SIST EN ISO 28399:2021 PDF

EN ISO 28399:2021 - Overview

EN ISO 28399:2021 specifies requirements and test methods for external tooth bleaching products used in the oral cavity, for both professional (in‑office) and consumer (home) applications. It covers product formulation performance, stability of the active bleaching agent, effects on tooth surfaces, and the packaging, labelling and manufacturer’s instructions for use required to support safe and effective use. The standard is a CEN-adopted version of ISO 28399:2021 and supersedes EN ISO 28399:2020.

Key topics and technical requirements

• Scope & classification
  • Applies to external chemical bleaching products for natural teeth (professional and consumer use).
  • Excludes products covered by ISO 11609, mechanical stain-removal methods (e.g., abrasives, veneers), and auxiliary materials/devices (trays, lights).
  • Does not specify biological safety (see ISO 10993-1 and ISO 7405 for biocompatibility).
• Active ingredient concentration
  • Measured as hydrogen‑peroxide equivalent; delivered concentration for unexpired product must be within +10% / −30% of the manufacturer’s stated concentration when used per instructions. (Annex A describes measurement.)
• Tooth surface effects
  • Surface microhardness: reduction in Knoop or Vickers hardness after bleaching shall not exceed 10% (test method in clause 6.3).
  • Surface erosion: erosion must be less than that caused by a defined standard reference solution (light microscopy method in Annex B).
• Performance testing
  • Annex C provides a laboratory method for assessing bleaching efficacy.
• Packaging, labelling and instructions
  • Requirements for safe packaging, clear marking, dosage, application instructions and shelf‑life information are specified to support proper use by professionals and consumers.

Practical applications - who uses this standard

• Manufacturers and product developers of tooth whitening gels, strips and kits - to design, test and document product performance and stability.
• Quality managers and regulatory teams - to demonstrate compliance for market access across CEN/ISO markets and to prepare technical files.
• Test laboratories - to perform standardized assays for hydrogen peroxide concentration, enamel/dentine erosion and microhardness.
• Dental professionals and procurement - to evaluate product claims and ensure selection of safe, standardized bleaching products.
• Regulators and notified bodies - to reference objective test methods and acceptance criteria during review.

Related standards

• ISO 11609 (excluded product types)
• ISO 10993-1, ISO 7405 (biocompatibility guidance)
• ISO/CIE 11664 series (colorimetry)
• ISO 3696, ISO 1042 and ANSI/ADA Specification No 41 (referenced test and laboratory standards)

EN ISO 28399:2021 is essential for ensuring reliable, quality-controlled tooth bleaching products, balancing efficacy with preservation of enamel integrity and informative packaging/labeling for safe dental care.