Overview
EN ISO 20795-2:2013 - Dentistry: Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013) sets out requirements and test methods for orthodontic base polymers and copolymers used in removable active and passive orthodontic appliances. Prepared by ISO/TC 106 in collaboration with CEN, the standard defines material classification, processing and inspection criteria, laboratory specimen preparation, testing procedures, and requirements for packaging, marking and instructions for use.
Key topics and technical requirements
- Scope and classification - Covers three material types: autopolymerizable, light‑activated, and thermoplastic orthodontic base polymers.
- Unpolymerized material - Requirements for liquid (monomer) and solid (powder) components, including homogeneity and freedom from visible contamination.
- Polymerized material properties - Surface finish (smooth, hard, glossy), shape capability, colour stability and even pigmentation when coloured.
- Mechanical and physical tests - Standard specifies methods for:
- Polishability, porosity, flexural strength and flexural modulus
- Fracture toughness (modified bending test)
- Residual methyl methacrylate (MMA) monomer content (including an HPLC method in Annex A)
- Plasticiser content (where applicable)
- Water sorption and solubility
- Sampling and specimen preparation - Detailed laboratory conditions and procedures for making test specimens to ensure reproducible results.
- Packaging, marking and instructions - Requirements for outer packaging, immediate containers, labelling and user instructions to support safe and effective use.
Practical applications and users
EN ISO 20795-2:2013 is used by:
- Dental materials manufacturers for product development, quality control and conformity assessment of orthodontic base polymers.
- Orthodontic and dental laboratories to select and process materials consistent with standardized performance expectations.
- Testing laboratories to perform accredited mechanical, chemical and physical testing (e.g., residual monomer by HPLC, water sorption).
- Regulatory and procurement bodies assessing product documentation, labelling and compliance.
- Clinicians and dental technicians seeking assurance about material behaviour (polishability, dimensional stability, residual monomer risk) for removable orthodontic appliances.
Related standards
EN ISO 20795-2:2013 provides a practical, test‑driven framework for ensuring that orthodontic base polymers meet consistent performance, safety and labelling expectations across manufacturing and clinical use.
