Overview
ISO 20569:2018 specifies requirements and test methods for trephine burs used in dentistry, particularly in oral implantology procedures such as collecting bone cores and removing implants. The standard covers design classification, materials, dimensional tolerances, mechanical performance (hardness, run-out, torque), reprocessing resilience, and requirements for marking and labelling so clinicians can use devices safely and reliably.
Key topics and technical requirements
- Classification:
- Type 1 - for bone collection (outer-diameter specified).
- Type 2 - for implant removal (inner-diameter specified).
- Materials and surface:
- Metals to conform with ISO 7153‑1 and ISO 13504.
- Surfaces must be free of visible defects on visual inspection.
- Dimensions and tolerances:
- Type 1 outer working diameter: 2 mm to 16 mm.
- Type 2 inner working diameter: 2 mm to 15 mm.
- Diameter tolerance: ±0.05 mm (measured per ISO 8325).
- Operative part length tolerance: ±0.5 mm.
- Shank dimensions per ISO 1797.
- Marking and labelling:
- Depth marking lines from tip; legible without magnification and within ±0.1 mm of stated dimensions.
- Diameter value must be marked (Type 1 outer, Type 2 inner) on operative part or shank.
- Manufacturer must provide reprocessing/sterilization instructions (ISO 17664).
- Mechanical performance:
- Vickers hardness ≥ 500 HV2 (ISO 6507‑1).
- Run-out ≤ 0.1 mm (measured near the tip).
- Resistance to torque: 80 Ncm without fracture or deformation - tested after reprocessing.
- Reprocessing:
- Validation for at least 10 reprocessing cycles (or manufacturer's declared maximum), including cleaning, disinfection and sterilization per ISO 17664; no deterioration allowed.
Applications and users
- Practical uses: design, manufacture and quality control of dental trephine burs for bone harvesting and implant removal; acceptance testing; clinical procurement decisions.
- Primary users: medical device manufacturers, R&D and design engineers, quality assurance and test laboratories, dental clinics and oral surgeons, regulatory and purchasing specialists who require compliance evidence for implantology instruments.
Related standards
Keywords: ISO 20569, trephine burs, dental trephine, oral implantology, Vickers hardness, run-out, torque resistance, reprocessing, dental instruments, marking and labelling.