What is ANSI/ADA Standard No. 35 about?This standard specifies requirements and test methods for handpieces and motors used in dentistry. The standard applies to all dental handpieces, motors, and attachments involving rotary or reciprocating motion. This includes the following: straight and geared-angle handpieces and attachments, air and electrical motors, high speed air turbines, prophy handpieces and angles, and endodontic handpieces.
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Standard No. 35
What are the requirements I should know about for handpieces and motors?
This standard requires dental handpieces to be safe, reliable, simple to operate, comfortable to handle, and easy to clean and disassemble/reassemble. This includes provisions for usability such as: instrument surface finish, gripping surface, durability (drop test), prevention of unintentional activation, and compatible interfaces with dental units and rotary instruments (e.g. burs). There are also safety requirements such as those applicable to: electrical supply, air and water supplies, temperature rise during use, and noise output. Additionally, this standard specifies requirements and tests for handpiece performance, including: speed, eccentricity, and torque produced during use.
To ensure that handpieces will function adequately over long-term use, all requirements of the standard must be met after the handpiece is subjected up to 250 reprocessing cycles, including cleaning, disinfection, and sterilization.
What’s the bottom line?
ANSI/ADA Standard No. 35 establishes the requirements and test methods for essential safety and performance features of dental handpieces, as well as specifying required information to be provided by the manufacturer, including instructions for use, marking, and packaging. This ensures that a handpiece does not pose a risk to the operator or patient, is capable of adequately performing intended functions, and provides the necessary information for proper use and maintenance.