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YY/T 0809 consists of the following 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 3: (Reserved);
——Part 4: Determination of endurance properties and performance of stemmed femoral components;
——Part 5: (Reserved);
——Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components;
——Part 7: (Reserved);
——Part 8: Endurance performance of stemmed femoral components with application of torsion;
——Part 9: (Reserved);
——Part 10: Determination of resistance to static load of modular femoral heads;
——Part 11:
——Part 12: Deformation test method for acetabular shells;
——Part 13: Determination of resistance to torque of head fixation of stemmed femoral components.
This is Part 12 of YY/T 0809.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
?
This standard has been redrafted and modified in relation to ISO 7206-12: 2016 Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells.
The following main technical changes have been made with respect to ISO 7206-12:2016:
——The adjustment on technical differences are made for the normative references of this Part to adapt to the technical conditions in China. The adjustments are mainly reflected in clause 2 "Normative references", which are shown as follows:
? ISO 2768-2 is replaced by GB/T 1184 which is adjusted into the Bibliography.
? ISO 21534 is replaced by GB/T 12417.2, which is identical to the international standard;
? ISO 7206-1 is replaced by YY/T 0809.1, which is identical to the international standard;
? ISO 7206-2 is replaced by YY/T 0809.2, which is modified in relation to the international standard;
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of SAC/TC 110/SC 1 the Subcommittee on Orthopaedic Implants of the National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China.
Implants for surgery - Partial and total hip joint prostheses -
Part 12: Deformation test method for acetabular shells
1 Scope
This part of YY/T 0809 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 that 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 specifies the test parameters of press-fit acetabular components tested in accordance with this part.
The test method 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 method. The results obtained here cannot be used to directly predict in vivo performance.
This part does not cover methods of examining the test specimen.
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 (including any amendments) applies.
GB/T 12417.2 Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants (GB/T 12417.2-2008, ISO 21534: 2002, IDT)
YY/T 0809.1 Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions (YY/T 0809.1-2010, ISO 7206-1: 2008, IDT)
YY/T 0809.2 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials (YY/T 0809.2-2010, ISO 7206-2: 1996, MOD)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in YY/T 0809.1, YY/T 0809.2 and GB/T 12417.2 and the following, apply.
3.1
metal backing deformation
amount of geometrical deviation (inner diameter and circularity of metal backing in a defined measurement plane) from design specifications under loading conditions
3.2
spherical socket deformation
articulating surface deformation
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 1a))
Note 1: In case of doubt, the polar axis can be defined as a straight line perpendicular to the plane spanning around the contact zone of the acetabular component to the cortical bone, and passing through the centre point of the ball sphere approximating the acetabular component’s outer sphere.
Note 2: In case of an asymmetrically 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 Figures 1b) and 1c)).
Note 3: In case the frontal face does not contain any part perpendicular to the component axis, the frontal face reference plane can be located at that level perpendicular to the polar axis at the approximated middle between the highest and the lowest point of the frontal face (see Figure 1d)).
Note: Marked (shaded) areas 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 and fully seated intraoperatively
Example: For symmetrically shaped acetabular components, Figure 1a), the loading plane will usually be located close to the frontal face reference plane.
3.5
measurement plane
plane, parallel to the 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: The sensitivity of the deformation measurement decreases with increasing distance of the measurement plane from the front face reference plane and with decreasing distance of the measurement plane to the top of the cup.
Note 2: 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 capturing 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-point 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 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 affect 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 articular 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 cups up to a diameter of 100 mm and a height of 50 mm.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Apparatus
6 Procedure
7 Report
Bibliography
CS 11.040.40
C 35
YY
中華人民共和國(guó)醫(yī)藥行業(yè)標(biāo)準(zhǔn)
外科植入物 部分和全髖關(guān)節(jié)假體
第12部分：髖臼杯形變測(cè)試方法
Implants for surgery—Partial and total hip joint prostheses—
Part 12：Deformation test method for acetabular shells
(ISO 7206-12：2016，MOD)
2020-06-30發(fā)布 2021-06-01實(shí)施
國(guó)家藥品監(jiān)督管理局 發(fā)布
前言
YY／T 0809《外科植入物 部分和全髖關(guān)節(jié)假體》預(yù)計(jì)分為以下幾個(gè)部分：
——第1部分：分類(lèi)和尺寸標(biāo)注；
——第2部分：金屬、陶瓷及塑料關(guān)節(jié)面；
——第3部分：(預(yù)留)；
——第4部分：帶柄股骨部件疲勞性能試驗(yàn)和性能要求；
——第5部分：(預(yù)留)；
——第6部分：帶柄股骨部件頸部疲勞性能試驗(yàn)和性能要求；
——第7部分：(預(yù)留)；
——第8部分：有扭矩作用的帶柄股骨部件疲勞性能；
——第9部分：(預(yù)留)；
——第10部分：組合式股骨頭抗靜載力測(cè)定；
——第11部分：
——第12部分：髖臼杯形變測(cè)試方法；
——第13部分：帶柄股骨部件頭部固定抗扭轉(zhuǎn)力矩的測(cè)定。
本部分為YY／T 0809的第12部分。
本部分按照GB／T 1．1—2009給出的規(guī)則起草。
本部分使用重新起草法修改采用ISO 7206-12：2016《外科植入物 部分和全髖關(guān)節(jié)假體 第12部分：髖臼杯形變測(cè)試方法》。
本部分與ISO 7206-12：201 6相比，存在如下技術(shù)差異：
——關(guān)于規(guī)范性引用文件，本部分做了具有技術(shù)性差異的調(diào)整，以適應(yīng)我國(guó)的技術(shù)條件，調(diào)整的情況集中反映在第2章“規(guī)范性引用文件”中，具體調(diào)整如下：
· 用GB／T 1184代替ISO 2768-2，并調(diào)整至參考文獻(xiàn)中；
· 用等同采用國(guó)際標(biāo)準(zhǔn)的GB／T 12417．2代替ISO 21534；
· 用等同采用國(guó)際標(biāo)準(zhǔn)的YY／T 0809．1代替ISO 7206-1；
· 用修改采用國(guó)際標(biāo)準(zhǔn)的YY／T 0809．2代替ISO 7206-2。
請(qǐng)注意本文件的某些內(nèi)容可能涉及專(zhuān)利。本文件的發(fā)布機(jī)構(gòu)不承擔(dān)識(shí)別這些專(zhuān)利的責(zé)任。
本部分由國(guó)家藥品監(jiān)督管理局提出。
本部分由全國(guó)外科植人物和矯形器械標(biāo)準(zhǔn)化技術(shù)委員會(huì)骨科植入物分技術(shù)委員會(huì)(SAC／TC 110／SC 1)歸口。
外科植入物 部分和全髖關(guān)節(jié)假體
第12部分：髖臼杯形變測(cè)試方法
1 范圍
YY／T 0809的本部分規(guī)定了在特定的實(shí)驗(yàn)室條件下，測(cè)量用于全髖關(guān)節(jié)置換的壓配式髖臼部件短期形變的試驗(yàn)方法，也規(guī)定了測(cè)試條件，考慮了影響測(cè)試部件的重要參數(shù)，并且描述了試驗(yàn)樣品的安裝方法。此外，還規(guī)定了測(cè)試壓配式髖臼部件的試驗(yàn)參數(shù)。
本試驗(yàn)方法適用于在相似試驗(yàn)條件下對(duì)用于全髖關(guān)節(jié)置換的不同髖臼部件的設(shè)計(jì)和材料進(jìn)行對(duì)比、評(píng)估。
髖臼部件在體內(nèi)的受力情況一般不同于本試驗(yàn)方法規(guī)定的受力情況。本試驗(yàn)得到的結(jié)果不能直接用于預(yù)測(cè)髖臼部件在體內(nèi)的性能。
本部分不包括試驗(yàn)樣品的檢查方法。
2 規(guī)范性引用文件
下列文件對(duì)于本文件的應(yīng)用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。
GB／T 1241 7．2 無(wú)源外科植入物 骨接合與關(guān)節(jié)置換植入物 第2部分：關(guān)節(jié)置換植入物特殊要求(GB／T 12417．2—2008，ISO 21534：2002，IDT)
YY／T 0809．1 外科植入物 部分和全髖關(guān)節(jié)假體 第1部分：分類(lèi)和尺寸標(biāo)注(YY／T 0809．1 2010，ISO 7206-1：2008，IDT)
YY／T 0809．2 外科植入物 部分和全髖關(guān)節(jié)假體 第2部分：金屬、陶瓷及塑料關(guān)節(jié)面(YY／T 0809．2 2010，ISO 7206-2：1996，MOD)
3 術(shù)語(yǔ)和定義
YY／T 0809．1、YY／T 0809．2和GB／T 12417．2界定的以及下列術(shù)語(yǔ)和定義適用于本文件。
3．1
金屬杯形變 metal backing deformation
在加載條件下，金屬杯的內(nèi)徑和網(wǎng)度在規(guī)定的測(cè)量平面內(nèi)與設(shè)計(jì)尺寸的幾何偏差。
3．2
內(nèi)球面形變 spherical socketde formation
關(guān)節(jié)面形變 articulating surface deformation
在加載條件下，直徑和網(wǎng)度在規(guī)定的測(cè)量平面內(nèi)與設(shè)計(jì)尺寸的幾何偏差。
3．3
前參考平面 frontal face reference plane
垂直于髖臼部件極軸的平面，通常為髖臼部件的前平面[見(jiàn)圖1a)]
注1：如有異議，極軸可定義為與髖臼部件和皮質(zhì)骨接觸區(qū)域的橫跨面垂直，并通過(guò)髖臼部件外球球心的直線。
注2：如髖臼部件前平面形狀不對(duì)稱(chēng)，比如解剖型的髖臼部件，前參考平面可定義為垂直于髖臼部件極軸且包含最大前平面的平面[見(jiàn)圖1b)和圖1c)]。
注3：如髖臼部件前平面無(wú)垂直于髖臼部件極軸的區(qū)域，前參考平面可定義為前平面最高點(diǎn)和最低點(diǎn)中間位置的一個(gè)垂直于極軸的平面[見(jiàn)圖1d)]。
注：髖臼前平面標(biāo)注區(qū)域(陰影部分)位于參考平面內(nèi)。
圖1 髖臼部件的前參考平面
3．4
加載平面 Loading plane
平行于前參考平面，位于在術(shù)中正確放置髖臼杯后髖臼杯與皮質(zhì)骨接觸區(qū)域的一個(gè)平面。
示例：對(duì)于對(duì)稱(chēng)的髖臼部件[如圖1a)]，加載平面通常位于接近前參考平面的位置。
3．5
測(cè)量平面 Measurement plane
平行于前參考平面，距前參考平面一定距離但盡可能地接近的一個(gè)平面。
注1：形變測(cè)量的靈敏度隨著測(cè)量平面和前參考平面之間距離的增加而降低，隨著測(cè)量平面與髖臼杯頂端距離的減小而降低。
注2：可從測(cè)量平面內(nèi)獲取測(cè)量點(diǎn)來(lái)測(cè)定試驗(yàn)樣品的內(nèi)徑。因此，定義測(cè)量平面時(shí)應(yīng)保證測(cè)量點(diǎn)的獲取不會(huì)受到試驗(yàn)樣品任何設(shè)計(jì)特征(如孔或缺口)的干擾。測(cè)量點(diǎn)可直接從試驗(yàn)樣品上獲取，不可從加載裝置上獲取。
4 試驗(yàn)原理
在試驗(yàn)樣品直徑兩端，施加相對(duì)方向的兩點(diǎn)載荷。測(cè)定短期形變時(shí)，在規(guī)定的測(cè)量平面內(nèi)，測(cè)量試驗(yàn)樣品加載前、加載時(shí)和卸載后在加載方向上的直徑。此后，繞產(chǎn)品本身旋轉(zhuǎn)2次，每次旋轉(zhuǎn)120°，重復(fù)以上形變測(cè)定步驟，以考慮非對(duì)稱(chēng)設(shè)計(jì)(如翼凸、孔等)的影響。
組配式金屬髖臼部件可能會(huì)發(fā)生形變并影響髖臼內(nèi)襯的裝配。而金屬髖臼杯與髖臼內(nèi)襯的組配件也可能發(fā)生形變并影響摩擦性能。所以應(yīng)分為兩步測(cè)試此類(lèi)部件：第一步，僅測(cè)試金屬杯。第二步，測(cè)試已裝配好髖臼內(nèi)襯的金屬杯。
整體式髖臼杯部件的壓配固定可能導(dǎo)致關(guān)節(jié)面的形變，進(jìn)而影響摩擦性能。此類(lèi)部件應(yīng)一步完成測(cè)試。
5 儀器設(shè)備
5．1 加載裝置
加載裝置應(yīng)該具備以下功能：
a) 當(dāng)試樣加載時(shí)，不會(huì)出現(xiàn)可見(jiàn)的和不可逆的變形；
b) 應(yīng)能沿規(guī)定的機(jī)械軸線對(duì)試樣進(jìn)行重復(fù)加載和卸載，并應(yīng)能分別測(cè)量載荷和位移；
c) 應(yīng)能對(duì)最大直徑100 mm、高度50 mm的髖臼杯加載。
圖2 對(duì)髖臼杯或髖臼杯系統(tǒng)施加兩點(diǎn)載荷的加載裝置示例
圖2所示為一種加載裝置，該裝置在參考文獻(xiàn)[1]和參考文獻(xiàn)[12]中均有描述。如圖3所示，加載裝置有兩個(gè)固定在兩條平行導(dǎo)軌兩端的橫梁和兩個(gè)通用的可沿導(dǎo)軌滑動(dòng)的橫梁。載荷通過(guò)載荷調(diào)節(jié)螺栓施加到一個(gè)可移動(dòng)橫梁，并通過(guò)螺旋彈簧傳導(dǎo)至第二個(gè)可移動(dòng)橫梁。
注：螺旋彈簧降低了裝置的剛度，使得加載時(shí)能獲得較大的載荷容差以克服加載過(guò)程中微小位移對(duì)實(shí)驗(yàn)加載的影響，因?yàn)闈撛诘妮d荷偏籌取決于位移與系統(tǒng)剛度系數(shù)的乘積。
說(shuō)明：
1——導(dǎo)軌； 7——載荷調(diào)節(jié)螺栓；
2，3——固定橫梁； 8——載荷傳感器；
4，5——可移動(dòng)橫梁； 9——夾持／加載平面。
6——螺旋彈簧；
圖3 加載裝置原理圖
加載過(guò)程中，夾持樣品的夾爪應(yīng)具有平整的夾持平面(平整度參見(jiàn)GB／T 1184)，避免樣品在加載或測(cè)量過(guò)程中因傾斜或滑動(dòng)產(chǎn)生側(cè)向力。
某些髖臼部件的設(shè)計(jì)包括了一些具有特定目的設(shè)計(jì)元素，如復(fù)雜的翻修手術(shù)或病人的特殊需求，具體例如邊緣錨定，符合解剖形態(tài)的邊緣等。如果測(cè)試此類(lèi)髖臼部件，應(yīng)設(shè)計(jì)和使用合適的夾爪用于固定和加載試樣。
夾持面的寬度應(yīng)不低于測(cè)試樣品前參照面外徑的20％，這樣在試驗(yàn)前可將試樣接觸點(diǎn)通過(guò)手動(dòng)調(diào)整至夾持面的中心，而無(wú)需附加對(duì)中裝置或工具。如果使用其他對(duì)中裝置或工具，應(yīng)確保兩點(diǎn)載荷和試樣的變形不會(huì)受到限制。
載荷傳感器應(yīng)能測(cè)量軸向壓力且不確定度為1％。
5．2 試樣選擇
應(yīng)隨機(jī)選取被確定為最差情況型號(hào)的髖臼部件作為試樣，其應(yīng)能代表產(chǎn)品的生產(chǎn)制造，并與最終產(chǎn)品具有相同的幾何結(jié)構(gòu)，使用相同的材料規(guī)范和加工工藝。
注：對(duì)于組合式的髖臼部件，對(duì)于第一步試驗(yàn)(金屬杯的變形)和第二步試驗(yàn)(髖臼部件關(guān)節(jié)面的變形)最差情況型號(hào)可能會(huì)不一樣。
如果組合式髖臼部件使用了不同關(guān)節(jié)面材料，則應(yīng)評(píng)估所有內(nèi)襯的關(guān)節(jié)面材料和尺寸以確定其最差情況。同時(shí)也應(yīng)考慮設(shè)計(jì)特征，例如不對(duì)稱(chēng)排列的螺釘孔。
6 試驗(yàn)步驟
a) 加載之前，用一種可行的測(cè)量裝置在各個(gè)預(yù)期的加載方向測(cè)量試樣內(nèi)徑D0[mm]。應(yīng)測(cè)量位于測(cè)量平面上臼窩的內(nèi)徑，測(cè)量不確定度應(yīng)小于5 μm。
此外，在同一個(gè)測(cè)量平面內(nèi)可在其他位置測(cè)量直徑，比如，在垂直于加載方向進(jìn)行測(cè)量，以獲取試樣整體變形行為的補(bǔ)充數(shù)據(jù)。
b) 將試樣置于試驗(yàn)裝置上，平穩(wěn)地旋轉(zhuǎn)載荷調(diào)節(jié)螺栓以施加并保持(1.00±0.01)kN的軸向載荷。要避免不穩(wěn)定的加載。試樣與試驗(yàn)裝置加載面的接觸點(diǎn)應(yīng)位于加載平面內(nèi)。
c) 在a)中所述的同一測(cè)量平面內(nèi)，用同一測(cè)量裝置在加載方向測(cè)量試樣的直徑D1(mm)。髖臼杯的變形等于D0—D1。
d) 卸載。
e) 按c)中所述的測(cè)量方向，使用同一測(cè)量裝置再次測(cè)量直徑D0’[mm]。如果測(cè)得與a)中所得的初始直徑的殘差，D0’—D0，大于測(cè)量設(shè)備的不確定度，且測(cè)得大于c)中得到的變形的2％[(D0’—D0)／(D0—D0)＞0.02]，說(shuō)明發(fā)生了塑性變形。在這種情況下，應(yīng)停止測(cè)試該試樣，使用下一個(gè)試樣從a)開(kāi)始進(jìn)行試驗(yàn)。
f) 以部件極軸作為旋轉(zhuǎn)中心，相對(duì)之前的位置把杯旋轉(zhuǎn)120°，重復(fù)b)～e)步驟。仍以部件極軸作為旋轉(zhuǎn)中心，相對(duì)之前的位置把杯再次旋轉(zhuǎn)120°，重復(fù)b)～e)步驟。然后測(cè)試下一試樣。
試驗(yàn)條件：組裝和測(cè)量應(yīng)在一致的實(shí)驗(yàn)室條件下進(jìn)行。
試驗(yàn)樣本數(shù)量至少為3件。對(duì)于不對(duì)稱(chēng)的樣品，應(yīng)確定參照方位。試驗(yàn)開(kāi)始前相對(duì)該方位繞極軸的旋轉(zhuǎn)角在不同試樣問(wèn)應(yīng)變化。
除了僅在加載方向測(cè)量樣品直徑，也可以通過(guò)在適當(dāng)?shù)臏y(cè)量平面內(nèi)評(píng)估試樣直徑和網(wǎng)度的差異來(lái)測(cè)定其變形。
某些罕見(jiàn)的髖臼部件設(shè)計(jì)為壓配式整杯，它們由塑料制成，盡管其臨床效果頗佳，但仍不能承受本標(biāo)準(zhǔn)規(guī)定的不產(chǎn)生不可逆損壞的載荷條件。在這種情況下，可以適當(dāng)降低載荷。該類(lèi)新設(shè)計(jì)髖臼杯系統(tǒng)與已有臨床產(chǎn)品的對(duì)比也應(yīng)使用小載荷的測(cè)試結(jié)果。
7 報(bào)告
試驗(yàn)報(bào)告應(yīng)包含以下信息：
a) 引用YY／T 0809本部分的內(nèi)容；
b) 髖臼杯所有部件的特征及描述，應(yīng)與委托檢測(cè)試樣的一方所陳述的一致，以及制造商名稱(chēng)和所列參考文獻(xiàn)；
c) 每種最差情況的設(shè)計(jì)、尺寸、材料組合(如適用)的髖臼部件(如杯、內(nèi)襯)的尺寸及公差；
d) 與髖臼部件設(shè)計(jì)規(guī)范的偏離；
e) 試驗(yàn)裝置的材料和剛度，如螺旋彈簧的材料和剛度；
f) 針對(duì)非對(duì)稱(chēng)杯邊緣設(shè)計(jì)，如圖1b)～圖1d)所示，描述在裝置中加載時(shí)臼杯的方位，以給出臼杯和加載平面的接觸信息，如拍攝照片；
g) 針對(duì)非對(duì)稱(chēng)杯邊緣設(shè)計(jì)，如圖1b)～圖1d)所示，描述如何定義極軸；
h) 針對(duì)非對(duì)稱(chēng)杯邊緣設(shè)計(jì)，如圖1b)～圖1d)所示，描述如何針對(duì)試樣設(shè)計(jì)定義前參照平面；
i) 從測(cè)量平面到前參照平面的距離，以及測(cè)量平面相對(duì)于前參照平面(遠(yuǎn)端／近端)如何定位；
j) 加載時(shí)，對(duì)應(yīng)于每一個(gè)最差情況的結(jié)構(gòu)(如杯、杯／內(nèi)襯組合)、設(shè)計(jì)、尺寸和材料組合所測(cè)試的范圍和平均變形(標(biāo)準(zhǔn)偏差)(直徑，其他測(cè)量結(jié)果)；
k) 卸載后，對(duì)應(yīng)于每一個(gè)最差情況的結(jié)構(gòu)(如杯、杯／內(nèi)襯組合)、設(shè)計(jì)、尺寸和材料組合所測(cè)試的范圍和平均塑性變形(標(biāo)準(zhǔn)偏差)(直徑，其他測(cè)量結(jié)果)；
l) 測(cè)量裝置的規(guī)范(直徑測(cè)量)；
m) 任何因測(cè)試方法造成的偏差。
參考文獻(xiàn)
[1] GB／T 1184 形狀和位置公差 未注公差值(GB／T 1184—1996，ISO 2768-2：1989，EQV)
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[6] GrimesJ．B．Reclassification of metal-metal bearings based on operational clearance．56th Ann Meet ORS (Poster 2277)，March 6-9，New Orleans，2010
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[8] BishopN．，＆ MorlockM．M．The risk of acetabular cup turn out due to joint friction moments．56th Ann Meet ORS (Poster 2025)，March 6-9，New Orleans，2010
[9] JinZ．M．，MeakinsS．，MorlockM．M．，ParsonsP．，HardakerC．，F(xiàn)lettM．，IsaacG．
Deformation of press-fitted metallic resurfacing cups—Part 1：Experimental simulation．Proc．Inst．Mech Eng．H．2006，220(2) pp．299-309
[10] FritscheA．，BialekK．，MittelmeierW．，SimnacherM．，F(xiàn)ethkeK．，WreeA．，BaderR．Experimental investigations of the insertion and deformation behaviour of press-fit and threaded cupS for total hip replacement．J．Orthop．Sci．2008，13(3)pp．240-247
[11] Hogg M．C．，& GilliesR．M．Impaction of a press-fit acetabular cup using a dynamic finite element
[12] Hogg M．C．，＆ Gillies R．M．Impaction of a typical press-fit modular acetabular cup using a dynamic finite element method．56th Ann Meet ORS(Poster 2105)，March 6-9，New Orleans，2010
[13] HothanA．，HuberG．，WeissC．，HoffmannN．，MorlockM．M．Deformation characteristics and eigenfrequencies of press-fit acetabular cups．Clin．Biomech．(Bristol，Avon)．2011，26(1) pp．46-51
