ISO 28399:2021

Overview

ISO 28399:2021 - "Dentistry - External tooth bleaching products" is an international standard that specifies requirements and test methods for external tooth-bleaching formulations intended for use in the oral cavity. It covers products for both professional (in‑office) and consumer (home) applications and includes requirements for packaging, labelling and manufacturer’s instructions. The standard excludes products covered by ISO 11609, mechanical stain‑removal or restorative approaches (veneers, crowns), and auxiliary materials/devices (trays, lights). Biological safety aspects are not specified in this document.

Key topics and technical requirements

• Classification
  • Products are classified as professional application (dental‑professional only) or consumer application (professional home use or non‑professional home use).
• Concentration of active ingredient
  • Measured concentration (equivalent to hydrogen peroxide) in the unexpired product must be within +10% / −30% of the manufacturer’s stated concentration.
• Surface microhardness
  • Reduction in enamel/dentine Knoop or Vickers hardness after bleaching shall not exceed 10% (test method specified).
• Surface erosion
  • Erosion caused by the product must be less than that caused by a defined standard reference solution (Annex B light microscopy method or equivalent).
• Specimen preparation and test conditions
  • Tooth specimen prep, application simulation and storage conditions (artificial saliva, 37 °C) are specified to simulate clinical use.
• Analytical test methods
  • Annex A: Modified thiosulfate titration for hydrogen peroxide content.
  • Annex B: Light microscopy method for enamel/dentine erosion measurement.
  • Annex C: Laboratory assessment of bleaching efficacy.
• Packaging and labelling
  • Mandatory information on outer package and instructions includes product name, manufacturer, lot number, expiry date, classification, active ingredient names and concentrations (and equivalent hydrogen peroxide), and instructions for use.

Practical applications - who uses ISO 28399:2021

• Manufacturers of tooth‑whitening gels, pastes and kits use the standard to design formulations, QC test plans and labelling to meet international expectations.
• Dental product test laboratories apply the specified specimen prep and measurement methods (microhardness, erosion, H2O2 titration, efficacy testing).
• Dental professionals and clinics rely on standardized performance claims when selecting in‑office bleaching materials.
• Regulators and conformity assessors reference the standard when evaluating product performance and labeling, while noting that maximum permitted bleaching concentrations remain subject to national regulation.

Related standards

• ISO 11609 (excluded scope for certain products)
• ISO 10993‑1, ISO 7405 (biological/toxicological assessment references)
• ISO 22727 (additional labelling guidance)
• ANSI/ADA Specification No. 41 (artificial saliva reference)
• ISO colorimetry and laboratory standards cited for testing consistency

For implementation, consult the full ISO 28399:2021 document and your national regulatory guidance for country‑specific limits on bleaching‑agent concentrations.