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Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application (Includes all amendments And changes 2/13/2015).
Automaticky přeložený název:
Standardní Průvodce pro charakterizaci a testování Algináty jako výchozí materiály určené pro použití v biomedicínském a tkáňového inženýrství Medical Products Aplikace
NORMA vydána dne 1.3.2006
Označení normy: ASTM F2064-00(2006)e1
Poznámka: NEPLATNÁ
Datum vydání normy: 1.3.2006
Kód zboží: NS-52649
Počet stran: 8
Přibližná hmotnost: 24 g (0.05 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
alginates, biomedically engineered, tissue-engineered medical products, Chemical characterization, Degradation--surgical devices/applications, Depolymerization, Engineered medical products, Functionality, Impurities--medical/surgical materials/applications, Molecular mass average, Performance--surgical materials/applications, Physical analysis/characterization, TEMPs (tissue engineered medical products), Alginates, Characteristics/characterization--surgical implants/applications
1. Scope | ||||||||||||||||||||||||||||||||||||
1.1 This guide covers the evaluation of alginates suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS). 1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of alginates. 1.3 As with any material, some characteristics of alginates may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide. 1.4 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. |
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2. Referenced Documents | ||||||||||||||||||||||||||||||||||||
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