ISO 3107:2022

Overview

ISO 3107:2022 - Dentistry - Zinc oxide‑eugenol cements and non‑eugenol zinc oxide cements specifies performance, test methods and labelling for zinc‑oxide based cements used in restorative dentistry. The standard covers cements intended for temporary cementation, for use as bases and as temporary restorations, and also addresses non‑eugenol variants that use oils other than eugenol.

Key topics and technical requirements

• Classification
  • Type I: for temporary cementation
  • Type II: for bases and temporary restorations
• Performance limits (selected highlights from Table 1)
  • Setting time (at 37 °C): 1.5 to 10 min (both types)
  • Compressive strength: Type I ≥ 35 MPa; Type II ≥ 5 MPa
  • Film thickness: Type I ≤ 25 µm (Type II not applicable)
  • Acid‑soluble arsenic (24 h): ≤ 2 mg/kg
• Test methods and specimen preparation
  • Ambient conditions for preparation: (23 ± 2) °C, 50 ± 5% RH
  • Setting‑time determination: specimens conditioned at 37 ± 1 °C, with specified indenters (Type I: 100 g, 2.0 mm flat end; Type II: 400 g, 1.0 mm flat end)
  • Compressive strength specimens: cylindrical moulds 6 mm height × 4 mm diameter, cured and stored in water before testing; mechanical tester speed and loading rates are defined in Clause 7
  • Film‑thickness and arsenic (acid‑soluble fraction) test procedures are specified
• Biocompatibility guidance: refer to ISO 10993‑1 and ISO 7405
• Labelling and packaging: requirements for marking, instructions for use and retail packaging are included

Applications and practical value

• Ensures consistent performance and safety of temporary dental cements used by clinicians during:
  • provisional cementation of indirect restorations
  • temporary restorations and cavity bases
• Enables manufacturers to design, test and certify zinc‑oxide eugenol and non‑eugenol formulations to meet reproducible limits for setting behavior, strength, film thickness and contaminant control.
• Used by test laboratories, quality assurance teams, procurement and regulatory reviewers to verify compliance and to support product claims.

Who should use ISO 3107:2022

• Dental material manufacturers and R&D teams
• Clinical product managers and dental labs
• ISO/conformity assessment bodies and test laboratories
• Regulators and purchasers assessing temporary dental cements

Related standards

• ISO 10993‑1 (biocompatibility)
• ISO 7405 (dental materials - evaluation)
• ISO 1942, ISO 2590, ISO 3696, ISO 8601‑1 (referenced for terminology, arsenic testing, water quality and date/time formats)

Keywords: ISO 3107:2022, zinc oxide‑eugenol cements, non‑eugenol zinc oxide cements, temporary cementation, restorative dentistry, setting time, compressive strength, film thickness, dental standard.