Overview
EN ISO 20569:2018 - Dentistry - Trephine burs (ISO 20569:2018) specifies requirements and test methods for dental trephine burs used primarily in oral implantology for collecting bone cores and removing implants. Published by CEN/ISO, the standard covers design classification, material selection, dimensional tolerances, performance tests, and requirements for marking, labelling and instructions for use. It helps manufacturers, test laboratories and dental clinics ensure safety, interchangeability and reprocessing compatibility of trephine burs.
Key Topics and Requirements
- Scope and classification
- Defines two types: Type 1 (for bone collection) and Type 2 (for implant removal).
- Materials
- Metals shall comply with ISO 7153-1 and ISO 13504 (surgical/dental instrument material requirements).
- Dimensions and tolerances
- Type 1 outer working-part diameter (D1): 2 mm to 16 mm.
- Type 2 inner working-part diameter (D2): 2 mm to 15 mm.
- Manufacturer’s stated values must be within ±0.05 mm (measured per clause 6.2).
- Wall thickness is manufacturer-defined but must withstand specified torque.
- Mechanical performance
- Resistance to torque: trephine burs must withstand 80 N·cm (test method in clause 6.6).
- Tests include Vickers hardness, run-out, and resistance to reprocessing.
- Surface, marking and labelling
- Surface finish: free of visible defects (visual inspection per clause 6.1).
- Marking lines, shank dimensions and package labelling are specified; instructions for reprocessing must follow ISO 17664.
- Test methods
- Referenced test methods include ISO 8325 (rotary instruments) and ISO 6507-1 (Vickers hardness) among others.
Applications and Who Uses This Standard
- Practical uses:
- Standardizes trephine burs used for bone harvesting, implant removal, and other implantology procedures.
- Ensures devices are dimensionally accurate, mechanically safe and reprocessable.
- Primary users:
- Manufacturers designing and certifying trephine burs.
- Quality and testing laboratories performing conformity tests (hardness, run-out, torque).
- Regulatory bodies and procurement teams assessing device compliance.
- Dental surgeons and clinics seeking validated instruments and processing instructions.
- Sterilization/reprocessing personnel relying on manufacturer-provided processing data.
Related Standards
Keywords: EN ISO 20569:2018, ISO 20569, trephine burs, dentistry, oral implantology, bone collection, implant removal, dental instrument standards, marking and labelling.