EN ISO 17509:2016 PDF

Overview

EN ISO 17509:2016 - "Dentistry - Torque transmitter for handpieces (ISO 17509:2016)" specifies safety and performance requirements for torque transmitters used in oral implantology as accessories to dental handpieces. The standard covers classification, intended performance, material selection, dimensions, performance evaluation, manufacture, reprocessing resistance and the information manufacturers must supply. It applies to torque transmitters used for placement and removal in the oral cavity that connect to power‑driven systems with torque control, but it does not apply to the power‑driven systems themselves nor to dental implants or implant parts.

Key Topics and Requirements

• Scope & exclusions: Applies only to torque transmitters (accessories), not to implants or the power-driven handpiece systems.
• Classification: Aligned with ISO 13504 - Type 1 (energized/motor‑driven), Tissue contact Class 3 (without tissue contact), Reprocessing Group 1 (multiple use).
• Dimensions and interfacing:
  • Shank dimensions and tolerances must follow ISO 1797‑1 Type 1 shank.
  • Manufacturers must label the shape and dimensions of the engaging part that fits implant bodies or connecting parts.
• Performance:
  • Torque transmitters shall transmit at least 0.8 N·m for implant insertion.
  • Stall torque testing procedures and apparatus are defined (chuck per ISO 1797‑1; torque measuring device with accuracy ±10%).
• Materials & hardness:
  • Material selection per ISO 13504 requirements; steel shanks hardness ≥ 500 HV5 (Vickers).
• Reprocessing:
  • Multiple‑use instruments must withstand 100 reprocessing cycles (cleaning, disinfection, sterilization) without performance loss or corrosion.
• Manufacturer information:
  • Product marking (manufacturer/trademark) and technical data in the product file; instructions for use and reprocessing guidance required.
• Usability & safety: Usability engineering per IEC 62366‑1 and general dental instrument requirements from ISO 13504.

Applications and Who Uses It

• Dental device manufacturers designing torque transmitters and handpiece accessories for oral implantology.
• Quality, regulatory and design engineers ensuring compliance with EU/CEN and ISO requirements for dental accessories.
• Clinical procurement and sterilization teams verifying reprocessing compatibility and labeling.
• Test labs and conformity assessors performing dimensional, hardness and stall torque testing.

This standard is essential for ensuring reliable torque transmission, device compatibility with implant interfaces, and safe reprocessing practices in dental implant procedures.

Related Standards

• ISO 13504 (general dental implant instrument requirements)
• ISO 1797‑1 (shank dimensions)
• ISO 6507‑1 (Vickers hardness test)
• IEC 62366‑1 (usability engineering)
• ISO 16443, ISO 3274, ISO 4288 (referenced for vocabulary and surface texture)