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ASTM F2883-11

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Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

Automaticky preložený názov:

Štandardné Príručka pre charakterizáciu keramické a minerálne látky lešenia používa pre tkanivového inžinierstva liečiv (brigádnikov) a ako prostriedok pre chirurgický implantát aplikácie

NORMA vydaná dňa 1.12.2011

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Informácie o norme:

Označenie normy: ASTM F2883-11
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.12.2011
Kód tovaru: NS-54666
Počet strán: 7
Približná hmotnosť: 21 g (0.05 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM

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Kategórie - podobné normy:

Anotácia textu normy ASTM F2883-11 :

Keywords:
biological, calcium phosphate, calcium sulfate, ceramic, characterization, chemical, hydroxyapatite, implant, mechanical, mineral, physical, scaffold, TCP, Surgical implants, TEMPs (tissue engineered medical products), Ceramic surgical materials/applications, Scaffolds (medical), ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

Doplňujúce informácie

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. Scope

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

C373-18(2023)	Standard Test Methods for Determination of Water Absorption and Associated Properties by Vacuum Method for Pressed Ceramic Tiles and Glass Tiles and Boil Method for Extruded Ceramic Tiles and Non-tile Fired Ceramic Whiteware Products
C693-93(2019)	Standard Test Method for Density of Glass by Buoyancy
C729-11(2022)	Standard Test Method for Density of Glass by the Sink-Float Comparator
C830-00(2023)	Standard Test Methods for Apparent Porosity, Liquid Absorption, Apparent Specific Gravity, and Bulk Density of Refractory Shapes by Vacuum Pressure
C1198-20	Standard Test Method for Dynamic Young´s Modulus, Shear Modulus, and Poisson´s Ratio for Advanced Ceramics by Sonic Resonance
C1274-12(2020)	Standard Test Method for Advanced Ceramic Specific Surface Area by Physical Adsorption
C1424-15(2019)	Standard Test Method for Monotonic Compressive Strength of Advanced Ceramics at Ambient Temperature
D695-23	Standard Test Method for Compressive Properties of Rigid Plastics
E1131-20	Standard Test Method for Compositional Analysis by Thermogravimetry
F1634-95(2000)	Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
F1635-16	Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F1983-23	Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
F2024-10(2021)	Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
E1504-11(2019)	Standard Practice for Reporting Mass Spectral Data in Secondary Ion Mass Spectrometry (SIMS)
E2070-23	Standard Test Methods for Kinetic Parameters by Differential Scanning Calorimetry Using Isothermal Methods
E2253-21	Standard Test Method for Temperature and Enthalpy Measurement Validation of Differential Scanning Calorimeters
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1088-23	Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
E1252-98(2021)	Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis
E1269-11(2018)	Standard Test Method for Determining Specific Heat Capacity by Differential Scanning Calorimetry
E1298-06	Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
D6420-18	Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry
E1635-06(2019)	Standard Practice for Reporting Imaging Data in Secondary Ion Mass Spectrometry (SIMS)
E1642-00(2016)	Standard Practice for General Techniques of Gas Chromatography Infrared (GC/IR) Analysis
E1829-14(2020)	Standard Guide for Handling Specimens Prior to Surface Analysis
E1876-22	Standard Test Method for Dynamic Young´s Modulus, Shear Modulus, and Poisson´s Ratio by Impulse Excitation of Vibration
E456-13a(2022)	Standard Terminology Relating to Quality and Statistics (Includes all amendments and changes 4/21/2022).
E691-23	Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
E996-19	Standard Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron Spectroscopy
E1078-14(2020)	Standard Guide for Specimen Preparation and Mounting in Surface Analysis
E177-20	Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E128-99(2019)	Standard Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
D4404-18	Standard Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry
D6226-21	Standard Test Method for Open Cell Content of Rigid Cellular Plastics
ISO 9001	Quality Management Systems--Requirements
F2450-18	Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2809-10	Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
D1621-16(2023)	Standard Test Method for Compressive Properties of Rigid Cellular Plastics
F1185-23	Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
F2150-19	Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products