ASTM F2721-09(2014)
Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects

Standard No.

ASTM F2721-09(2014)

Release Date

2009

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2721-09(2023)

Latest

ASTM F2721-09(2023)

Scope

4.1 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.

4.2 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.

4.3 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.

4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.

4.5 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.

4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.

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 performa......

ASTM F2721-09(2014) Referenced Document

• ASTM F1983 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
• ASTM F2150 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• ASTM F561 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
• ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F895 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

ASTM F2721-09(2014) history

• 2023 ASTM F2721-09(2023) Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects
• 2009 ASTM F2721-09(2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
• 2009 ASTM F2721-09 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
• 2008 ASTM F2721-08 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects