肩關節假體檢測

肩關節假體檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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YY/T 0963-2014關節置換植入物 肩關節假體

本標準規定了關節置換植入物--肩關節假體的術語和定義、分類、材料、設計評價、制造、滅菌、包裝、制造商應提供的信息。本標準適用于由關節盂部件和肱骨部件組成并提供功能性關節作用的部分或全肩關節假體。本標準不適用于定制型假體。組合式假體適用于本標準。

YY/T 1634-2018關節置換植入物 肩關節假體 關節盂松動或分離動態評價試驗方法

本標準規定了解剖型肩盂部件在肱骨頭向相對的肩盂邊緣周期性位移(如，上下或前后)作用下，肩盂部件的擺動量或轉動量的測試方法。在動態擺動后通過每個承載邊緣反向的拉伸位移量化運動。同時本標準也規定了倒置型關節盂部件在與其配合的肱骨內襯做周期性關節運動時，肩盂部件擺動量或轉動量的測量方法。通過加載循環前后的位移量來量化運動。可以用同樣的裝置測試組合式肩盂部件的鎖定機制，如解剖型和倒置型部件的分離。本標準適用于骨水泥固定的整體式或組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關節置換植入物 肩關節假體 關節盂鎖定機制的靜態剪切評價試驗方法

本標準規定了肩關節假體中組合式關節盂部件的靜態剪切分離力的測試方法。組合式關節盂部件應包含一個單獨的關節盂內襯和關節盂背襯。關節盂內襯和關節盂背襯可由以下材料任意組合制成：金屬合金、聚合材料和復合材料。本標準適用于產品的設計驗證和與其他假體的比較。

ASTM F1378-2017肩關節假體的標準規格

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肩關節假體標準規范

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 F1378-2018e1肩關節假體的標準規范

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.

ABNT NBR 15752-1-2009骨科植入物 - 肩關節假體第1部分-規范

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 - 肩關節假體第2部分-盂松動的動態評價試驗方法

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 - 肩關節假體第3部分-測試的模塊化組件的靜態評價方法盂鎖定在剪切機制

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.關節替代植入物.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.