ASTM F3089-14
可聚合的基于膠原蛋白的產品和相關膠原細胞交互作用的特性描述和標準化的標準指南

Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

被代替

標準號

ASTM F3089-14

發布

2014年

發布單位

美國材料與試驗協會

替代標準

ASTM F3089-23

當前最新

ASTM F3089-23

 

 

引用標準

ASTM E1298 ASTM F1251 ASTM F1439 ASTM F1903 ASTM F1904 ASTM F1905 ASTM F1906 ASTM F1983 ASTM F2148 ASTM F619 ASTM F720 ASTM F748 ASTM F749 ASTM F756 ASTM F763 ASTM F813 ASTM F895 ASTM F981 ISO 14971

適用范圍

4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (a) collagen polymers as a starting material for surgical implants, substrates for tissue-engineered medical products (TEMPs), vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing; and (b) self-assembled collagen-based materials produced with collagen polymer formulations. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate collagen polymer starting material as well as associated self-assembled collagen-based products for a specific use. Not all tests or parameters are applicable to all uses of collagen.

4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound and hemostatic dressings, surgical implants or injectables, hybrid medical devices, tissue-engineered medical products (TEMPs), injectable or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in-vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of the collagen polymers and associated self-assembled collagen-based materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any research or medical application.

4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of collagen polymer, impurities profile, and comprehensive chemical, physical, and biological characterization and testing.

4.4 The following documents or other relevant guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of devices, biologics, drugs, and combination products should be considered when determining if the collagen supplied satisfies requirements for use in medical and research products, including TEMPs, therapeutic delivery vehicles, and 3D in-vitro tissue systems:

FDA CFR:

21 CFR 3: Product Jurisdiction:

8199;8199;8199;http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ 8199;8199;8199;8199;CFRSearch.cfm?CFRPart=3

21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:

8199;8199;8199;http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ 8199;8199;8199;8199;CFRSearch.cfm?CFRPart=58

如何利用3D打印技術打印出成熟形態的機體組織器官？ 研究者Morley等人測定了打印后細絲的幾何形狀如何隨時間而變化，因為細胞對膠原蛋白-1施加了牽引力并重塑了基質的結構，通過系統性地改變長絲的厚度和長度，以及其膠原蛋白-1和細胞成分，研究人員就能夠全面理解生物材料中細絲的機械性能，盡管該研究僅限于簡單的細絲幾何形狀，但從原則上來講，其所得到的數據適用于機械模型，而該模型則能描述組織的變形及具有更復雜的細絲幾何形狀和模式的組織。　　... 轉錄組和蛋白組相互印證，V型膠原蛋白或是治療心肌梗死的救星！ 做蛋白組學· 找吉凱吉凱基因憑借多年在靶標篩選及驗證服務領域的技術積累，建立的標準化 、工程化 、系統化的GRP平臺，為中國研究型醫生提供科研服務，加快科研成果轉化。... DHC等品牌膠原蛋白液涉嫌違規宣傳實際為普通飲料 ■記者調查 　　Lumi膠原蛋白系列產品?宣傳：“7天告別粗糙毛孔” 　　Lumi網上商城對該產品的描述是膠原蛋白集補水、抗皺、緊膚、美白、祛暗黃、收縮毛孔、美發美甲、抗氧化等功效于一體，適用于各種膚質，補充膠原蛋白肽可根本性解決各年齡段皮膚問題，令肌膚宛若新生。并有黑色素降76%，7天告別粗糙毛孔等大字符宣傳語。 　　... 3D細胞培養技術 ECM的主要組分是層粘連蛋白、IV型膠原、蛋白多糖硫酸乙酰肝素和巢蛋白。這種水凝膠聚合物可通過20-40°C熱激活，凝膠化過程也是可逆的(蛋白質濃度:8–12mg/ml)。?????? MaxGel? 胞外基質：MaxGel人細胞外基質源于體外培養的細胞基底膜，含有可預測的低水平內源生長因子，更適合需要更明確和特征再造BME的應用，終可降低實驗的可變性。... ASTM F3089-14 中可能用到的儀器設備 酶標儀 誰引用了ASTM F3089-14 更多引用 ASTM F3510-21 組織工程醫療產品用纖維結構特征的標準指南 Copyright ?2007-2022 ANTPEDIA, All Rights Reserved 京ICP備07018254號 京公網安備1101085018 電信與信息服務業務經營許可證：京ICP證110310號

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