ASTM F2451-05(2010)

Standard Guide for <i>in vivo</i> Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)

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 intended for the clinical repair or regeneration of articular cartilage.
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 utilize appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials or devices, 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 IDE (Investigational Device Exemption), PMA (Premarket Approval), or 510K submissions should conform to appropriate FDA guidelines for development of medical devices.
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 implantable devices intended to repair or regenerate articular cartilage. Devices 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.
1.2 Guidelines include a description and rationale of various animal models utilizing a range of species such as rabbit (lupine), dog (canine), pig (porcine), goat (caprine), sheep (ovine), and horse (equine). Outcome measures based on histologic, biochemical, and mechanical analyses are briefly described 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 product. ASTM standards for these steps are available in Reference Documents.
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.
WITHDRAWN RATIONALE
This guide covered general guidelines for the in vivo assessment of implantable devices intended to repair or regenerate articular cartilage.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in January 2019 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-2010
• Withdrawal Date: 15-Jan-2019
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.44 - Assessment for TEMPs

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2451 − 05 (Reapproved 2010)
Standard Guide for
in vivo Assessment of Implantable Devices Intended to
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Repair or Regenerate Articular Cartilage
This standard is issued under the fixed designation F2451; 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 Devices, and Associated Tissues and Fluids
F565 PracticeforCareandHandlingofOrthopedicImplants
1.1 This guide covers general guidelines for the in vivo
and Instruments
assessment of implantable devices intended to repair or regen-
F895 TestMethodforAgarDiffusionCellCultureScreening
erate articular cartilage. Devices included in this guide may be
for Cytotoxicity
composed of natural or synthetic biomaterials (biocompatible
F981 Practice for Assessment of Compatibility of Biomate-
and biodegradable) or composites thereof and may contain
rials for Surgical Implants with Respect to Effect of
cells or biologically active agents such as growth factors,
Materials on Muscle and Bone
synthetic peptides, plasmids, or cDNA.
F1983 Practice for Assessment of Compatibility of
1.2 Guidelinesincludeadescriptionandrationaleofvarious
Absorbable/Resorbable Biomaterials for ImplantApplica-
animal models utilizing a range of species such as rabbit
tions
(lupine), dog (canine), pig (porcine), goat (caprine), sheep
F2150 Guide for Characterization and Testing of Biomate-
(ovine), and horse (equine). Outcome measures based on
rial Scaffolds Used in Tissue-Engineered Medical Prod-
histologic, biochemical, and mechanical analyses are briefly
ucts
described and referenced. The user should refer to specific test
2.2 Other Documents:
methods for additional detail.
ISO-10993 Biological Evaluation of Medical Devices—Part
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1.3 This guide is not intended to include the testing of raw
5: Tests for in vitro Cytotoxicity
materials, preparation of biomaterials, sterilization, or packag-
21 CFR Part 58 Good Laboratory Practice for Nonclinical
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ing of product.ASTM standards for these steps are available in
Laboratory Studies
Reference Documents.
3. Terminology
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this 3.1 Definitions:
standard. 3.1.1 cartilage regeneration—the formation of articular-like
cartilage that has histologic, biochemical, and mechanical
1.5 This standard does not purport to address all of the
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properties similar to that of native articular cartilage (1, 2).
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 3.1.2 cartilage repair—the process of healing injured carti-
priate safety and health practices and determine the applica- lage or its replacement through cell proliferation and synthesis
bility of regulatory requirements prior to use. of new extracellular matrix (1, 2).
3.1.3 compact bone—classification of ossified boney con-
2. Referenced Documents
nective tissue characterized by the presence of osteons con-
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2.1 ASTM Standards: taining lamellar bone.
F561 Practice for Retrieval and Analysis of Medical
3.1.4 femoral condyles—the anatomic site corresponding to
the distal end of the femur characterized by medial and lateral
convex surfaces that are lined by cartilage and articulate with
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This guide is under the jurisdiction of ASTM Committee F04 on Medical and
the proximal tibia and medial and lateral menisci.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.44 on Assessment for TEMPs.
Current edition approved Sept. 1, 2010. Published November 2010. Originally
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approved in 2005. Last previous edition approved in 2005 as F2451 – 05. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2451-05R10. 4th Floor, New York, NY 10036.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
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Standards volume information, refer to the standard’s Document Summary page on The boldface numbers in parentheses refer to the list of references at the end of
the ASTM website. this standard.
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F2451 − 05 (2010)
3.1.5 fibrocartilage—disorganized cartilagenous tissue hav- 4. Significance and Use
ing an abnormally high content of type I collagen.
4.1 This guide is aimed at
...