ASTM F2529-13(2021)
Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)

Standard No.

ASTM F2529-13(2021)

Release Date

2021

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F2529-13(2021)

Scope

1.1 This guide covers general guidelines to evaluate the effectiveness of DBM-containing products intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents) to make the demineralized bone easier to manipulate. It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of unique bone-forming products in in vivo heterotopic models of osteoinductivity. The purpose of this guide is not to exclude other established methods. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with the use of DBMcontaining bone-forming/promoting products. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product. 1.4 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 F2529-13(2021) Referenced Document

• ANSI/AAMI/ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ANSI/AAMI/ISO 11137 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
• ASTM D1193 Standard Specification for Reagent Water
• ASTM D5056 Standard Test Method for Trace Metals in Petroleum Coke by Atomic Absorption
• ASTM E508 Standard Test Method for Calcium and Magnesium in Iron Ores by Atomic Absorption Spectrometry
• ASTM F1854 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
• ASTM F2131 Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line*， 2021-10-01 Update
• ASTM F2721 Standard Guide for Preclinical in vivo Evaluation in Critical-Size Segmental Bone Defects*， 2023-03-01 Update
• 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 F2529-13(2021) history

• 2021 ASTM F2529-13(2021) Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
• 2013 ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)