ASTM F2721-09
(Guide)Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
Standard Guide for Pre-clinical <span class="bdit">in vivo</span> Evaluation in Critical Size Segmental Bone Defects
SIGNIFICANCE AND USE
This guide is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone.
This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.
The user is encouraged to use appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.
It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.
Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE)), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs, respectively.
Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.
SCOPE
1.1 This guide covers general guidelines for the in vivo assessment of tissue engineered medical products (TEMPs) intended to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this guide are segmental critical size defects which, by definition, will not fill with viable tissue without treatment. Thus, these models represent a stringent test of a material’s ability to induce or augment bone growth.
1.2 Guidelines include a description and rationale of various animal models including rat (murine), rabbit (leporine), dog (canine), goat (caprine), and sheep (ovine). Outcome measures based on radiographic, histologic, and mechanical analyses are described briefly and referenced. The user should refer to specific test methods for additional detail.
1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in the Referenced Documents (Section 2).
1.4 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.
1.5 Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 limitations prior to use.
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Designation: F2721 − 09
StandardGuide for
Pre-clinical in vivo Evaluation in Critical Size Segmental
1
Bone Defects
This standard is issued under the fixed designation F2721; 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.
1. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This guide covers general guidelines for the in vivo
bility of regulatory limitations prior to use.
assessment of tissue engineered medical products (TEMPs)
intended to repair or regenerate bone. TEMPs included in this
2. Referenced Documents
guide may be composed of natural or synthetic biomaterials
2
2.1 ASTM Standards:
(biocompatible and biodegradable) or composites thereof, and
F561 Practice for Retrieval and Analysis of Medical
may contain cells or biologically active agents such as growth
Devices, and Associated Tissues and Fluids
factors, synthetic peptides, plasmids, or cDNA. The models
F565 PracticeforCareandHandlingofOrthopedicImplants
described in this guide are segmental critical size defects
and Instruments
which, by definition, will not fill with viable tissue without
F895 TestMethodforAgarDiffusionCellCultureScreening
treatment. Thus, these models represent a stringent test of a
for Cytotoxicity
material’s ability to induce or augment bone growth.
F981 Practice for Assessment of Compatibility of Biomate-
1.2 Guidelinesincludeadescriptionandrationaleofvarious
rials for Surgical Implants with Respect to Effect of
animal models including rat (murine), rabbit (leporine), dog
Materials on Muscle and Bone
(canine), goat (caprine), and sheep (ovine). Outcome measures
F1983 Practice for Assessment of Compatibility of
based on radiographic, histologic, and mechanical analyses are
Absorbable/Resorbable Biomaterials for ImplantApplica-
described briefly and referenced. The user should refer to
tions
specific test methods for additional detail.
F2150 Guide for Characterization and Testing of Biomate-
1.3 This guide is not intended to include the testing of raw
rial Scaffolds Used in Tissue-Engineered Medical Prod-
materials, preparation of biomaterials, sterilization, or packag-
ucts
ing of the product. ASTM standards for these steps are
F2451 Guide forin vivo Assessment of Implantable Devices
available in the Referenced Documents (Section 2).
Intended to Repair or Regenerate Articular Cartilage
1.4 The use of any of the methods included in this guide
2.2 Other Documents:
may not produce a result that is consistent with clinical
ISO 10993 Biological Evaluation of Medical Devices—Part
3
performance in one or more specific applications.
5: Tests for in vitro Cytotoxicity
21 CFR Part 58 Good Laboratory Practice for Nonclinical
1.5 Other pre-clinical methods may also be appropriate and
4
Laboratory Studies
this guide is not meant to exclude such methods. The material
21 CFR 610.12 General Biological Products Standards—
must be suitable for its intended purpose.Additional biological
4
Sterility
testing in this regard would be required.
1.6 The values stated in SI units are to be regarded as
3. Terminology
standard. No other units of measurement are included in this
3.1 Definitions:
standard.
1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
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
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and the ASTM website.
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F04.44 on Assessment for TEMPs. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved June 1, 2009. Published June 2009. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
approved in 2008. Last previous version approved in 2008 as F2721 – 08. DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F2721-09. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2721 − 09
3.1.1 bone regeneration—the formation of bone that has 3.1.14 residence time—the time at which an implanted
histologic, biochemical, and mechanical properties similar to material (synthetic or
...
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.
Designation:F2721–08 Designation:F2721–09
Standard Guide for
Pre-clinical in vivo Evaluation in Critical Size Segmental
1
Bone Defects
This standard is issued under the fixed designation F 2721; 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.
1. Scope
1.1 This guide covers general guidelines for the in vivo assessment of tissue engineered medical products (TEMPs) intended
to repair or regenerate bone. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible
and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic
peptides, plasmids, or cDNA. The models described in this guide are segmental critical size defects which, by definition, will not
fill with viable tissue without treatment. Thus, these models represent a stringent test of a material’s ability to induce or augment
bone growth.
1.2 Guidelines include a description and rationale of various animal models including rat (murine), rabbit (leporine), dog
(canine), goat (caprine), and sheep (ovine). Outcome measures based on radiographic, histologic, and mechanical analyses are
described briefly and referenced. The user should refer to specific test methods for additional detail.
1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of
the product. ASTM standards for these steps are available in the Referenced Documents (Section 2).
1.4 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance
in one or more specific applications.
1.5 Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods.The material must
be suitable for its intended purpose. Additional biological testing in this regard would be required.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F 561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
F 565 Practice for Care and Handling of Orthopedic Implants and Instruments
F 895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F 1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
F 2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F 2451 Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
2.2 Other Documents:
3
ISO 10993 Biological Evaluation of Medical Devices—Part 5: Tests for in vitro Cytotoxicity
4
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
4
21 CFR 610.12 General Biological Products Standards—Sterility
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 F04.44
on Assessment for TEMPs.
Current edition approved Nov. 1, 2008. Published March 2009.
Current edition approved June 1, 2009. Published June 2009. Originally approved in 2008. Last previous version approved in 2008 as F 2721 – 08.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive
...
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