ASTM F2150-2007
组织工程医疗产品中使用的生物材料支架的表征和试验用标准指南
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
ASTM F2150-2007 中，可能用到以下耗材
- 适用范围
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 2027
contains 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 x0026; Drug Administration (FDA)x2014;Center for Devices x0026; 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.cfm
This 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.cfm
This 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 is Guidance 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.cfm
FDA-CDRH 510(k) (Premarket Notification) Database:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
1.1 This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaf......