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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D2196 Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational (Brookfield type) Viscometer

F619 Practice for Extraction of Medical Plastics

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

F756 Practice for Assessment of Hemolytic Properties of Materials

F763 Practice for Short-Term Screening of Implant Materials

F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

F1439 Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

F1903 Practice for Testing For Biological Responses to Particles In Vitro

F1904 Practice for Testing the Biological Responses to Particles in vivo

F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity

F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration

USP Document

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;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2064-00

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