EN ISO 3107:2022 PDF

Overview

EN ISO 3107:2022 (Dentistry - Zinc oxide‑eugenol cements and non‑eugenol zinc oxide cements) defines performance, sampling and test methods for zinc oxide–eugenol cements and non‑eugenol zinc oxide cements used in restorative dentistry. The standard covers materials intended for temporary cementation, as bases, and as temporary restorations, and it supersedes EN ISO 3107:2011.

Key topics and technical requirements

• Scope and classification
  • Two product types based on intended use: Type I (temporary cementation) and Type II (bases and temporary restorations).
• Performance metrics
  • The standard sets numeric performance limits for critical properties, including setting time (measured at 37 °C), compressive strength, film thickness, and acid‑soluble arsenic content. (Example values appear in Table 1 of the standard-see EN ISO 3107:2022 for the full table.)
• Test methods and specimen preparation
  • Specimens are prepared per the manufacturer’s instructions and tested under controlled ambient conditions: (23 ± 2) °C and (50 ± 5) % RH.
  • Setting‑time tests are conducted in a cabinet at (37 ± 1) °C and (95 ± 5) % RH using defined indenter apparatus.
  • Other specified methods include compressive strength, film thickness, and arsenic fraction determinations with referenced analytical procedures.
• Sampling and packaging
  • Test samples should be representative retail packages from the same batch (recommendation: ~50 g to allow repeats).
  • Marking, labelling and instructions for use are required; packaging and labelling rules are specified in Clause 8.
• Biocompatibility guidance
  • For biological safety assessment the standard refers to ISO 10993‑1 and ISO 7405.

Practical applications and users

• Manufacturers of dental cements use EN ISO 3107:2022 to design, test and declare compliance for market access in CEN/ISO regions.
• Regulatory authorities and notified bodies rely on the standard during product evaluation and conformity assessment.
• Dental laboratories and clinicians consult the standard to understand expected material performance for temporary cementation and restorative procedures.
• Procurement and quality teams use the standard to specify material acceptance criteria (setting time, strength, film thickness, safety limits).

Related standards

• ISO 10993‑1 - Biological evaluation of medical devices
• ISO 7405 - Dentistry - Evaluation of biocompatibility
• ISO 1942 - Dentistry vocabulary
• ISO 2590 - Arsenic determination methods

For exact numeric limits, test apparatus specifications and full procedural details consult the official EN ISO 3107:2022 text. Keywords: EN ISO 3107:2022, zinc oxide‑eugenol cement, non‑eugenol zinc oxide cement, temporary cementation, dental materials standard.