CHICAGO--American Dental Association Specification No. 41, Recommended Standard Practices for Biological Evaluation of Dental Materials, has undergone its first revision since 1979.
Approved by the American National Standards Institute as an American National Standard and published by the ADA Standards Committee on Dental Products, this greatly expanded and updated edition is designed to provide detailed guidelines and methodologies for dental professionals, scientists and manufacturers to 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 require data from systematic biocompatibility testing to ensure that the benefits provided by the final product will exceed any potential risks by the materials.
The new revision provides tests 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 this 202 page specification.
When possible, alternative tests are provided as options to better suit different types of products. This specification also provides guidelines on test selection, sample preparation, use of animal and human subjects and reporting of results.
In development for several years, ADA Specification No. 41, includes many new tests with detailed procedures and guidelines for interpretation of results that were not previously available.
ANSI/ADA Specification No. 41 and all ADA specifications and technical reports are available 24 hours a day, 7 days a week for download or hard copy purchase at www.adacatalog.org or by calling (800) 947-4746.
Callers from abroad should call (312) 440-2500. Any general standards questions should be sent to [email protected].
