ASTM F2347-15
(Guide)Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Standard Guide for Characterization and Testing of Hyaluronan 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 hyaluronan. This guide can be used as an aid in the selection and characterization of the appropriate hyaluronan 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 hyaluronan. It may have use in the regulation of these devices by appropriate authorities.
4.2 The hyaluronan covered by this guide may be gelled, cross-linked, 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.
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 hyaluronan, physical and chemical characterization and testing, impurities profile, and performance-related tests.
SCOPE
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.
General Information
Relations
Buy Standard
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: F2347 − 15
Standard Guide for
Characterization and Testing of Hyaluronan as Starting
Materials Intended for Use in Biomedical and Tissue
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2347; 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
Hyaluronan, which in this guide will encompass hyaluronic acid, hyaluronate, and its salt forms, is
the simplest of the glycosaminoglycans. Hyaluronan is soluble in water and forms highly viscous
solutions.Hyaluronanisfoundinubiquitouslyinthebodyaspartoftheextracellularmatrixoftissues,
with high concentrations in the synovial fluid, vitreous humor, and skin, as well as in cartilage.
Hyaluronan has found uses in a variety of products ranging from viscosupplements (treatment of
osteoarthritis), adhesion prevention (prevention of post-surgical adhesions), viscoelastics (ocular
protection), and dermal implants (lip augmentation and wrinkle removal). New applications, such as
scaffolds for tissue engineering, are emerging. The aim of this guide is to identify key parameters
relevant to the characterization of hyaluronan for the development of new commercial applications of
hyaluronan for the biomedical and pharmaceutical industries.
1. Scope* priate safety and health practices and determine the applica-
bility of regulatory requirements prior to use.
1.1 This guide covers the evaluation of hyaluronan suitable
for use in biomedical or pharmaceutical applications, or both,
2. Referenced Documents
including, but not limited to, Tissue Engineered Medical
2
2.1 ASTM Standards:
Products (TEMPs).
E1953 Practice for Description of Thermal Analysis and
1.2 This guide addresses key parameters relevant to the
Rheology Apparatus
characterization and purity of hyaluronan.
E2975 Test Method for Calibration of Concentric Cylinder
Rotational Viscometers
1.3 As with any material, some characteristics of hyaluro-
nan may be altered by processing techniques, such as cross- F619 Practice for Extraction of Medical Plastics
F748 PracticeforSelectingGenericBiologicalTestMethods
linking and sterilization, required for the production of a
specific formulation or device. Therefore, properties of fabri- for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracuta-
cated forms of this polymer should be evaluated using test
methods that are appropriate to ensure safety and efficacy and neous Injection in the Rabbit
F756 Practice for Assessment of Hemolytic Properties of
are not addressed in this guide.
Materials
1.4 The values stated in SI units are to be regarded as
F763 Practice for Short-Term Screening of Implant Materi-
standard. No other units of measurement are included in this
als
standard.
F813 Practice for Direct Contact Cell Culture Evaluation of
1.5 This standard does not purport to address all of the
Materials for Medical Devices
safety concerns, if any, associated with its use. It is the
F895 TestMethodforAgarDiffusionCellCultureScreening
responsibility of the user of this standard to establish appro-
for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomate-
rials for Surgical Implants with Respect to Effect of
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devicesand 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 Dec. 1, 2015. Published February 2016. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2003. Last previous edition approved in 2011 as F2347 – 11. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2347-15. the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2347 − 15
Materials on Muscle and Bone ICH Q1A Harmonized Tripartite Guidance for Stability
F1439 Guide for Performance of Lifetime Bioassay for the TestingofNewDrugSubstancesandProducts(September
6
Tumorigenic Potential of Implant Materials 2001, Revision 1)
F1903 Practice for Testing For Biological Responses to FDA Guideline on Validation of the Limulus Amebocyte
...
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: F2347 − 11 F2347 − 15
Standard Guide for
Characterization and Testing of Hyaluronan as Starting
Materials Intended for Use in Biomedical and Tissue
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F2347; 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
Hyaluronan, which in this guide will encompass hyaluronic acid, hyaluronate, and its salt forms, is
the simplest of the glycosaminoglycans. Hyaluronan is soluble in water and forms highly viscous
solutions. Hyaluronan is found in ubiquitously in the body as part of the extracellular matrix of tissues,
with high concentrations in the synovial fluid, vitreous humor, and skin, as well as in cartilage.
Hyaluronan has found uses in a variety of products ranging from viscosupplements (treatment of
osteoarthritis), adhesion prevention (prevention of post-surgical adhesions), viscoelastics (ocular
protection), and dermal implants (lip augmentation and wrinkle removal). New applications, such as
scaffolds for tissue engineering, are emerging. The aim of this guide is to identify key parameters
relevant to the characterization of hyaluronan for the development of new commercial applications of
hyaluronan for the biomedical and pharmaceutical industries.
1. Scope Scope*
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D2196E1953 Test Methods for Rheological Properties of Non-Newtonian Materials by Rotational ViscometerPractice for
Description of Thermal Analysis and Rheology Apparatus
E2975 Test Method for Calibration of Concentric Cylinder Rotational Viscometers
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F749 Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
Current edition approved March 1, 2011Dec. 1, 2015. Published March 2011February 2016. Originally approved in 2003. Last previous edition approved in 20032011
as F2347 – 03.F2347 – 11. DOI: 10.1520/F2347-11.10.1520/F2347-15.
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.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2347 − 15
F756 Practice for Assessment of Hemolytic Properties of Materials
F763 Practice for Short-Term Screening of Implant Materials
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
F1251 Terminology Rela
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.