ISO 22112:2017

Overview

ISO 22112:2017 - Dentistry - Artificial teeth for dental prostheses specifies classification, requirements, and test methods for industrially manufactured artificial teeth (ceramic and polymer) intended for use in dental prostheses. Published in 2017, the standard sets out essential attributes - from biocompatibility and dimensional tolerances to colour matching, surface finish, defect limits and lab test procedures - to ensure safety, performance and interchangeability of denture teeth.

Key Topics

The standard addresses technical and quality requirements including:

• Classification of artificial teeth by material type (ceramic, polymer) and intended use.
• General requirements: biocompatibility, dimensional specifications, shade/blending, surface finish, porosity and visual defects.
• Ceramic-specific requirements: radioactivity limits, anchorage design for attachment to denture base, resistance to thermal shock.
• Polymer-specific requirements: bonding to denture-base polymers, resistance to blanching/distortion/crazing, colour stability, dimensional stability.
• Sampling, measurement and test methods: visual inspection, dimensional measurement, shade comparison, surface finish and porosity tests, radioactivity counting, anchorage and bond strength tests, thermal shock and conditioning procedures.
• Manufacturer information, marking and packaging: mould charts, shade guides, instructions for use, labelling and packaging requirements.

Applications

ISO 22112 is practical for:

• Manufacturers of artificial teeth who need to design, test and certify products to recognized quality and safety criteria.
• Dental laboratories and prosthetists performing incoming inspection, quality control and specifying teeth for removable prostheses.
• Regulatory and conformity assessment bodies evaluating product documentation and test reports.
• Procurement managers and clinicians who require standardised specifications for compatibility, shade matching and long-term performance.
• R&D and QA teams using the standard’s test methods for product development, validation and batch acceptance.

Practical uses include defining product specifications, creating inspection protocols, preparing regulatory dossiers, and ensuring predictable aesthetics and mechanical behaviour in dentures.

Related standards

ISO 22112 supplements other dentistry and materials standards (biocompatibility and dental-material testing) and follows ISO/IEC directives for standard development. For implementation, consult ISO’s catalogue or relevant national standards bodies for cross-references and harmonized dental-material standards.

For authoritative text and purchasing, refer to ISO (www.iso.org) or your national ISO member body.