ding elements; d) other (claws, hooks, etc.). 5 Materials Locking components shall 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

30、accordance with ISO 14971-1 shall be performed in order to determine that the level 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 biocompati

31、bility of the metal used. The effect of surface finish on biocompatibility shall 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 d

32、ifficult or impossible. 7 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. 8 Product labelling The package shall be labelled in

33、accordance with ISO 14602. The label shall include, as a minimum, specific information 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

34、insertion and removal of locking components Screw and bolt locking components should 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 acc

35、ordance with ASTM F116 using recesses in accordance with ASTM F543-02. Drive connections conforming to those standards can also be used. BSISO151422:2003IS-24151 O2:(3002E) I SO 3002 All irhgts seredevr 3Bibliography 1 ASTM 1)F116, Standard Specification for Medical Screwdriver Bits 2 ASTM F543-02,

36、Standard Specification and Test Methods for Metallic Medical Bone Screws 1) American Society for Testing and Materials BSISO151422:2003BS ISO 15142-2:2003 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British

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