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ASTM International - ASTM F2027-16

Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

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Organization: ASTM International
Publication Date: 1 October 2016
Status: active
Page Count: 7
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
significance And Use:

4.1 The physico-chemical characteristics of the raw or starting material used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell... View More

scope:

1.1 This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials that are already in a scaffold form or are finished tissue-engineered medical products.

1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for materials already commonly used within medical products and to provide characterization guidance for interim use of raw materials for which a standard does not exist.

1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals.

1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques.

1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.

abstract:

This guide addresses material characteristics of raw or virgin materials in a nonfabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for... View More

Document History

ASTM F2027-16
October 1, 2016
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
1.1 This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells...
May 1, 2008
Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
1.1 This document provides guidance on writing a materials specification for raw or starting biomaterials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells...
May 10, 2000
Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
1.1 This guide addresses material characteristics of raw or virgin materials in a non-fabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for...
May 10, 2000
Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
1.1 This guide addresses material characteristics of raw or virgin materials in a non-fabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for...
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