Overview
EN ISO 9917-1:2025 - Dentistry - Water-based cements - Part 1: Acid‑base cements specifies requirements and test methods for water‑based, acid‑base dental cements used for permanent cementation, lining and restoration. Applicable to both hand‑mixed and encapsulated (mechanically mixed) cements, the standard covers materials intended as luting agents, bases/liners, restorative materials and pit and fissure sealing cements. Resin‑modified water‑based cements are explicitly excluded. This edition supersedes the 2007 version and incorporates updated test methods and declaration requirements.
Key topics and technical requirements
EN ISO 9917-1:2025 defines classification, testing and information obligations. Major technical topics include:
- Scope and classification by chemical type and clinical application (luting, base/liner, restorative, pit and fissure sealant).
- Material composition: requirements for powder and liquid components and declarations of components supplied by manufacturers.
- Test methods and performance criteria, with normative annexes for:
- Net setting time (separate methods for general use and for pit & fissure sealing cements)
- Film thickness (for luting cements)
- Compressive strength
- Acid erosion resistance
- Optical properties for polyalkenoate restorative cements
- Acid‑soluble arsenic and lead content
- Radiopacity (adopts ISO 13116 test method if radiopacity is claimed)
- Packaging, marking and labeling: mandatory information to be supplied by the manufacturer, including component declaration and intended use.
- Annex structure (A–I) gives detailed, normative procedures for reproducible laboratory testing.
Practical applications and users
This standard is relevant to:
- Dental materials manufacturers - to design, test and declare acid‑base cements that meet European/ISO requirements.
- Quality control and materials testing laboratories - to perform and report standardized tests (setting time, compressive strength, radiopacity, etc.).
- Regulatory bodies and procurement teams - to assess compliance for market access, product specifications and tendering.
- Dental researchers and clinicians - to compare material performance and select appropriate luting, restorative or sealing cements.
- Standards bodies and certification organizations - for harmonized national adoption and conformity assessment.
Related standards
- ISO 13116 (radiopacity test method) - adopted in this edition
- ISO 10993-1 and ISO 7405 - recommended references for biological/toxicological assessment
- EN/CEN adoption context: published by CEN with identical text as ISO 9917-1:2025
Keywords: EN ISO 9917-1:2025, dentistry standard, acid‑base cements, water‑based cements, luting cements, restorative materials, pit and fissure sealing, compressive strength, film thickness, radiopacity, dental material testing.
