ISO 13017:2020 PDF

Overview

ISO 13017:2020 - "Dentistry - Magnetic attachments" specifies requirements and test methods for dental magnetic attachments used to provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures, overdentures), implant superstructures, and orthodontic or maxillofacial prostheses including obturators. The standard defines material, safety and performance criteria, preparation and test procedures (retentive force, magnetic flux leakage, corrosion resistance), and requirements for information, marking and labelling.

Key Topics and Requirements

• Materials and composition
  • Magnet cores must be classified by principal constituents per IEC 60404-8-1.
  • Manufacturers must declare chemical composition for non-magnet components; elements >1.0% (mass fraction) must be reported.
• Hazardous elements
  • Nickel, cadmium, beryllium and lead are designated hazardous.
  • Cadmium, beryllium and lead are limited to ≤ 0.02% (mass fraction) as determined by ISO 22674.
  • If nickel >0.1% is present, the manufacturer must report content with 0.1% accuracy.
• Performance tests
  • Retentive force: detailed specimen preparation, fixing procedures, and measurement method (including cross-head speed specification) to quantify retention and moving friction.
  • Magnetic flux leakage: apparatus and procedures to assess stray magnetic fields.
  • Corrosion resistance: static immersion tests and anodic polarization to measure released ions and breakdown potential.
• Risk analysis, labelling and instructions
  • Requirements for risk analysis, user information, marking and labelling (including quantity) to support safe clinical use.
• Traceability and documentation
  • Manufacturer disclosure obligations for composition and lot production information on request.

Applications

ISO 13017:2020 is applied where reliable magnetic retention and biocompatible, corrosion-resistant performance are required:

• Overdentures and partial denture retention systems
• Implant-supported magnetic superstructures
• Orthodontic and maxillofacial prostheses (including obturators)
• Design validation, quality control and regulatory submissions for dental magnetic attachments

Who uses this standard

• Dental device manufacturers and product designers
• Prosthodontists and clinical teams specifying magnetic retention systems
• Dental laboratories and implant component suppliers
• Test laboratories performing mechanical and corrosion testing
• Regulatory bodies and conformity assessors

Related Standards

• ISO 10993-1, ISO 7405 (biological/toxicological assessment guidance)
• IEC 60404-8-1 (magnet classification)
• ISO 22674, ISO 10271, ISO 14233, ISO 1942, ISO 15223-1 (materials, corrosion, labelling and terminology)

Keywords: ISO 13017:2020, dental magnetic attachments, dentistry standard, retentive force, corrosion resistance, hazardous elements, magnetic flux leakage.