欢迎来到麦多课文档分享! | 帮助中心 海量文档,免费浏览,给你所需,享你所想!
麦多课文档分享
全部分类
  • 标准规范>
  • 教学课件>
  • 考试资料>
  • 办公文档>
  • 学术论文>
  • 行业资料>
  • 易语言源码>
  • ImageVerifierCode 换一换
    首页 麦多课文档分享 > 资源分类 > PDF文档下载
    分享到微信 分享到微博 分享到QQ空间

    BS ISO 7206-12-2016 en_3855 Implants for surgery Partial and total hip joint prostheses Deformation test method for acetabular shells《外科植入物 部分和全髋关节假体 髋臼杯的变形试验方法》.pdf

    • 资源ID:391318       资源大小:3.99MB        全文页数:20页
    • 资源格式: PDF        下载积分:5000积分
    快捷下载 游客一键下载
    账号登录下载
    微信登录下载
    二维码
    微信扫一扫登录
    下载资源需要5000积分(如需开发票,请勿充值!)
    邮箱/手机:
    温馨提示:
    如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
    如需开发票,请勿充值!如填写123,账号就是123,密码也是123。
    支付方式: 支付宝扫码支付    微信扫码支付   
    验证码:   换一换

    加入VIP,交流精品资源
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    BS ISO 7206-12-2016 en_3855 Implants for surgery Partial and total hip joint prostheses Deformation test method for acetabular shells《外科植入物 部分和全髋关节假体 髋臼杯的变形试验方法》.pdf

    1、BS ISO 7206-12:2016 Implants for surgery Partial and total hip joint prostheses Part 12: Deformation test method for acetabular shells BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 7206-12:2016 BRITISH STANDARD National foreword This British Standard is the

    2、 UK implementation of ISO 7206-12:2016. The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 5 0 / 4 , S u r g i c a l I m p l a n t s - B o n e a n d J o i n t Replacements. A list of organizations represented on this committee can be obtained on requ

    3、est to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 85595 5 ICS 11.040.40 Compliance with a Bri

    4、tish Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2016. Amendments/corrigenda issued since publication Date T e x t a f f e c t e dBS ISO 7206-12:2016 ISO 2016 Implants f

    5、or surgery Partial and total hip joint prostheses Part 12: Deformation test method for acetabular shells Implants chirurgicaux Prothses partielles et totales de larticulation de la hanche Partie 12: Mthode dessai de dformation des cupules actabulaires INTERNATIONAL STANDARD ISO 7206-12 First edition

    6、 2016-10-01 Reference number ISO 7206-12:2016(E)BS ISO 7206-12:2016ISO 7206-12:2016(E)ii ISO 2016 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise i

    7、n any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de

    8、 Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgBS ISO 7206-12:2016ISO 7206-12:2016(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Principle 3 5 Apparatus . 3 6 Procedur

    9、e. 5 7 Report 6 Bibliography 8 ISO 2016 All rights reserved iii Contents PageBS ISO 7206-12:2016ISO 7206-12:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standa

    10、rds 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 tak

    11、e part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In pa

    12、rticular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements o

    13、f this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see

    14、 www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformit y assessment, as well as information about ISOs adherence

    15、 to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 4, Bone and joint replacements. ISO 7206 consists of the f

    16、ollowing parts, under the general title Implants for surgery Partial and total hip joint prostheses: Part 1: Classification and designation of dimensions Part 2: Articulating surfaces made of metallic, ceramic and plastics materials Part 4: Determination of endurance properties and performance of st

    17、emmed femoral components Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components Part 10: Determination of resistance to static load of modular femoral heads Part 12: Deformation test method for acetabular components Part 13: Determination of re

    18、sistance to torque of head fixation of stemmed femoral componentsiv ISO 2016 All rights reservedBS ISO 7206-12:2016ISO 7206-12:2016(E) Introduction Press-fit fixation is currently a common method for implanting non-cemented acetabular component for total hip joint replacement. In such a press-fit sy

    19、stem, primary fixation of the acetabular component is achieved by an interference fit between the acetabular hip cup and the reamed acetabular base. 1The interference, diameter difference, leads to a certain amount of pressure between bone and acetabular component that determines the amount of fixat

    20、ion, but also causes deformation of both the bone of the acetabular base and the acetabular component. The amount of interference is specifically defined for the appropriate acetabular component. Due to the anisotropic mechanical properties of the acetabular bone, increased stiffness mainly in the r

    21、egions of ilium and ischium, 4the deformation of the acetabular component does not occur homogenously. The local deformation of the acetabular component is increased in areas where the acetabular component is in contact with bone regions of increased stiffness. Therefore, the deformed acetabular com

    22、ponent tends to get in oval shape when looking onto its front face. There are design features beside the cup-bone-interference and the bone stiffness that affect the deformation of the acetabular component. These design features include among others the cup diameter, wall thickness, material and ant

    23、i-rotation elements on the acetabular components outside as fins and grooves. 3489Screw holes and any kind of asymmetrically positioned cut-outs could also affect the cups deformation behaviour leading to differences in the amount of deformation depending on load orientation. Deformation of the acet

    24、abular component in a modular acetabular component system can affect the proper seating and locking of the articulating insert, as well as the lubrication and friction properties of the articulating surfaces, if there also occurs a deformation of the articulating spherical socket. 3 469Deformation o

    25、f the acetabular component in a monoblock cup system definitely results in a deformation of the articulating spherical socket potentially affecting lubrication and friction properties of the articulating surfaces, potentially resulting in higher wear rates and premature failure of the prosthesis sys

    26、tem. 2578Acetabular component deformation can even then affect the systems performance if the deformation itself is not recognizable for the surgeon. Therefore, it is important to ensure that the deformation of an acetabular component does not significantly affect the systems functional properties a

    27、s intraoperative assembly of components, tribology, etc. This method addresses the short-term deformation performed under laboratory conditions. It does not give a quantitative deformation limit as an acceptance criterion because there is no reliable data in the scientific literature to support such

    28、 a threshold today. It has to be considered that the test conditions described in this part of ISO 7206 do not exactly reproduce all the factors of the clinical situation. ISO 2016 All rights reserved vBS ISO 7206-12:2016BS ISO 7206-12:2016Implants for surgery Partial and total hip joint prostheses

    29、Part 12: Deformation test method for acetabular shells 1 Scope This part of ISO 7206 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so t

    30、hat the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. Furthermore, this part of ISO 7206 specifies the test parameters of press-fit acetabular components tested in accordance with this part of ISO 7206. The described m

    31、ethod is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions. The loading of the acetabular components in vivo will, in general, differ from the loading defined in this test

    32、 method. The results obtained here cannot be used to directly predict in vivo performance. This part of ISO 7206 does not cover methods of examining the test specimen. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensab

    33、le for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 2768-2, General tolerances Part 2: Geometrical tolerances for features without individual tolerance indications

    34、ISO 7206-1, Implants for surgery Partial and total hip joint prostheses Part 1: Classification and designation of dimensions ISO 7206-2, Implants for surgery Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and plastics materials ISO 21534, Non-active su

    35、rgical implants Joint replacement implants Particular requirements 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 7206-1, ISO 7206-2 and ISO 21534 and the following, apply. 3.1 metal backing deformation amount of geometrical deviation (inner diam

    36、eter and circularity of metal backing in a defined measurement plane) from design specifications under loading conditions INTERNATIONAL ST ANDARD ISO 7206-12:2016(E) ISO 2016 All rights reserved 1BS ISO 7206-12:2016ISO 7206-12:2016(E) 3.2 spherical socket deformation articulating surface deformation

    37、 amount of geometrical deviation (diameter and circularity in a defined measurement plane) from design specifications under loading conditions 3.3 frontal face reference plane plane, perpendicular to the component polar axis, nominally at the frontal face level (see Figure 1 a) Note 1 to entry: In c

    38、ase of doubt, the polar axis can be defined as perpendicular to the plane spanning around the contact zone of the acetabular component to the cortical bone, and as containing the centre point of the ball sphere approximating the acetabular components outer sphere. Note 2 to entry: In case of an asym

    39、metrically shaped front face, e.g. anatomically shaped acetabular components, the frontal face reference plane can be located at a level, which contains the largest part of the frontal face that is perpendicular to the component polar axis (see Figure 1 b) and c). Note 3 to entry: In case that the f

    40、rontal face does not contain any part perpendicular to the component axis, the frontal face reference plane can be located at that level at the approximated middle between the highest and the lowest point of the frontal face in distal direction (see Figure 1 d). a) b) c) d) NOTE Marked (shaded) area

    41、s of the frontal face are located in the reference plane. Figure 1 Frontal face reference plane of acetabular components 3.4 loading plane plane, parallel to the frontal face reference plane and located in an area where the acetabular cup gets in contact with the cortical bone after being properly a

    42、nd fully seated intraoperatively EXAMPLE For symmetrically shaped acetabular components, Figure 1 a), the loading plane will usually be located close to the frontal face reference plane.2 ISO 2016 All rights reservedBS ISO 7206-12:2016ISO 7206-12:2016(E) 3.5 measurement plane plane, parallel to the

    43、frontal face reference plane, located with a certain distance to the frontal face reference plane but as close as possible to the frontal face reference plane Note 1 to entry: The sensitivity of the deformation measurement decreases with increasing distance of the measurement plane from the front fa

    44、ce reference plane and with decreasing distance of the measurement plane to the top of the cup. Note 2 to entry: Within the measurement plane, the measurement points for determining the inner diameter of the test specimen can be captured. Therefore, the measurement plane can be defined so that captu

    45、ring the measurement points is not disturbed by any design features of the test specimen as holes or cut-outs. The measurement points can be captured at the test specimen directly; they cannot be captured at the load frame. 4 Principle The test specimen is subjected to diametrically opposite two-poi

    46、nt loading. For the determination of short-term deformation, measurements of diameter in loading direction in a defined measurement plane are carried out prior and under loading, as well as after unloading. This deformation measurement procedure is repeated two times after rotating the specimen with

    47、 rotation angles of itself, of which each rotation angle measures 120 to account for influence of asymmetric design features as fins, holes, etc. Metal-backed modular acetabular components can deform and affect the seating of the insert. The combination of metal-backing and insert can deform and aff

    48、ect the tribology. So such components shall be tested in two steps: first step, testing of the metal backing alone; second step, testing of the metal backing with the appropriately mounted bearing insert. Press-fit installation of monoblock acetabular cup components can cause deformation of the arti

    49、cular surface which may affect tribology. Such components shall be tested in only one step. 5 Apparatus 5.1 Loading device A load frame capable of the following functionality: a) shall not exhibit any visible and irreversible deformation under loading the test specimen; b) shall allow reproducible loading and unloading of a test specimen along a defined mechanical axis and measuring loads and distances, respectively; c) shall be capable of loading acetabular hip cups up t


    注意事项

    本文(BS ISO 7206-12-2016 en_3855 Implants for surgery Partial and total hip joint prostheses Deformation test method for acetabular shells《外科植入物 部分和全髋关节假体 髋臼杯的变形试验方法》.pdf)为本站会员(李朗)主动上传,麦多课文档分享仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文档分享(点击联系客服),我们立即给予删除!




    关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服 - 联系我们

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1 

    收起
    展开