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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 potential attributes for 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.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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 cells or biomolecules. The substrate material shall have specifications for an extensive set of chemical and physical properties prescribed. Test methods shall be performed in order to determine the chemical and physical properties of the material.
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 mechanical properties, chemical reactions, cell behavior, and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting materials to ensure reproducibility prior to their fabrication into implantable tissue-engineering scaffolds and/or controlled release matrices.
4.2 In all cases, the specifications for any single product should be chosen with primary consideration to that product’s safety and performance requirements and risks. This guide provides typical attributes that will not all be necessary and will not always be sufficient.
| SDO | ASTM: ASTM International |
| Document Number | F2027 |
| Publication Date | Jan. 1, 2025 |
| Language | en - English |
| Page Count | 8 |
| Revision Level | 25 |
| Supercedes | |
| Committee | F04.42 |
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