ASTM F 2027 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
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ASTM F 2027 Document Information:
Title
Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
ASTM International
Publication Date:
May 1, 2008
Scope:
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 and/or biomolecules. This guide does not apply to
biomaterials that are already in a scaffold form or are finished
tissue-engineered medical products.
The purpose of this guide is to provide a compendium of relevant
existing standards and test methods for biomaterials already
commonly used within medical products and to provide
characterization guidance for interim use of raw biomaterials for
which a standard does not exist.
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.
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.
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 intend use may be required.
Keywords:
- biomaterials
- ceramics
- composites
- materials
- metals
- natural products
- polymers
- regenerative medicine
- tissue-engineered medical products
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