EN ISO 28888:2013 PDF

Overview

EN ISO 28888:2013 - “Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues” (ISO 28888:2013) is a CEN-endorsed laboratory screening standard for assessing the potential of non‑fluoridated oral rinses to cause dental erosion. The method provides a rapid, reproducible in vitro pH‑based screening procedure whose results feed into enamel and/or dentine erosion models. Products that exceed the screening threshold are referred to more complex erosion testing.

Key Topics and Requirements

• Scope: Screening test for erosion potential of non‑fluoridated oral rinses on enamel and dentine. Results are intended for use in erosion models.
• Pass/fail criterion: Maximum allowable mean pH decrease = 1.0 pH unit. A larger decrease means the rinse fails the screening and requires further testing (e.g., ISO 16408).
• Sampling: Two representative samples from each of three production batches (total six samples). Each sample is tested in four replicate runs.
• Test solution & volumes:
  • Prepare a calcium‑phosphate diluted screening solution from two 1 mol/L stock solutions (CaCl2·2H2O and KH2PO4).
  • Use 25 ml of the screening solution in a 50 ml reaction vessel and add 0.25 ml of test oral rinse or reference buffer.
• Operating conditions: Ambient temperature 18–27 °C, stirring above ~100 r/min, pH measured with a calibrated electrode (sensitivity ±0.05 pH units).
• Reference buffers and reagents: Three citrate buffer references (approximate pH 3.60, 3.68, 3.77) and specified reagent list (citric acid, trisodium citrate dihydrate, CaCl2, KH2PO4, sodium azide preservative, etc.).
• Data reporting: Record starting pH, test material pH, final pH, pH change per run; report mean and standard deviation for six samples.

Applications and Who Uses It

• Oral care manufacturers use ISO 28888 for early-stage formulation screening to avoid erosive oral rinse products.
• R&D and quality control laboratories apply the method for batch verification and stability testing of non‑fluoridated rinses.
• Regulatory bodies and conformity assessors reference the screening outcome when evaluating product safety claims related to dental hard tissue compatibility.
• Dental researchers use the standardized screening data as inputs for enamel/dentine erosion models and follow‑up in vitro or clinical studies.

Practical benefits include a standardized, reproducible pH‑based protocol that helps quickly identify potentially erosive formulations before committing to resource‑intensive, clinically relevant testing.

Related Standards

• ISO 16408 - referred to for more complex erosion testing when a product fails this screening.
• ISO 3696, ISO 78‑2, ISO 1942 - normative references for water quality, chemical analysis layout, and dental vocabulary used in this method.

Keywords: ISO 28888, EN ISO 28888, dental erosion screening, oral rinses, erosion potential, enamel erosion, dentine erosion, pH decrease, oral care testing, non‑fluoridated mouthwash.