BIOMOMENTUM力學(xué)試驗(yàn)機(jī)-組織工程醫(yī)療產(chǎn)品（TEMP）的標(biāo)準(zhǔn)分類

ASTM F2211 - Standard Classification for Tissue Engineered Medical Products (TEMPs)

ASTM International, West Conshohocken, PA, 2013

Significance and Use

4.1 This classification outlines aspects of TEMPs which includes their individual components.
4.2 The categories outlined in this classification are intended to list, identify, and group the areas pertinent to Tissue Engineered Medical Products. This classification will be used by the Tissue Engineered Medical Products subcommittees for the organization of the development of standards for the field of tissue engineering, TEMPs, and protocols for their use. The development of products from the new tissue engineering technologies necessitates creation and implementation of new standards.
4.3 Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. The degree of overall risk for any given TEMP is reflected by the number and types of tests required to demonstrate product safety and efficacy.

意義和用途

4.1此分類概述了TEMP的各個(gè)方面，包括其各個(gè)組成部分。
4.2此分類中概述的類別旨在列出，識(shí)別和分組與組織工程醫(yī)療產(chǎn)品有關(guān)的區(qū)域。組織工程醫(yī)療產(chǎn)品小組委員會(huì)將使用此分類來組織組織工程領(lǐng)域的標(biāo)準(zhǔn)，TEMP及其使用協(xié)議的開發(fā)。利用新的組織工程技術(shù)開發(fā)產(chǎn)品需要?jiǎng)?chuàng)建和實(shí)施新的標(biāo)準(zhǔn)。
4.3由于在TEMP中使用的組件之間可能發(fā)生交互作用，因此需要新的標(biāo)準(zhǔn)說明，測試方法和實(shí)踐來幫助評(píng)估這些交互作用。任何給定的TEMP的總體風(fēng)險(xiǎn)程度均通過證明產(chǎn)品安全性和有效性所需的測試數(shù)量和類型來反映。

biomomentum多軸機(jī)械測試儀Mach-1測試意義及適用范圍：

材料力學(xué)性能可以應(yīng)用到生產(chǎn)的任何階段，從測試原材料質(zhì)量直到檢查制成品的耐用性。 測試可對(duì)廣泛多樣的生物樣品、材料和產(chǎn)品進(jìn)行，包括軟組織、軟骨組織、皮膚組織、凝膠組織、高分子材料、生物產(chǎn)品、醫(yī)學(xué)鑒定和水凝膠等。力學(xué)性能測試可幫助企業(yè)向客戶證明其產(chǎn)品的力學(xué)性能、穩(wěn)定性和安性，從而獲得基礎(chǔ)數(shù)據(jù)和競爭勢(shì)。

1、多功能、多軸向，適用樣品范圍廣：

1.1、從骨等硬組織材料到腦組織、眼角膜等極軟的組織材料

1.2、從粗的椎間盤的樣品到極細(xì)的單纖維絲

2、力學(xué)類型測試分析功能齊全：

2.1、模塊化集成壓縮、張力、剪切、摩擦、扭轉(zhuǎn)、穿刺、摩擦和非平面壓痕、3D厚度、3D表面輪廓等各種力學(xué)類型支持,微觀結(jié)構(gòu)表征及動(dòng)態(tài)力學(xué)分析研究

2.2、多物理場耦合加載測試