Overview
ISO 9917-1:2025 - Dentistry - Water‑based cements - Part 1: Acid‑base cements specifies requirements and test methods for acid‑base, water‑based dental cements used for permanent cementation, lining and restoration. The third edition applies to both hand‑mixed and encapsulated cements intended for mechanical mixing and excludes resin‑modified water‑based and non‑acid‑base materials (e.g., calcium silicate–based cements). It defines limits and test procedures according to the intended application: luting agent, base/liner, restorative material or pit and fissure sealing cement.
Key topics and technical requirements
ISO 9917-1:2025 covers material, classification, testing and information that manufacturers and test labs must provide. Major technical topics include:
- Classification by chemical type (e.g., zinc phosphate, zinc polycarboxylate, glass polyalkenoate) and by application (luting, base/liner, restorative, pit & fissure sealing).
- Material requirements for powder and liquid components and for the unset mixed cement (homogeneity, absence of deposits).
- Test methods and limits for properties such as:
- Net setting time (separate methods for general use and pit & fissure sealing)
- Film thickness (for luting cements)
- Compressive strength
- Acid erosion
- Optical properties (polyalkenoate restorative cements)
- Acid‑soluble arsenic and lead contents
- Radiopacity (if the manufacturer claims it)
- Sampling, preparation and ambient conditions for test specimens (23 ±1 °C; 50 ±10 % RH) and specified mixing procedures.
- Packaging, marking and labelling requirements, including a declaration of components and information the manufacturer must supply.
Normative annexes (A–I) provide step‑by‑step test procedures for all referenced measurements (e.g., net setting time, film thickness, radiopacity).
Applications and users
Who uses ISO 9917-1:2025:
- Dental product manufacturers - to design, test and certify acid‑base cements for specific clinical uses.
- Test laboratories and quality control teams - to perform standardized measurements and compliance testing.
- Regulatory bodies and conformity assessors - to evaluate product safety, labelling and performance claims.
- Dental researchers and R&D - for comparative testing and material development.
- Procurement and clinicians - to understand performance claims (e.g., setting time, compressive strength, radiopacity) when selecting cements.
Related standards
Using ISO 9917-1:2025 helps ensure consistent, testable performance of acid‑base dental cements and supports regulatory compliance, product claims and clinical reliability.
