• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

NIST Working Meeting on Standards Emphasizes Components of Combination Tissue Engineered Products

Reprinted with permission, Society for Biomaterials, copyright 1998:

by Grace Lee Picciolo - past Chair, Tissue Engineered Products Special Interest Group and
Arthur C. Coury - Chair, Devices and Materials Committee

Needs have been established and invitations are out to enlist the Society members in the development of standards for Tissue Engineered products through the American Society for Testing and Materials committee F04 on Medical and Surgical Materials and Devices, chaired by Jack Lemons. A new division IV has been tentatively established to develop private sector national consensus standards for the components of combination Tissue Engineered medical products.

The Biomaterials Standards subcommittee of the Society For Biomaterials Devices and Materials Committee encourages and supports the development of reference biomaterials. This Subcommittee is collaborating with the Tissue Engineered Products Special Interest Group in the area of standards for tissue engineered products. Contributing to the development of ASTM standards is a valuable way for the Society members to advance this process.

The Tissue Engineered Products Special Interest Group is developing a voluntary guidance/standard for products containing living cells. Under the leadership of Dan Omstead and Frank Gentile, contributors are formulating an approach to the standardization of components of these products.

The Workshop on the same subject at the May, 1997 ASTM meeting highlighted the role of ASTM in Tissue Engineering and subsequent Initiation meeting in San Diego, November 1997 developed the plan for standards activities under the leadership of Peter Johnson of the Pittsburgh Tissue Engineering Initiative. An important follow-up working meeting will be held at the National Institutes of Standards and Technology in Gaithersburg, MD on Tuesday, Dec 16, 1997 from 9:30 am to 4:00 pm. ADDITIONAL INFORMATION AND REGISTRATION INFORMATION CAN BE OBTAINED FROM ASTM BY CONTACTING ANNE RICHTER AT 610-832-9689 OR arichter@astm.org.

Components of tissue engineered products such as cells, cellular products, biomolecules, synthetic and natural materials will be addressed as candidates for the development of standardization protocols and reference materials.

Scientific, technical, regulatory and industrial individuals and groups who are stake holders in the products development are encouraged to participate in the effort.

For comments on the Tissue Engineered Medical Products Standards contact the site coordinator: PiccioloGrace@mail-me.com