ASTM F2212-20
(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
4.1 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.
4.2 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.
4.3 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.
4.4 The following documents or other appropriate guidances from appropriate regulatory bodies 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 ...
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 or 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)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...
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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: F2212 − 20
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 F2212; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) 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 gelatin or tissue implants. This guide may serve as a template
for characterization of other types of collagen.
1.1 This guide for characterizing collagen-containing bio-
materials is intended to provide characteristics, properties, and 1.2 The biological response to collagen in soft tissue has
2
test methods for use by producers, manufacturers, and re- been well documented by a history of clinical use (1, 2) and
searchers to more clearly identify the specific collagen mate- laboratory studies (3-6). Biocompatibility and appropriateness
rials used. With greater than 20 types of collagen and the of use for a specific application(s) is the responsibility of the
different properties of each, a single document would be product manufacturer.
cumbersome. This guide will focus on the characterization of
1.3 The values stated in SI units are to be regarded as
Type I collagen, which is the most abundant collagen in
standard. No other units of measurement are included in this
mammals, especially in skin and bone. Collagen isolated from
standard.
thesesourcesmaycontainothertypesofcollagen,forexample,
1.4 Warning—Mercury has been designated by EPA and
Type III and Type V. This guide does not provide specific
many state agencies as a hazardous material that can cause
parameters for any collagen product or mix of products or the
central nervous system, kidney, and liver damage. Mercury, or
acceptability of those products for the intended use. The
its vapor, may be hazardous to health and corrosive to
collagen may be from any source including, but not limited to,
materials.Cautionshouldbetakenwhenhandlingmercuryand
animal or cadaveric sources, human cell culture, or recombi-
mercury-containing products. See the applicable product Ma-
nant sources. The biological, immunological, or toxicological
terial Safety Data Sheet (MSDS) for details and EPA’s website
properties of the collagen may vary, depending on the source
(http://www.epa.gov/mercury/faq.htm) for additional informa-
material. The properties of the collagen prepared from each of
tion. Users should be aware that selling mercury or mercury-
the above sources must be thoroughly investigated, as the
containingproducts,orboth,inyourstatemaybeprohibitedby
changes in the collagen properties as a function of source
state law.
materials is not thoroughly understood. This guide is intended
1.5 The following precautionary caveat pertains only to the
to focus on purified Type I collagen as a starting material for
surgical implants and substrates for tissue engineered medical test method portion, Section 5, of this guide. This standard
does not purport to address all of the safety concerns, if any,
products (TEMPs); some methods may not be applicable for
associated with its use. It is the responsibility of the user of this
standard to establish appropriate safety, health, and environ-
mental practices and determine the applicability of regulatory
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and
limitations prior to use.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.42 on Biomaterials and Biomolecules for TEMPs.
Current edition approved Dec. 1, 2020. Published January 2021. Originally
2
approved in 2002. Last previous edition approved in 2019 as F2212–19. DOI: Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
10.1520/F2212-20. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
...
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: F2212 − 19 F2212 − 20
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 F2212; 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
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
1.1 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 or tissue implants. This guide may serve as a template for characterization of other types
of collagen.
2
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 (33-6, 4, 5, 6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product
manufacturer.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 Sept. 1, 2019Dec. 1, 2020. Published December 2019January 2021. Originally approved in 2002. Last previous edition approved in 20112019
as F2212 – 11F2212 – 19. . DOI: 10.1520/F2212-19.10.1520/F2212-20.
2
The boldface numbers in parentheses refer to the list of references 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 ----------------------
F2212 − 20
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central
nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution
should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet
(MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware
that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.
1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this g
...
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