ASTM F2721-09(2023)
Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects
- Standard No.
- ASTM F2721-09(2023)
- Release Date
- 2023
- Published By
- American Society for Testing and Materials (ASTM)
- Latest
- ASTM F2721-09(2023)
- 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 preclinical 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 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.
ASTM F2721-09(2023) 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(2023) 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
