Overview
EN ISO 19023:2018 - Dentistry - Orthodontic anchor screws (ISO 19023:2018) specifies requirements and test methods for orthodontic anchor screws (temporary intraoral skeletal anchorage devices). The standard defines how to compare physical and mechanical properties, and it gives packaging, labelling and information-to-user requirements to support clear communication between manufacturers, clinicians and testing laboratories. Note: these screws are temporary and are removed at the end of orthodontic treatment.
Key Topics and Technical Requirements
- Materials
- Acceptable materials reference ISO 5832‑2, ISO 5832‑3, ASTM F67 or ASTM F136. If other alloys are used, the manufacturer must declare composition components present ≥ 0.1% by mass.
- Hazardous elements
- Cadmium, beryllium, lead and nickel are designated hazardous; manufacturers shall state their concentrations (mass fraction %).
- Dimensions and tolerances
- Important dimensions (thread diameters, shaft length, neck height, head height, overall length) must be declared and measured to an accuracy of 0.05 mm (Clause 6.1).
- Torsional performance
- Fracture torque and insertion torque under worst‑case conditions must be specified. Fracture torque is tested per ASTM F543‑17 (test method A1) with a minimum of five specimens (Clause 6.2). Insertion torque is measured using a synthetic bone analogue (e.g., highest density Sawbones per ASTM F‑1839‑08) to simulate maximum bone density (Clause 6.3).
- Reporting and compliance
- Test results for each specimen must lie within the manufacturer’s declared ranges/tolerances for compliance (Clause 5.6).
- Information to user, labelling and packaging
- Requirements cover instructions for use, labelling content and packaging to ensure safe insertion/removal and identification (Clause 7).
Applications and Who Uses This Standard
- Manufacturers - to design, test and declare material, dimensional and mechanical properties of orthodontic anchor screws for market access and product data sheets.
- Clinical users (orthodontists, oral surgeons) - to compare products using standardized metrics (insertion torque, fracture torque, dimensions) for treatment planning and device selection.
- Testing laboratories and conformity assessors - to perform dimensional and torsional tests in a standardized manner.
- Regulators and procurement teams - to specify requirements in tenders, certificates and technical files.
Related Standards
- ISO 5832‑2, ISO 5832‑3 (implant materials)
- ASTM F67, ASTM F136 (titanium specifications)
- ASTM F543‑17 (bone screw test methods)
- ASTM F‑1839‑08 (synthetic bone)
- ISO 10993‑1, ISO 7405 (biological/toxicological assessment - recommended references)
Keywords: EN ISO 19023:2018, orthodontic anchor screws, temporary skeletal anchorage, torsional performance, insertion torque, fracture torque, dental materials, packaging and labelling.