ASTM F2529-13(R2021) pdf free download

ASTM F2529-13(R2021) pdf free download.Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
1. 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 com- posed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic bio- materials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or han- dling agents) to make the demineralized bone easier to ma- nipulate. 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 DBM- containing bone-forming/promoting products. It is the respon- sibility 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 accor- dance with internationally recognized principles on standard- ization established in the Decision on Principles for the Development of International Standards, Guides and Recom- mendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
3. Terminology
3.1 Definitions: 3.1.1 additive—ingredients that may be used to preserve the product, provide radioprotection, and/or act as bulk filler and/or binding agent. 3.1.1.1 Discussion—It has no intended mode of action, such as causing cells to transform lineage, once implanted. 3.1.2 biologically active carrier—a component added to a DBM-containing bone-forming product that results in a physi- ological and/or biochemical transformation in the implant site independent of other constituents in the bone-forming product. 3.1.2.1 Discussion—The transformation may be desirable or untoward. A biologically active carrier may also contribute to the physical or chemical properties/characteristics of that bone-forming product. 3.1.3 bone—hard connective tissue of the skeletal system in vertebrates comprised of collagen, growth factors, and an inorganic rigid matrix containing calcium, phosphate and other minerals, and various cellular elements, including osteoblasts, osteocytes, osteoclasts, and hematopoietic cells. 3.1.3.1 Discussion—Bone is made up of cortical and can- cellous bone tissue. It serves as the point of attachment for muscles and tendons and is load-bearing. 3.1.4 bone-forming product (containing DBM)—as used in this guide, a DBM-containing bone-forming product may be comprised of multiple components including, but not restricted to, demineralized bone, growth factors, differentiation factors, osteoprogenitor cells, mesenchymal stem cells, biologically active carrier(s), and/or non-biologically active carrier(s). 3.1.5 bone marrow—tissue located in the cancellous portion and cavities (medullary canal) of most bones. 3.1.5.1 Discussion—Bone marrow is highly vascular and occurs in two forms: white/yellow marrow, comprised mostly of adipose cells located primarily in the long bones, and red marrow, which primarily produces and contains pluripotent stems cells and red blood cells, platelets, and white blood cells derived from them. In adults, red marrow is located primarily in the flat bones.3.1.7 cartilage—connective tissue that is a major constitu- ent of the embryonic and young vertebrate skeleton, largely replaced with bone and bone marrow bone with maturation. 3.1.7.1 Discussion—It is comprised mostly of Type II col- lagen and proteoglycans and found in joints, the outer ear, bronchi, and larynx. There are three major types of cartilage: hyaline cartilage, which is adapted for joint surfaces by virtue of its smoothness and ability to withstand compression; fibrocartilage, found in the outer ear, nose, and meniscus; and elastic cartilage, found in the outer ear and epiglottis. Cartilage is also formed by the action of bone morphogenetic protein(s) (BMPs) in concert with other peptide factors on mesenchymal stem cells.