ASTM F2064-2000(2006)
生物医学和组织工程医学产品用的作为原材料的藻酸盐的特性和测试标准指南

Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application

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标准号

ASTM F2064-2000(2006)

发布日期

2000年

实施日期

废止日期

无

中国标准分类号

C30

国际标准分类号

11.040.40 (Implants for surgery, prothetics and or

发布单位

US-ASTM

适用范围

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.