EN ISO 16408:2025

Dentistry - Oral care products - Oral rinses (ISO 16408:2025)

Publication date:   Sep 18, 2025

General information

60.60   Standard published   Jul 2, 2025

CEN

CEN/TC 55 Dentistry

European Norm

97.170   Body care equipment

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Scope

This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 16408:2015

NOW

PUBLISHED
EN ISO 16408:2025
60.60 Standard published
Jul 2, 2025

REVISED BY

IN_DEVELOPMENT
prEN ISO 16408 rev