Overview
EN ISO 9917-2:2017 - "Dentistry - Water-based cements - Part 2: Resin-modified cements" (CEN adoption of ISO 9917-2:2017) sets out requirements and test methods for water‑based dental cements that harden by a combination of an aqueous acid–base reaction and polymerization. It applies to materials intended for luting, base/lining, restoration and tooth core build‑up, and is the authoritative standard for evaluating resin‑modified glass‑ionomer and related cements.
Key topics and technical requirements
- Scope and classification
- Defines three classes based on how the polymerization component is activated:
- Class 1: chemical activation after mixing
- Class 2: light‑activated polymerization
- Class 3: dual‑cure (chemical and light)
- Performance requirements and tests (normative)
- Working time and setting time - methods for measuring manipulable and final set periods
- Film thickness - specific test for luting materials
- Flexural strength - mechanical performance for restorative function
- Radio‑opacity - measured using ISO 13116 procedures
- Shade and colour stability - for restorative (and some luting) materials
- Sampling, specimen preparation and test conditions - standardized procedures for reproducible testing
- Packaging, marking and instructions for use - required information for manufacturers and users
- Normative annexes provide step‑by‑step test methods (working/setting time, film thickness, flexural strength, radio‑opacity, colour stability)
NOTE: The standard harmonizes many test methods with related standards (ISO 4049 and ISO 9917‑1) and advises referring to ISO 10993‑1 and ISO 7405 for biological/toxicological assessment.
Practical applications
- Product development and formulation of resin‑modified glass ionomer cements and similar water‑based dental materials
- Quality control and type testing in manufacturing - to verify working time, strength and radio‑opacity
- Test laboratories performing standardized mechanical, optical and radiographic evaluations
- Regulatory compliance and technical documentation for market approval in Europe and internationally
- Clinical procurement and dental practice evaluation - helping clinicians choose materials suited to luting, lining, restoration or core build‑up
Who should use this standard
- Dental materials manufacturers
- Clinical researchers and product developers
- Independent testing laboratories and conformity assessment bodies
- Regulatory authorities and Notified Bodies assessing dental device compliance
- Dental professionals seeking validated performance data for materials selection
Related standards to consider: ISO 9917‑1, ISO 4049, ISO 13116, ISO 10993‑1 and ISO 7405.