ASTM F2064-00(2006)e1

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).

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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

STANDARD published on 1.3.2006

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The information about the standard:

Designation standards: ASTM F2064-00(2006)e1
Note: WITHDRAWN
Publication date standards: 1.3.2006
SKU: NS-52649
The number of pages: 8
Approximate weight : 24 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F2064-00(2006)e1 :

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

Additional information

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

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