BS 7251-12-1995 Orthopaedic joint prostheses - Specification for endurance of stemmed femoral components with application of torsion《矫形外科关节假体 带有转矩功能的有杆股骨部件的耐久性规范》.pdf

1、BRITISH STANDARD BS7251-12: 1995 ISO7206-8: 1995 Orthopaedic joint prostheses Part12: Specification for endurance of stemmed femoral components with application of torsionBS7251-12:1995 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspubl

2、ished under the authorityof the StandardsBoardand comesintoeffect on 15October1995 BSI 07-1999 The following BSI references relate to the work on this standard: Committee reference CH/25 Draft for comment 93/505052 DC ISBN 0 580 24838 0 Committees responsible for this British Standard The preparatio

3、n of this British Standard was entrusted to Technical Committee CH/25, Orthopaedic joint prostheses, upon which the following bodies were represented: Association of British Healthcare Industries British Institute of Surgical Technologists British Orthopaedic Association British Steel Industry Briti

4、sh Surgical Trades Association Department of Health Department of Trade and Industry (National Engineering Laboratory) Royal College of Surgeons of England Scottish Office Amendments issued since publication Amd. No. Date CommentsBS7251-12:1995 BSI 07-1999 i Contents Page Committees responsible Insi

5、de front cover National foreword ii Introduction 1 1 Scope 1 2 Normative reference 1 3 Test conditions 1 4 Endurance performance 1 List of references Inside back coverBS7251-12:1995 ii BSI 07-1999 National foreword This Part of BS7251 has been prepared by Technical Committee CH/25. It is identical w

6、ith ISO7206-8:1995 Implants for surgery Partial and total hip joint prostheses Part8: Endurance performance of stemmed femoral components with application of torsion, published by the International Organization for Standardization (ISO). A British Standard does not purport to include all the necessa

7、ry provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-reference International standard Corresponding British Standard ISO7206-4:1989 BS7251 Orthopaedic

8、 joint prostheses Part5:1990 Method for determination of endurance properties of stemmed femoral components of hip joint prostheses with application of torsion (Technically equivalent) Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 and 2, an insid

9、e back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.ISO7206-8:1995(E) BSI 07-1999 1 Introduction Fatigue properties are important attributes of in vivo per

10、formance of orthopaedic implants. Part4 of this International Standard provides a means of evaluating designs of femoral components of partial or total hip joint replacements but more data on different stem designs for the smallest stem sizes needs to be obtained to establish minimum loading values

11、using this test method for sizes smaller than those intended for the average size patient (in Europe). More data is also required to establish correlation of the results from this test method in relation to specific designs and materials, and to reflect developing clinical experience. 1 Scope This p

12、art of ISO7206 specifies the endurance performance of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement as determined under specified laboratory conditions by a method that includes theapplication of torsion. This part

13、 of ISO7206 does not apply to the following: a) prostheses for special clinical cases; b) prostheses for which the centreline of the stem is three-dimensionally curved and does not lie in any plane in which the axis of the neck lies. 2 Normative reference The following standard contains provisions w

14、hich, through reference in this text, constitute provisions of this part of ISO7206. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this part of ISO7206 are encouraged to investigate the possibility of applying t

15、he most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO7206-4:1989, Implants for surgery Partialand total hip joint prostheses Part4:Determination of endurance properties of stemmed femoral components with appl

16、ication of torsion. 3 Test conditions The femoral component shall be tested in its ready-for-use condition. 4 Endurance performance When tested as described in ISO7206-4, the femoral component shall not fracture during5 10 6cycles of application of a cyclic load of2kN with a minimum load of300N and

17、a maximum load of2,3kN. Neither shall the tests have been terminated before completion of the loading regime (seeISO7206-4:1989, subclause7.8) for reasons other than loosening of the specimen in the embedding medium.2 blankBS7251-12:1995 BSI 07-1999 List of references See national foreword.BS7251-12

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