ASTM F3089-14
可聚合的基于胶原蛋白的产品和相关胶原细胞交互作用的特性描述和标准化的标准指南
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
- 标准号
- ASTM F3089-14
- 发布
- 2014年
- 发布单位
- 美国材料与试验协会
- 替代标准
- ASTM F3089-23
- 当前最新
- ASTM F3089-23
- 引用标准
- 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
- 适用范围
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=321 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研究者Morley等人测定了打印后细丝的几何形状如何随时间而变化，因为细胞对胶原蛋白-1施加了牵引力并重塑了基质的结构，通过系统性地改变长丝的厚度和长度，以及其胶原蛋白-1和细胞成分，研究人员就能够全面理解生物材料中细丝的机械性能，尽管该研究仅限于简单的细丝几何形状，但从原则上来讲，其所得到的数据适用于机械模型，而该模型则能描述组织的变形及具有更复杂的细丝几何形状和模式的组织。 ...
转录组和蛋白组相互印证，V型胶原蛋白或是治疗心肌梗死的救星！
做蛋白组学· 找吉凯吉凯基因凭借多年在靶标筛选及验证服务领域的技术积累，建立的标准化 、工程化 、系统化的GRP平台，为中国研究型医生提供科研服务，加快科研成果转化。...
DHC等品牌胶原蛋白液涉嫌违规宣传实际为普通饮料
■记者调查 Lumi胶原蛋白系列产品 宣传：“7天告别粗糙毛孔” Lumi网上商城对该产品的描述是胶原蛋白集补水、抗皱、紧肤、美白、祛暗黄、收缩毛孔、美发美甲、抗氧化等功效于一体，适用于各种肤质，补充胶原蛋白肽可根本性解决各年龄段皮肤问题，令肌肤宛若新生。并有黑色素降76%，7天告别粗糙毛孔等大字符宣传语。 ...
3D细胞培养技术
ECM的主要组分是层粘连蛋白、IV型胶原、蛋白多糖硫酸乙酰肝素和巢蛋白。这种水凝胶聚合物可通过20-40°C热激活，凝胶化过程也是可逆的(蛋白质浓度:8–12mg/ml)。 MaxGel™ 胞外基质：MaxGel人细胞外基质源于体外培养的细胞基底膜，含有可预测的低水平内源生长因子，更适合需要更明确和特征再造BME的应用，终可降低实验的可变性。...
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