ASTM F2347 - 15 - Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Application

ASTM F2347 - 15

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

Status : Current   Published : December 2015

Format
PDF

Format
HARDCOPY



1.1 This guide covers the evaluation of hyaluronan 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 to the characterization and purity of hyaluronan.

1.3 As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as cross-linking and sterilization, required for the production of a specific formulation 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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 requirements prior to use.




Standard NumberASTM F2347 - 15
TitleStandard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Application
StatusCurrent
Publication Date01 December 2015
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Biomaterials, Biopolymer, Hyaluronan, Polysaccharide, TEMPs
ICS11.120.99
PublisherASTM
FormatA4
DeliveryYes
Pages10
File Size186 KB
Price£40.00


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