ASTM F 2347 : 2015 : REDLINE
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
07-10-2024
English
01-12-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 13.01, 2016 Defines the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).
| Committee |
F 04
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| DocumentType |
Redline
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| Pages |
10
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy |
1.1This 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).
1.2This guide addresses key parameters relevant to the characterization and purity of hyaluronan.
1.3As 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.
1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 requirements prior to use.
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