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Significance and Use
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
C373 Test Method for Water Absorption, Bulk Density, Apparent Porosity, and Apparent Specific Gravity of Fired Whiteware Products
C693 Test Method for Density of Glass by Buoyancy
C729 Test Method for Density of Glass by the Sink-Float Comparator
C830 Test Methods for Apparent Porosity, Liquid Absorption, Apparent Specific Gravity, and Bulk Density of Refractory Shapes by Vacuum Pressure
C1198 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by Sonic Resonance
C1274 Test Method for Advanced Ceramic Specific Surface Area by Physical Adsorption
C1424 Test Method for Monotonic Compressive Strength of Advanced Ceramics at Ambient Temperature
D695 Test Method for Compressive Properties of Rigid Plastics
D1621 Test Method for Compressive Properties of Rigid Cellular Plastics
D4404 Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry
D6226 Test Method for Open Cell Content of Rigid Cellular Plastics
D6420 Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry
E128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E456 Terminology Relating to Quality and Statistics
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E996 Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
E1078 Guide for Specimen Preparation and Mounting in Surface Analysis
E1131 Test Method for Compositional Analysis by Thermogravimetry
E1252 Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
E1269 Test Method for Determining Specific Heat Capacity by Differential Scanning Calorimetry
E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
E1504 Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
E1635 Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
E1642 Practice for General Techniques of Gas Chromatography Infrared (GC/IR) Analysis
E1829 Guide for Handling Specimens Prior to Surface Analysis
E1876 Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio by Impulse Excitation of Vibration
E2070 Test Method for Kinetic Parameters by Differential Scanning Calorimetry Using Isothermal Methods
E2253 Test Method for Temperature and Enthalpy Measurement Validation of Differential Scanning Calorimeters
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
F1634 Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
F2024 Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2809 Terminology Relating to Medical and Surgical Materials and Devices
ISO DocumentsISO9001 Quality Management Systems--Requirements
ICS Number Code 11.100.99 (Other standards related to laboratory medicine)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)