New ADA standards on dental cartridges, water quality available for review
Comments due June 10
Two proposed American National Standards Institute/American Dental Association standards are available for review and comment from the ADA Standards Program.
Proposed ANSI/ADA Standard No. 190, Dentistry — Single-Use Dental Cartridges for Local Anesthetics
This document gives specific performance requirements for single-use dental cartridges of 10-, 2.2-, 1.8- and 1.7-milliliter nominal capacity for use with local anesthetics. It specifies tests for leakage, plunger movement, extractable volume and underfilling and lists general overall dimensions to ensure the cartridge will fit dental cartridge syringes complying with ANSI/ADA Standard No. 34/ISO 9997 and ANSI/ADA Standard No. 183/ISO 21533. It also specifies labeling requirements. This proposed standard is a modified adoption of ISO 11499:2014 and will replace ANSI/ADA Standard No. 190:2020. “ISO” refers to the International Organization for Standardization.
Proposed ANSI/ADA Standard No. 207, Dentistry — Microbiological Quality of Dental Procedural Water — Requirements for Manufacturers
This document specifies manufacturer requirements regarding the control of microbiological quality of procedural water for nonsurgical dental procedures delivered by dental units and other devices. It applies to the following products:
• Devices that deliver procedural water, including, but not limited to, stationary dental units, mobile dental units, portable dental units, stand-alone ultrasonic scalers, stand-alone dental lasers and other stand-alone dental instrument systems.
• Products that are intended to control or improve the microbiological quality of dental procedural water, including, but not limited to, chemical formulations intended to be added to procedural water or administered intermittently to the procedural water system when patients are not being treated, as well as powered and nonpowered devices that are integrated within the dental unit or connected to the water supply to one or more dental units.
Informative Annex A in the document provides recommended best practices for the design and validation of devices that deliver dental procedural water and products that are intended to control or improve the microbiological quality of dental procedural water, consistent with current Centers for Disease Control and Prevention guidelines and Food and Drug Administration recommendations and requirements.
To obtain a copy of the draft documents, visit ADA.org/aipreview. Interested parties have until June 10 to comment.
The ADA is an ANSI-Accredited Standards Developer and has been at the forefront of the development of dental standards since 1928. These standards establish requirements for safe and effective dental products and technologies through a consensus-based process.
The ADA working groups that develop these standards include a diverse mix of expert volunteers representing dental practitioners, industry, government and academia. Involvement is open to anyone who would like to contribute their expertise.
To learn more about the standards program, visit ADA.org/dentalstandards.
