ISO 28399:2020

Dentistry — External tooth bleaching products

Publication date:   Mar 10, 2020

95.99 Withdrawal of Standard   Mar 22, 2021

General information

95.99 Withdrawal of Standard   Mar 22, 2021

ISO

ISO/TC 106/SC 7 Oral care products

International Standard

97.170   Body care equipment

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Scope

This document specifies 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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 28399:2011

NOW

WITHDRAWN
ISO 28399:2020
95.99 Withdrawal of Standard
Mar 22, 2021

REVISED BY

PUBLISHED
ISO 28399:2021