ASTM-F2064 › Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
The following bibliographic material is provided to assist you with your purchasing decision:
Changes from the previous issue
A redline edition is available for this document, with all changes visible. Ask Document Center Inc. for more information.
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.
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.
Keywords
alginates; biomedically engineered; tissue-engineered medical products;; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-E399Standard Test Method for Linear-Elastic Plane-Strain Fracture Toughness K<inf>Ic</inf > of Metallic Materials
ASTM-C1361
Standard Practice for Constant-Amplitude, Axial, Tension-Tension Cyclic Fatigue of Advanced Ceramics at Ambient Temperatures
AAMI-ST72
Bacterial endotoxin - Test methods, routine monitoring and alternatives to batch testing
Document Number
ASTM-F2064-17
Revision Level
2017 EDITION
Status
Current
Modification Type
Revision
Publication Date
May 1, 2017
Document Type
Guide
Page Count
9 pages
Committee Number
F04.42