ASTM F2064-17
(Guide)Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
SIGNIFICANCE AND USE
4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of alginate. This guide can be used as an aid in the selection and characterization of the appropriate alginate for a particular application. This guide is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular alginate. It may have use in the regulation of these devices by appropriate authorities.
4.2 The alginate covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use in tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application. Further guidance for immobilizing or encapsulating living cells or tissue in alginate gels can be found in Guide F2315.
4.3 To ensure that the material supplied satisfies requirements for use in TEMPS, several general areas of characterization should be considered. These are: identity of alginate, physical and chemical characterization and testing, impurities profile, and performance-related tests.
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 Warning—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.
1.5 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.
1.6 This 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.
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Standards Content (Sample)
This 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.
Designation: F2064 − 17
Standard Guide for
Characterization and Testing of Alginates as Starting
Materials Intended for Use in Biomedical and Tissue
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2064; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Alginatehasfoundusesinavarietyofproductsrangingfromsimpletechnicalapplicationssuchas
viscosifiers to advanced biomedical matrices providing controlled drug delivery from immobilized
living cells. As for most hydrocolloids, the functionality of alginate is related to its chemical and
structural composition. The aim of this guide is to identify key parameters relevant for the
functionalityandcharacterizationofalginatesforthedevelopmentofnewcommercialapplicationsof
alginates for the biomedical and pharmaceutical industries.
1. Scope 1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 Thisguidecoverstheevaluationofalginatessuitablefor
responsibility of the user of this standard to establish appro-
use in biomedical or pharmaceutical applications, or both,
priate safety and health practices and determine the applica-
including, but not limited to, Tissue Engineered Medical
bility of regulatory limitations prior to use.
Products (TEMPs).
1.6 This international standard was developed in accor-
1.2 This guide addresses key parameters relevant for the
dance with internationally recognized principles on standard-
functionality, characterization, and purity of alginates.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.3 As with any material, some characteristics of alginates
may be altered by processing techniques (such as molding, mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
extrusion, machining, assembly, sterilization, and so forth)
required for the production of a specific part or device.
2. Referenced Documents
Therefore, properties of fabricated forms of this polymer
2
should be evaluated using test methods that are appropriate to
2.1 ASTM Standards:
ensure safety and efficacy and are not addressed in this guide.
E2975Test Method for Calibration or Calibration Verifica-
tion of Concentric Cylinder Rotational Viscometers
1.4 Warning—Mercury has been designated by EPA and
F619Practice for Extraction of Medical Plastics
many state agencies as a hazardous material that can cause
F748PracticeforSelectingGenericBiologicalTestMethods
central nervous system, kidney, and liver damage. Mercury, or
for Materials and Devices
its vapor, may be hazardous to health and corrosive to
F749Practice for Evaluating Material Extracts by Intracuta-
materials.Cautionshouldbetakenwhenhandlingmercuryand
neous Injection in the Rabbit
mercury-containing products. See the applicable product Ma-
F756Practice for Assessment of Hemolytic Properties of
terial Safety Data Sheet (MSDS) for details and EPA’s website
Materials
(http://www.epa.gov/mercury/faq.htm) for additional informa-
F763Practice for Short-Term Screening of Implant Materi-
tion. Users should be aware that selling mercury or mercury-
als
containingproducts,orboth,inyourstatemaybeprohibitedby
F813Practice for Direct Contact Cell Culture Evaluation of
state law.
Materials for Medical Devices
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.42 on Biomaterials and Biomolecules for TEMPs. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 1, 2017. Published April 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2014 as F2064–14. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2064-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2064 − 17
7
F895TestMethodforAgarDiffusionCellCultureScreening 2.5 FDA Documents:
for Cytotoxicity FDA Interim Guidance for Human and Veterinary Drug
F981Practice for Assessment of Compatibility of Biomate- Products and Biologicals. Kinetic LAL techniques.
rials for S
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2064 − 14 F2064 − 17
Standard Guide for
Characterization and Testing of Alginates as Starting
Materials Intended for Use in Biomedical and Tissue
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2064; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Alginate has found uses in a variety of products ranging from simple technical applications such as
viscosifiers to advanced biomedical matrices providing controlled drug delivery from immobilized
living cells. As for most hydrocolloids, the functionality of alginate is related to its chemical and
structural composition. The aim of this guide is to identify key parameters relevant for the
functionality and characterization of alginates for the development of new commercial applications of
alginates for the biomedical and pharmaceutical industries.
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 Warning—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.
1.5 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.
1.6 This 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D2196E2975 Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational ViscometerMethod for
Calibration or Calibration Verification of Concentric Cylinder Rotational Viscometers
F619 Practice for Extraction of Medical Plastics
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
Current edition approved Oct. 1, 2014March 1, 2017. Published February 2015April 2017. Originally approved in 2000. Last previous edition approved in 20002014 as
ε1
F2064 – 00 (2006)F2064 – 14. . DOI: 10.1520/F2064-14.10.1520/F2064-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2064 − 17
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
...
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