【国外标准】 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

Scaffolds may be composed of purely mineral or ceramic materials, or they may be composed of a composite material with its main phase being a mineral or ceramic. Scaffolds may be porous or non-porous, mechanically rigid or compliant, and degradable or non-degradable. The scaffold may or may not have undergone a surface treatment.1.1 This guidance document covers the chemical, physical, biological, and mechanical characterization requirements for biocompatible mineral- and ceramic-based scaffolds used solely as device or to manufacture tissue-engineered medical products (TEMPs). In this guide, the pure device or the TEMPs product will be referred to as scaffold.1.2 The test methods contained herein provide guidance on the characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. These properties may be important for the performance of the scaffold, especially if they affect cell behavior, adhesion, proliferation and differentiation. In addition, these properties may affect the delivery of bioactive agents, the biocompatibility and the bioactivity of the final product.1.3 This document may be used as guidance in the selection of test methods for the comprehensive characterization of a raw materials, granules, pre-shaped blocks, or an original equipment manufacture (OEM) specification. This guide may also be used to characterize the scaffold component of a finished medical product.1.4 While a variety of materials can be used to manufacture such scaffolds, the composition of the final scaffold shall contain mineral or ceramic components as its main ingredients.1.5 This guide assumes that the scaffold is homogeneous in nature. Chemical or physical inhomogeneity or mechanical anisotropy of the scaffold shall be declared in the manufacturer’s material and scaffold specification.1.6 This guide addresses neither the biocompatibility of the scaffold, nor the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold.1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.8 This 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 limitations prior to use.