Subcommittees
F04.41-
F04.46, which deal with Tissue Engineered Medical Products (TEMPs), part of ASTM International Committee
F04 on Medical and Surgical Materials and Devices, will meet Oct. 27-28 at the National Physical Laboratory in Teddington, United Kingdom. The meeting will focus on the ongoing development of several proposed TEMPs-related standards.
Several TEMPS standards are currently recognized by the U.S. Food and Drug Administration, Center for Devices and Radiological Health, including
F2347, Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications, and
F2451, Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage. These standards are used for tissue engineered medical product development around the world.
Discussion of the following proposed standards is on the agenda for the F04.04 meeting:
- WK3551 Guide for the Assessment of Demineralized Bone Without Excipient
- WK8032 Guide for Pre-Clinical in vivo Evaluation of Critical Size Segmental Bone Defects
- WK8033 Guide for Performance Evaluation of Tendon and Ligament TEMPs Devices
- WK11381 Guide for Measurement of Surface Roughness and Contact Angles of Biomaterials
- WK11468 Guide for in situ Visualization/Quantification of Mineralized Matrix Formed by Mesenchymal Cell Culture
- WK15152 Guide for Characterization of Ceramic- and Mineral-Based Scaffolds Used for Tissue-Engineered Medical Products (TEMPs) and as Medical Devices for Surgical Implant Applications
- WK17626 Test Method for Quantifying the Spread Area of Cells on a Material Substrate
Additionally, note that the rest of Committee
F04 will meet during the November committee week on Nov. 18-21, in St. Louis, Mo. For meeting or membership information, contact Daniel Schultz (phone: 610-832-9716;
dschultz@astm.org). For more information on Committee F04, go to
http://www.astm.org/joinF04.html.
Release #8066/Sept08
