摘要
1.1 This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).1.2 The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.1.3 This guide may be used in the selection of appropriate test methods for the generation of an original equipment manufacture (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.1.4 This guide is intended to be utilized in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) utilized in the fabrication of the scaffold, such as described in Guide F 2027.1.5 This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold. A determination of the suitability of a particular starting material and/or finished scaffold structure to a specific cell type and/or tissue engineering application is essential, but will require additionalin vitroand/orin vivoevaluations considered to be outside the scope of this guide.1.6This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use. ====== Significance And Use ======Scaffolds potentially may be metallic, ceramic, polymeric, natural, or composite materials. Scaffolds are usually porous to some degree, but may be solid. Scaffolds can range from mechanically rigid to gelatinous and can be either absorbable/degradable or nonresorbable/nondegradable. The scaffold may or may not have a surface treatment. Because of this large breadth of possible starting materials and scaffold constructions, this guide cannot be considered as exhaustive in its listing of potentially applicable tests. A voluntary guidance for the development of tissue-engineered products can be found in Omstead, et al(1). Guide F 2027contains a listing of potentially applicable test methods specific to various starting materials.Each TEMP scaffold product is unique and may require testing not within the scope of this guide or other guidance documents. Users of this guide are encouraged to examine the references listed herein and pertinent FDA or other regulatory guidelines or practices, and conduct a literature search to identify other procedures particularly pertinent for evaluation of their specific scaffold material(2,3,4). It is the ultimate responsibility of the TEMP scaffold designer to determine the appropriate testing, whether or not it is described in this guide.A listing of potentially applicable tests for characterizing and analyzing the materials utilized to fabricate the scaffold may be found in Guide F 2027. However, conformance of a raw material to this and/or any other compendial standard(s) does not, in itself, ensure that the selected material is suitable or that the provided quality is adequate to meet the needs of a particular application. Thus, other characterization procedures may also be relevant and not covered by this guide.The following provides a listing of links to U.S. Food&Drug Administration (FDA)—Center for Devices&Radiologic Health (CDRH) web sites that may potentially contain additional guidance relevant to biomaterial scaffolds covered within this document.Recognized FDA-CDRH Consensus Standards Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfmThis database provides a resource for locating FDA recognized consensus standards for medical products.FDA-CDRH Good Guidance Practice (GGP) Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfmThis database provides a resource for locating non-binding FDA guidance documents intended for CDRH staff, regulated industry and the public that relate to the processing, content, and evaluation of regulatory submissions, the design, production, manufacturing, and testing of regulated products, and FDA inspection and enforcement procedures.A document within this database possessing content that warrants particular consideration for its potential applicability for tissue engineering scaffolds isGuidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final.FDA-CDRH Premarket Approval (PMA) Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfmFDA-CDRH 510(k) (Premarket Notification) Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
1.1本指南是用于开发和制造组织工程医疗产品（TEMP）的生物材料支架的成分和结构方面表征的现有测试方法的资源。1.2本文包含的测试方法指导了支架结构的整体物理、化学、机械和表面特性的表征。这些特性对于TEMP的成功可能很重要，尤其是当它们影响细胞保留、活性和组织、生物活性剂的传递或最终产品内的生物相容性和生物活性时。1.3本指南可用于选择适当的测试方法，以生成原始设备制造商（OEM）规范。本指南也可用于表征成品医疗产品的支架组件。1.4本指南旨在与支架制造中使用的任何原材料或起始材料的适当表征和评估结合使用，如指南F 2027中所述.1.5本指南介绍了含或不含生物活性剂或生物活性的天然、合成或组合支架材料。本指南不涉及与支架结合使用的任何生物分子、细胞、药物或生物活性剂的表征或释放曲线。确定特定起始材料和/或成品支架结构对特定细胞类型和/或组织工程应用的适用性至关重要，但需要额外的体外和/或体内被认为不在本指南范围内的评估。1.6本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管要求的适用性。====意义和用途======支架可能是金属、陶瓷、聚合物、天然或复合材料。支架通常具有一定程度的多孔性，但也可能是固体。支架可以是机械刚性的，也可以是凝胶状的，可以是可吸收/可降解的，也可以是不可吸收/不可降解的。脚手架可以进行表面处理，也可以不进行表面处理。由于可能的起始材料和脚手架结构如此广泛，本指南在其潜在适用测试列表中不能被视为详尽无遗。组织工程产品开发的自愿指南见Omstead等人(1). 指南F 2027包含针对各种起始材料的潜在适用测试方法列表。每个临时脚手架产品都是独特的，可能需要进行不在本指南或其他指导文件范围内的测试。鼓励本指南的用户检查此处列出的参考文献和相关的FDA或其他监管指南或实践，并进行文献搜索，以确定与评估其特定支架材料特别相关的其他程序(2,3,4). 临时脚手架设计师的最终责任是确定适当的测试，无论本指南中是否有描述。指南F 2027中列出了用于表征和分析用于制造脚手架的材料的潜在适用测试. 然而，原材料符合本标准和/或任何其他药典标准本身并不能确保所选材料合适或所提供的质量足以满足特定应用的需要。因此，其他表征程序也可能是相关的，本指南未涵盖。以下列出了美国食品的链接&美国药品监督管理局（FDA）—设备中心&放射学健康（CDRH）网站，可能包含与本文件涵盖的生物材料支架相关的其他指南。公认的FDA-CDRH共识标准数据库:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm该数据库为查找FDA认可的医疗产品共识标准提供了资源。FDA-CDRH良好指导实践（GGP）数据库:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm该数据库提供了一个资源，用于查找针对CDRH员工、受监管行业和公众的非约束性FDA指导文件，这些文件涉及监管提交文件的处理、内容和评估、受监管产品的设计、生产、制造和测试，以及FDA检查和执行程序。该数据库中的一份文件包含的内容需要特别考虑其对组织工程支架的潜在适用性外科网片上市前通知申请准备指南；最终的.FDA-CDRH上市前批准（PMA）数据库:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfmFDA-CDRH 510（k）（上市前通知）数据库:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
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