Overview
ISO 9917-2:2017 - "Dentistry - Water-based cements - Part 2: Resin‑modified cements" specifies requirements and test methods for water-based dental cements that set by a combination of an acid–base reaction and polymerization. The standard covers materials used for luting, base or lining, restoration, and tooth core build‑up, and harmonizes test procedures with related standards where possible.
Key topics and technical requirements
- Scope and classification
- Applies to cements that set by both an aqueous acid–base reaction and polymerization.
- Classification by polymerization activation:
- Class 1: polymerization activated after mixing
- Class 2: light‑activated polymerization
- Class 3: dual activation (mixing and light)
- Mandatory tests and annexes
- Working time and setting time (Annex A)
- Film thickness for luting materials (Annex B)
- Flexural strength (Annex C)
- Radio‑opacity (Annex D; aligns with ISO 13116)
- Shade and colour stability for restorative materials (Annex E; ISO 7491 referenced)
- Selected quantitative requirements (Table 1 examples)
- Luting: film thickness ≤ 25 µm; working time ≥ 1.5 min; setting time ≤ 8 min; flexural strength ≥ 10 MPa
- Restoration: working time ≥ 1.5 min; setting time ≤ 6 min; flexural strength ≥ 25 MPa
- Film thickness shall not exceed manufacturer claim by more than 5 µm
- Radio‑opacity: at least equal to same thickness of aluminium if claimed
- Colour stability: no more than a slight change after 7 days (when tested to ISO 7491)
- Test conditions
- Standardized environment: (23 ± 2) °C and relative humidity (50 ± 20) %
- Use water per ISO 3696 (grade 2)
- Packaging and labelling
- Requirements for sealed containers, outer pack, instructions for use, and manufacturer claims
Practical applications - who uses ISO 9917-2:2017
- Dental materials manufacturers - develop and validate resin‑modified glass ionomer products to meet performance claims and labeling requirements.
- Independent test laboratories - perform standardized testing (working/setting time, flexural strength, radio‑opacity, film thickness, colour stability).
- Regulatory bodies and procurement - assess conformity and comparative performance for approval or purchasing.
- Clinical researchers and dental professionals - interpret material data sheets and select materials for specific clinical uses (luting, lining, restoration, core build‑up).
Related standards
For product development, testing or compliance checks involving resin‑modified dental cements, consult the full ISO 9917‑2:2017 document for detailed procedures, sampling plans and normative requirements.