肩关节假体检测

发布时间：2024-06-21 作者：中析研究所浏览：

YY/T 0963-2014关节置换植入物肩关节假体

本标准规定了关节置换植入物--肩关节假体的术语和定义、分类、材料、设计评价、制造、灭菌、包装、制造商应提供的信息。本标准适用于由关节盂部件和肱骨部件组成并提供功能性关节作用的部分或全肩关节假体。本标准不适用于定制型假体。组合式假体适用于本标准。

YY/T 1634-2018关节置换植入物肩关节假体关节盂松动或分离动态评价试验方法

本标准规定了解剖型肩盂部件在肱骨头向相对的肩盂边缘周期性位移(如，上下或前后)作用下，肩盂部件的摆动量或转动量的测试方法。在动态摆动后通过每个承载边缘反向的拉伸位移量化运动。同时本标准也规定了倒置型关节盂部件在与其配合的肱骨内衬做周期性关节运动时，肩盂部件摆动量或转动量的测量方法。通过加载循环前后的位移量来量化运动。可以用同样的装置测试组合式肩盂部件的锁定机制，如解剖型和倒置型部件的分离。本标准适用于骨水泥固定的整体式或组合式肩盂部件和非骨水泥固定的倒置型肩盂部件。

YY/T 1647-2019关节置换植入物肩关节假体关节盂锁定机制的静态剪切评价试验方法

本标准规定了肩关节假体中组合式关节盂部件的静态剪切分离力的测试方法。组合式关节盂部件应包含一个单独的关节盂内衬和关节盂背衬。关节盂内衬和关节盂背衬可由以下材料任意组合制成：金属合金、聚合材料和复合材料。本标准适用于产品的设计验证和与其他假体的比较。

ASTM F1378-2017肩关节假体的标准规格

1.1x00a0;This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. 1.2x00a0;Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification. 1.3x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. FIG. 1x00a0;Glenosphere Thickness 1.4x00a0;This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F1378-2018肩关节假体标准规范

ASTM F1378-2018e1肩关节假体的标准规范

ABNT NBR 15752-1-2009骨科植入物 - 肩关节假体第1部分-规范

This part of ABNT NBR 15752 establishes specifications for shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components, including those prostheses with modular components.

ABNT NBR 15752-2-2009骨科植入物 - 肩关节假体第2部分-盂松动的动态评价试验方法

This part of ABNT NBR 15752 establishes a method for determining the dynamic glenoid loosening when subject to cyclic loading due a head displacement of an humeral component.

ABNT NBR 15752-3-2009骨科植入物 - 肩关节假体第3部分-测试的模块化组件的静态评价方法盂锁定在剪切机制

This part of ABNT NBR 15752 establishes a method for determining the static shear disassembly forceof modular glenoid components used in shoulder prostheses. It is intended to be used as a design validation and for comparison with other prostheses.

DIN EN ISO 21534-2009非活性外科植入物.关节替代植入物.特殊要求(ISO 21534-2007); 德文版本EN ISO 21534-2009

This International Standard specifies particular requirements for total and partial joint replacement implants,artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this InternationalStandard, artificial ligaments and their associated fixing devices are included in the term \"implant\".It specifies requirements for intended performance, design attributes, materials, design evaluation,manufacturing, sterilization, packaging and information to be supplied by the manufacturer.Some tests required to demonstrate conformance to this International Standard are contained in or referencedin level 3 standards.