CHICAGO--The American Dental Association Standards Committee on Dental Products has published a major revision of ADA Specification No. 41, "Recommended Standard Practices for Biological Evaluation of Dental Materials."
This specification, recently approved by the American National Standards Institute as an American National Standard, is its first revision since 1979. Expanded and updated, the revised edition provides detailed guidelines and methodologies for dental professionals, scientists and manufacturers who must evaluate the biocompatibility of dental materials as part of a materials research or evaluation program.
Biological evaluations of dental materials are performed to determine the potential toxicity resulting from contact of the component materials with the body. Evaluation of any new dental materials intended for human use requires data from systematic biocompatibility testing to ensure that the benefits provided by the final product will exceed any potential risks by the materials.
This is why one of the most important objectives of the ADA standards program is to provide updated guidelines, developed by a consensus committee of experts, on appropriate biocompatibility tests. The new edition was in development for several years and includes many new tests, with detailed procedures and guidelines for interpretation of results that were not previously available.
In the new revision, the tests are divided into three groups. Group 1 comprises in vitro tests of cytotoxicity.
Group II tests are in vivo tests, including acute systemic toxicity (oral and inhalation), subchronic systemic toxicity (oral and inhalation), skin irritation and intracutaneous reactivity, sensitization, genotoxicity and local effects after implantation.
Group III comprises dental materials-specific tests such as pulp and dentin usage, pulp capping and endodontic usage. Detailed protocols for methods appropriate to dental materials in all three categories are included in the new, 202-p. standard.
Other sections provide guidelines on selection of tests, sample preparation, use of animal and human subjects and reporting of results.
ANSI/ADA Specification No. 41 and all ANSI/ADA Specifications, ADA Technical Reports and ISO Standards are available for download or hard copy purchase from the ADA E-catalog at www.adacatalog.org or by calling (800) 947-4746. Callers from abroad should call (312) 440-2500.
Any questions regarding the standards section of the ADA E-catalog or the purchasing of standards should be made via e-mail to [email protected].
