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ASTM F2064-00
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application
8 стр.
Заменен
Электронный (pdf)Печатное издание
93.60 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы
Сборник (ASTM):
13.01 Medical and Surgical Materials and Devices (I): E667 – F2477 / Медицинские и хирургические материалы и приборы (I): E667 - F2477
Тематика:
Medical Devices & Implants
Описание
Область применения

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.

Ключевые слова:
alginates; biomedically engineered; tissue-engineered medical products