Overview
EN ISO 13017:2020 - Dentistry: Magnetic attachments (ISO 13017:2020) specifies requirements and test methods for evaluating dental magnetic attachments used to provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), implant superstructures, and orthodontic or maxillofacial prostheses including obturators. This European adoption of ISO 13017 (published July 2020) supersedes the 2012 edition and aligns manufacturer, laboratory and regulatory expectations for performance, safety and labelling of magnetic retention elements.
Key topics and requirements
- Scope and definitions: Terminology and intended uses for magnetic attachments in dentistry.
- Materials and composition: Requirements for magnet cores and non‑core components; manufacturers must report chemical composition including nickel content and permitted deviations.
- Hazardous elements: Identification of recognized hazardous elements and inclusion of cadmium, beryllium and lead limits (lead added in this edition).
- Magnetic performance: Tests for retentive force, device performance (single‑shaft retentive-force tester), measurement procedures and analysis - including specimen cleaning and fixation methods (e.g., cyanoacrylate adhesive, self‑curing acrylic resin) and a specified cross‑head speed for measurements.
- Magnetic flux leakage: Apparatus and procedure to assess stray magnetic fields.
- Corrosion resistance: Static immersion tests with quantitative analysis (limits of detection) and anodic polarization procedures to evaluate ion release and breakdown potential.
- Risk analysis, marking and labelling: Requirements for instructions for use, labelling (including quantity), and traceability information.
- References for biological assessment: For biocompatibility/toxicology, the standard refers users to ISO 10993‑1 and ISO 7405.
Practical applications
- Ensures consistent, reproducible evaluation of magnetic attachments used in:
- Overdentures and partial dentures
- Implant superstructures and crowns/bridges with magnetic retention
- Orthodontic and maxillofacial prostheses (obturators)
- Supports product development, quality control, and regulatory compliance by defining test methods for retentive force, corrosion resistance, and magnetic safety.
Who should use this standard
- Dental device manufacturers and R&D teams
- Dental laboratories and prosthodontic technicians
- Test laboratories performing materials and performance testing
- Regulatory bodies, procurement specialists and clinicians assessing device suitability
Related standards
Using EN ISO 13017:2020 helps ensure magnetic dental attachments meet recognized performance and safety expectations for clinical use.
