肩關(guān)節(jié)假體檢測(cè)

肩關(guān)節(jié)假體檢測(cè)項(xiàng)目報(bào)價(jià)？??解決方案？??檢測(cè)周期？??樣品要求？

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YY/T 0963-2014關(guān)節(jié)置換植入物 肩關(guān)節(jié)假體

本標(biāo)準(zhǔn)規(guī)定了關(guān)節(jié)置換植入物--肩關(guān)節(jié)假體的術(shù)語(yǔ)和定義、分類(lèi)、材料、設(shè)計(jì)評(píng)價(jià)、制造、滅菌、包裝、制造商應(yīng)提供的信息。本標(biāo)準(zhǔn)適用于由關(guān)節(jié)盂部件和肱骨部件組成并提供功能性關(guān)節(jié)作用的部分或全肩關(guān)節(jié)假體。本標(biāo)準(zhǔn)不適用于定制型假體。組合式假體適用于本標(biāo)準(zhǔn)。

YY/T 1634-2018關(guān)節(jié)置換植入物 肩關(guān)節(jié)假體 關(guān)節(jié)盂松動(dòng)或分離動(dòng)態(tài)評(píng)價(jià)試驗(yàn)方法

本標(biāo)準(zhǔn)規(guī)定了解剖型肩盂部件在肱骨頭向相對(duì)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(dòng)量或轉(zhuǎn)動(dòng)量的測(cè)試方法。在動(dòng)態(tài)擺動(dòng)后通過(guò)每個(gè)承載邊緣反向的拉伸位移量化運(yùn)動(dòng)。同時(shí)本標(biāo)準(zhǔn)也規(guī)定了倒置型關(guān)節(jié)盂部件在與其配合的肱骨內(nèi)襯做周期性關(guān)節(jié)運(yùn)動(dòng)時(shí)，肩盂部件擺動(dòng)量或轉(zhuǎn)動(dòng)量的測(cè)量方法。通過(guò)加載循環(huán)前后的位移量來(lái)量化運(yùn)動(dòng)。可以用同樣的裝置測(cè)試組合式肩盂部件的鎖定機(jī)制，如解剖型和倒置型部件的分離。本標(biāo)準(zhǔn)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(guān)節(jié)置換植入物 肩關(guān)節(jié)假體 關(guān)節(jié)盂鎖定機(jī)制的靜態(tài)剪切評(píng)價(jià)試驗(yàn)方法

本標(biāo)準(zhǔn)規(guī)定了肩關(guān)節(jié)假體中組合式關(guān)節(jié)盂部件的靜態(tài)剪切分離力的測(cè)試方法。組合式關(guān)節(jié)盂部件應(yīng)包含一個(gè)單獨(dú)的關(guān)節(jié)盂內(nèi)襯和關(guān)節(jié)盂背襯。關(guān)節(jié)盂內(nèi)襯和關(guān)節(jié)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(fù)合材料。本標(biāo)準(zhǔn)適用于產(chǎn)品的設(shè)計(jì)驗(yàn)證和與其他假體的比較。

ASTM F1378-2017肩關(guān)節(jié)假體的標(biāo)準(zhǔn)規(guī)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(guān)節(jié)假體標(biāo)準(zhǔn)規(guī)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(guān)節(jié)假體的標(biāo)準(zhǔn)規(guī)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(guān)節(jié)假體第1部分-規(guī)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(guān)節(jié)假體第2部分-盂松動(dòng)的動(dòng)態(tài)評(píng)價(jià)試驗(yàn)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(guān)節(jié)假體第3部分-測(cè)試的模塊化組件的靜態(tài)評(píng)價(jià)方法盂鎖定在剪切機(jī)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(guān)節(jié)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.