Air-Powered Dental Handpieces and Motors - Performance Testing and Safety Requirements
This guidance covers air-powered dental handpieces and air motors (Class I reserved devices) with metal construction, maximum speed of 450,000 RPM, and intended for end-user sterilization. The devices are used in general dentistry for cutting/grinding teeth, cavity preparations, crown preparations, and finishing/trimming. The guidance excludes devices with non-metallic materials, electrical/battery components, prophy handpieces, bone cutting instruments, ultrasonic scalers, single-use devices, and devices not intended for user sterilization.
Recommended Actions
- Conduct comprehensive mechanical bench testing according to ISO 14457
- Perform usability evaluation following IEC 62366-1
- Complete biocompatibility testing for the three required endpoints
- Validate reprocessing procedures for 250 cycles
- Prepare detailed test reports and Declarations of Conformity
- Ensure clear labeling and instructions for use including reprocessing
- Verify compliance with all dimensional and performance specifications
- Document all test results in the format specified by FDA guidance
- Consider Pre-Submission if additional testing might be necessary
- Prepare comprehensive cleaning and sterilization validation documentation
Key Considerations
Non-clinical testing
- Drop test according to ISO 14457
- Noise level testing (should not exceed 80 dB)
- Surface testing
- Air supply testing (flow rate < 80 NL/min at 300 ± 100 kPa)
- Water supply testing (if applicable)
- Air and water pressure testing
- Leakage testing
- Speed testing (within ±10% of specified)
- Eccentricity testing
- Stall torque testing (if applicable)
- Resistance to 250 reprocessing cycles
Human Factors
- Usability evaluation according to IEC 62366-1
Labelling
- Operating controls should use graphical symbols according to ISO 9687
- Clear reprocessing instructions including recommended cleaning agents
Biocompatibility
- Cytotoxicity testing
- Sensitization testing
- Oral Mucous Irritation testing
Safety
- Operating controls design to minimize accidental activation
- Connection safety requirements according to ISO 9168 and ISO 3964
- Chuck system safety requirements for holding rotary instruments
Other considerations
- Reprocessing validation according to relevant standards
- Light functionality testing (if applicable)
- Dimensions compliance
Relevant Guidances
- Dental Handpieces - Performance Testing, Safety Requirements and Labeling
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms
- ISO 14457: Dentistry – Handpieces and motors
- ISO 9687: Dentistry – Graphical symbols for dental equipment
- IEC 62366-1: Medical devices — Application of usability engineering to medical devices
- ISO 9168: Dentistry — Hose connectors for air driven dental handpieces
- ISO 3964: Dentistry – Coupling dimensions for handpiece connectors
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 7405: Dentistry – Evaluation of biocompatibility of medical devices used in dentistry
Original guidance
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