ISO 28399:2021 PDF

Scope: This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use. This document is not applicable to tooth bleaching products: — specified in ISO 11609; — intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; — auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This document does not specify biological safety aspects of tooth bleaching products. NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.

ISO 28399:2021 Referenced Document

ISO 1042 Laboratory glassware - One-mark volumetric flasks
ISO 11664-2 Colorimetry — Part 2: CIE standard illuminants
ISO 1942 Dentistry — Vocabulary — Amendment 1
ISO 3696 Water for analytical laboratory use; Specification and test methods
ISO 6344-1 Coated abrasives — Grain size analysis — Part 1 : Grain size distribution test
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical corrections*， 2022-10-25 Update
ISO 8601-2 Date and time — Representations for information interchange — Part 2: Extensions — Amendment 1
ISO/CIE 11664-1 Colorimetry — Part 1: CIE standard colorimetric observers