New dental products standards projects announced; review sought
The ADA has played a key role in the development of dental standards since 1928 and is an American National Standards Institute accredited standards developer.
The projects are:
• Proposed ANSI/ADA Standard No. 57 on Endodontic Sealing Materials will be a modified adoption of ISO 6876:2012 Root Canal Sealing Materials and will revise and replace the current ADA Standard No. 57:2000 (R2012) Endodontic Sealing Materials. The revision is for materials used in endodontics within the tooth to seal the root canal space with the aid of obturating points/cones.
• Proposed ANSI/ADA Standard No. 128 Hydrocolloid Impression Materials will be an identical adoption of ISO 21563:2013 of the same name. This standard specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes.
• Proposed ANSI/ADA Standard No. 149 tabletop dry heat (heated air) sterilization and sterility assurance in health care facilities will be an identical adoption of ANSI/AAMI ST40:2004 (R2010) of the same name, a standard written by the Association for the Advancement of Medical Instrumentation. Both ANSI and AAMI approved this standard, which provides guidelines for decontamination and dry heat sterilization procedures used in dentists' and physicians' offices, laboratories, ambulatory care clinics and other health care facilities.
These guidelines are intended to promote the assurance of sterility by identifying the special considerations that apply to this method of sterilization and by providing recommendations on the proper use of tabletop dry heat sterilization processing equipment. This recommended practice also covers facility design considerations, personnel considerations, work practices and other variables that affect sterility assurance.
This work project will establish a joint ANSI/ADA/AAMI standard.
Additionally, the Council on Scientific Affairs and the Standards Committee on Dental Products have approved circulation of the following draft standards for review and comment:
• Proposed ANSI/ADA Standard No. 132 Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems describes test methods used to evaluate the repeatability, reproducibility and accuracy of dental devices for 3-D metrology. The standard is applicable to dental chairside and dental laboratory computer-aided design/computer-aided manufacturing systems. The scope of this document is not intended to include unique systems with other specific applications of 3-D metrology in the dental field, such as 3-D computed tomography, magnetic resonance imaging and stereophotogrammetry.
• Proposed ANSI/ADA Standard No. 137 Essential Characteristics of Test Methods for the Evaluation of Treatment Methods Intended to Improve or Maintain the Microbiological Quality of Dental Unit Procedural Water is an identical adoption of ISO/TS 11080:2009 of the same name. This standard provides guidelines for type test methods for evaluating the effectiveness of treatment methods intended to improve or maintain the microbiological quality of procedural water from dental units and other dental equipment under laboratory conditions.
The working groups that develop ADA standards are a diverse group of expert volunteers representing dental practitioners, industry, government and academia. Professionals from all areas of interest may participate. Additionally, the Working Groups on Investments and Portable Dental Units seek additional members to participate on projects.
Volunteers contribute their expertise on documents that establish requirements for safe and effective dental products and technologies through a consensus-based process. Involvement is open to anyone who would like to contribute expertise anywhere from the initial planning phase through reviewing final drafts.
For more information or to participate in any of the projects, call ext. 2506, or email firstname.lastname@example.org.
To learn more about standards, visit ada.org/dentalstandards.