ASTM F1714-96(2013)..
ASTM F1717-14
ASTM F1781-03(2009)..
ASTM F1798-13
ASTM F1800-12
ASTM F1801-97(2009)e..
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ASTM F2027-08
Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
Automatische name übersetzung:
Standard-Handbuch für die Charakterisierung und Prüfung von Raw oder Ab Biomaterialien für Tissue-Engineering Medical Products
NORM herausgegeben am 1.5.2008
Informationen über die Norm:
Bezeichnung normen: ASTM F2027-08
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 1.5.2008
SKU: NS-52503
Zahl der Seiten: 7
Gewicht ca.: 21 g (0.05 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Kategorie - ähnliche Normen:
Die Annotation des Normtextes ASTM F2027-08 :
Keywords:
biomaterials, ceramics, composites, materials, metals, natural products, polymers, regenerative medicine, tissue-engineered medical products, Biomedical materials/applications, Ceramic surgical materials/applications, Characteristics/characterization, Engineered medical products, Polymers (surgical applications), Substrates--surgical implant applications, TEMPs (tissue engineered medical products), ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Ergänzende Informationen
| Significance and Use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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The physico-chemical characteristics of the raw or starting biomaterial used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting biomaterials to ensure reproducibility prior to their fabrication into implantable tissue engineering scaffolds and/or controlled release matrices. |
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| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 and/or biomolecules. This guide does not apply to biomaterials 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 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. 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 intend use may be required. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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