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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

F565 Practice for Care and Handling of Orthopedic Implants and Instruments

F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications

F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

F2451 Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

Keywords

animal models; biomaterials; bone; bone regeneration; bone repair; defect generation; devices; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs (Tissue Engineered Medical Products); Animal experimentation; Biomaterials; Bone regeneration; Medical devices/equipment; Synthetic bone; Tissue engineered medical products (TEMPs) ;

ICS Code

ICS Number Code 11.100.10 (In vitro diagnostic test systems)

DOI: 10.1520/F2721-08

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