• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 15-52
Standard
ASTM F2064-17
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
Standard is recognized on a scientific basis: Material Characterization.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for medical devices/combination products where tissue engineering is a component of the development and manufacture of the product.
FDA Technical Contact
 David Kaplan
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2519
  david.kaplan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Tissue Engineering
*These are provided as examples and others may be applicable.
-
-