ISO 28888:2013 PDF

Overview

ISO 28888:2013 is an international standard developed by the International Organization for Standardization (ISO) that specifies a screening method to evaluate the erosion potential of non-fluoridated oral rinses on dental hard tissues such as enamel and dentine. The purpose of this standard is to provide a reliable and reproducible initial assessment of how oral rinses may chemically wear down dental tissues, which is essential for product safety and efficacy validation in dentistry.

This standard is widely recognized in dental medicine and oral hygiene product development, enabling manufacturers to screen products efficiently for erosion risk before advancing to more complex clinical or laboratory tests.

Key Topics

• Screening Method for Dental Erosion The standard defines a laboratory procedure that measures the change in pH when a non-fluoridated oral rinse is introduced to a calcium phosphate solution simulating dental hard tissue conditions. A key indicator is the maximum allowable decrease in pH, set at 1.0; exceeding this denotes potential erosion risk.

• Materials and Reagents ISO 28888:2013 specifies the use of various chemical reagents including calcium chloride, potassium phosphate, citric acid, potassium hydroxide, and sodium azide to prepare solutions that mimic the oral environment. The accuracy of reagent preparation and sample handling is critical to ensure test validity.

• Apparatus and Measurement The test requires precise equipment such as an analytical balance, pH meter (with a sensitivity of ±0.05 pH units), magnetic stirrer, and temperature control to perform reproducible and standardized measurements.

• Test Procedure

  • Prepare phosphate-calcium buffer solution at controlled pH
  • Measure baseline pH
  • Introduce 0.25 ml of the oral rinse sample
  • Monitor pH change until it stabilizes
  • Repeat measurements to calculate average pH variation and standard deviation If the average pH drop across samples exceeds 1.0, the rinse fails the screening and must undergo further detailed erosion testing.

• Reporting Results The standard outlines detailed reporting requirements including product identification, sample numbers, pass/fail indications, and test conditions, ensuring transparency and traceability.

Applications

• Oral Hygiene Product Development Manufacturers use ISO 28888:2013 to conduct early-stage safety screening of new non-fluoridated mouthwash formulations, minimizing risks of enamel and dentine erosion for consumers.

• Regulatory Compliance Regulatory bodies rely on standardized screening methods to evaluate dental product claims related to safety and oral tissue compatibility.

• Research and Clinical Studies The method offers a foundation for laboratory models that simulate dental erosion processes, supporting scientific investigations into material-tissue interactions and oral health.

• Quality Control Routine testing of production batches can ensure consistency and conformity with erosion potential safety thresholds.

Related Standards

• ISO 16408 – Dental products - Oral hygiene products - Mouth rinses: Specifies broader testing conditions for mouth rinse erosion potential under conditions simulating clinical use.

• ISO 11609 – Dentistry - Dentifrices: Specifies requirements and test methods related to toothpastes.

• ISO 3696 – Water for analytical laboratory use: Provides specifications for water purity essential for reagent preparation in dental material tests.

• ISO 28399 – Dental whitening products: Covers safety and testing of external-use whitening compounds that may affect dental tissues.

Keywords

Screening method, oral rinses, dental erosion, enamel erosion, dentine erosion, ISO 28888, non-fluoridated mouthwash, dental hard tissues, pH measurement, oral hygiene product safety, erosion potential testing, dental product standards, calcium phosphate buffer, dental materials testing, oral care product development, regulatory compliance dentistry.