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ASTM F 2064 : 2017 : REDLINE

Current

Current

The latest, up-to-date edition.

Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

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PDF

Language(s)

English

Published date

01-03-2017

€67.30
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CONTAINED IN VOL. 13.01, 2017 Defines the evaluation of alginates suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).

Committee
F 04
DocumentType
Redline
Pages
10
PublisherName
American Society for Testing and Materials
Status
Current

1.1This 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).

1.2This guide addresses key parameters relevant for the functionality, characterization, and purity of alginates.

1.3As 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.

1.4Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

1.5This 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.

1.6This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2211 : 2013 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F 2605 : 2016 : REDLINE Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
ASTM F 2259 : 2010 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy
ASTM F 2259 : 2010 : R2012 : EDT 1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (<sup>1</sup>H NMR) Spectroscopy (Withdrawn 2021)

AAMI TIR19 : 1998 GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ASTM F 756 : 2017 : REDLINE Standard Practice for Assessment of Hemolytic Properties of Materials
CFR 21(PTS170-199) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199
ASTM F 749 : 2013 : REDLINE Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
ASTM F 1903 : 2010-07 PRACTICE FOR TESTING FOR BIOLOGICAL RESPONSES TO PARTICLES IN VITRO
ASTM F 2605 : 2016 : REDLINE Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ASTM F 1904 : 2014 : REDLINE Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph>
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products

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