ASTM-F2883 2011

$40.63

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

Published By	Publication Date	Number of Pages
ASTM	2011	7

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Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

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Description

ASTM F2883-11

Withdrawn Standard: Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

ASTM F2883

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.

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 Code

ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

DOI: 10.1520/F2883-11

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents
3	Terminology Summary of Guide Significance and Use Chemical Properties and Tests
4	Physical Properties and Tests
5	Biological Properties
6	Mechanical Properties and Tests Sterilization and Storage Quality Assurance Keywords
7	X1. RATIONALE X1.1 X1.2 X2. BIOCOMPATIBILITY X2.1 X2.2

Additional information

Standard Title	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
Published Code	ASTM
Publication Date	2011
Pages Count	7
ICS Codes	11.100.99 - Other standards related to laboratory medicine