ISO 28399:2021

International Standard   Current Edition
· Approved on 22 March 2021 ·

Dentistry — External tooth bleaching products

Body care equipment
Including hair-driers, razors, shavers, toothbrushes, massage appliances, radiation skin treatment appliances, etc.

ISO 28399:2021 Files

null Pages
Current Edition

ISO 28399:2021 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.

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