ASTM F2212-08
(Guide)Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
SIGNIFICANCE AND USE
The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.
The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on 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.
The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.
The following documents relating to the production, regulation and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs: FDA CFR: 21 CFR 3: Product Jurisdiction: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=58 FDA/CDRH CFR and Guidances: 21 CFR Part 803: Medical Device Reporting: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=803 21 CFR 812: Investigational...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source, including, but not limited to animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin nor for tissue implants. This guide may serve as a template for characterization of other types of collagen.
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2) and laboratory studies (3, 4, 5, 6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.
1.3 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. T...
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Designation:F2212–08
Standard Guide for
Characterization of Type I Collagen as Starting Material for
Surgical Implants and Substrates for Tissue Engineered
1
Medical Products (TEMPs)
This standard is issued under the fixed designation F 2212; 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 (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Collagen-based medical products are becoming more prevalent, especially in the area of soft tissue
augmentation. The use of collagen in surgery dates back to the late 1800s, with the use of catgut
sutures, human cadaveric skin, and fascia. More recently, collagen has been used in hemostatic
sponges, dermal equivalents, injectables for soft tissue augmentation, as a matrix for cell-based
products and as a vehicle for drug delivery. It is because of the versatility of collagen in medical
applications that specific characterizations should be performed as a way to compare materials.
1. Scope 1.2 The biological response to collagen in soft tissue has
2
been well documented by a history of clinical use (1, 2) and
1.1 This guide for characterizing collagen-containing bio-
laboratory studies (3, 4, 5, 6). Biocompatibility and appropri-
materials is intended to provide characteristics, properties, and
ateness of use for a specific application(s) is the responsibility
test methods for use by producers, manufacturers, and re-
of the product manufacturer.
searchers to more clearly identify the specific collagen mate-
1.3 The following precautionary caveat pertains only to the
rials used. With greater than 20 types of collagen and the
test method portion, Section 5, of this guide. This standard
different properties of each, a single document would be
does not purport to address all of the safety concerns, if any,
cumbersome. This guide will focus on the characterization of
associated with its use. It is the responsibility of the user of this
Type I collagen, which is the most abundant collagen in
standard to establish appropriate safety and health practices
mammals, especially in skin and bone. Collagen isolated from
and determine the applicability of regulatory requirements
thesesourcesmaycontainothertypesofcollagen,forexample,
prior to use.
Type III and Type V. This guide does not provide specific
parameters for any collagen product or mix of products or the
2. Referenced Documents
acceptability of those products for the intended use. The
3
2.1 ASTM Standards:
collagen may be from any source, including, but not limited to
E 1298 Guide for Determination of Purity, Impurities, and
animal or cadaveric sources, human cell culture, or recombi-
Contaminants in Biological Drug Products
nant sources. The biological, immunological, or toxicological
F 619 Practice for Extraction of Medical Plastics
properties of the collagen may vary depending on the source
F 720 Practice for Testing Guinea Pigs for Contact Aller-
material. The properties of the collagen prepared from each of
gens: Guinea Pig Maximization Test
the above sources must be thoroughly investigated, as the
F 748 Practice for Selecting Generic Biological Test Meth-
changes in the collagen properties as a function of source
ods for Materials and Devices
materials is not thoroughly understood. This guide is intended
F 749 Practice for Evaluating Material Extracts by Intracu-
to focus on purified Type I collagen as a starting material for
taneous Injection in the Rabbit
surgical implants and substrates for tissue engineered medical
F 756 Practice for Assessment of Hemolytic Properties of
products (TEMPs); some methods may not be applicable for
Materials
gelatin nor for tissue implants. This guide may serve as a
template for characterization of other types of collagen.
2
The boldface numbers in parentheses refer to the list of references at the end of
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and this standard.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.42 on Biomaterials and Biomolecules for TEMPs. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Feb. 1, 2008. Published March 2008. Originally Standards volume information, refer to the standard’s Document Summary page on
e1
approved in 2002. Last previous edition approved in 2007 as F 2212 – 02 (2007) . the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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F2212–08
6
F 763 Practice for Sh
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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.
e1
Designation:F2212–02 (Reapproved 2007) Designation:F2212–08
Standard Guide for
Characterization of Type I Collagen as Starting Material for
Surgical Implants and Substrates for Tissue- Engineered
1
Medical Products (TEMPs)
This standard is issued under the fixed designation F 2212; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Formatting and grammar were corrected editorially throughout in April 2007.
INTRODUCTION
Collagen-basedmedicaldevicesproductsarebecomingmoreprevalent,especiallyintheareaofsoft
tissueaugmentation.Theuseofcollageninsurgerydatesbacktothelate1800s,withtheuseofcatgut
sutures, human cadaveric skin, and fascia. More recently, collagen has been used in hemostatic
sponges, dermal equivalents, injectables for soft tissue augmentation, as a matrix for cell-based
products and as a vehicle for drug delivery. It is because of the versatility of collagen in medical
applications that specific characterizations should be performed as a way to compare materials.
1. Scope
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test
methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With
greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will
focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone.
Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not
provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use.
The collagen may be from any source, including, but not limited to,to animal or cadaveric sources, human cell culture, or
recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary,vary depending on the
source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the
changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus
onpurifiedTypeIcollagenasastartingmaterialforsurgicalimplantsandsubstratesforTissue-EngineeredMedicalProductstissue
engineered medical products (TEMPs); some methods may not be applicable for gelatin nor for tissue implants. This guide may
serve as a template for characterization of other types of collagen.
2
1.2 Thebiologicalresponsetocollageninsofttissuehasbeenwelldocumentedbyahistoryofclinicaluse(1,2) andlaboratory
studies (3, 4, 5, 216). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the
deviceproduct manufacturer.
1.3 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. 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
3
2.1 ASTM Standards:
E 1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
F 619 Practice for Extraction of Medical Plastics
F 720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
Current edition approved Feb. 1, 2007.2008. Published February 2007.March 2008. Originally approved in 2002. Last previous edition approved in 20022007 as
e1
F 2212 – 02 (2007) .
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbo
...
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