ASTM F2064-00(2006) - 1.3.2006
 
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

F895-11(2016)

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F813-20

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

F763-22

Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials

D2196-20

Standard Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational Viscometer

F619-20

Standard Practice for Extraction of Materials Used in Medical Devices

F748-16

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

F749-20

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

F756-17

Standard Practice for Assessment of Hemolytic Properties of Materials

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

F1251-89(1995)

Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

F1439-03(2018)

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

F1903-18

Standard Practice for Testing for Cellular Responses to Particles in vitro

F1904-23

Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo

F2259-10

Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

F2315-18

Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

F2605-16

Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

F1905-98

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

F1906-98

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