prBAS EN ISO 16408:2026

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.