DIN EN ISO 16408:2015-12

Those who want fresh breath use an oral rinse or mouthwash. In order to achieve the desired positive effect without harmful side effects, the standard specifies physical and chemical requirements and test methods for oral rinsing solutions and mouthwashes. Marking and/or labeling requirements are also taken into account. Oral rinses and mouthwashes are classified in the standard according to their application by the user as follows: - Type 1: ready-for-use solutions; - Type 2: concentrated solutions for use after dilution with water; - Type 3: solutions for use after mixing. In Germany, ready-for-use solutions (Type 1) are designated as "Mundspüllösungen" ("mouth rinses")and concentrated solutions (Type 2) as "Mundwässer" ("mouth washes"). The standard describes requirements and test methods for the pH value, the total fluoride concentration and the maximum permissible fluoride quantity in a container, the maximum concentration of heavy metals, compatibility with the oral mucosa, microbial contamination, stability, containers and the dispenser system as well as the exclusion of easily fermentable carbohydrates (caries should not be caused). Information on the instructions for use and the required information on the primary container are also provided. The necessary warnings for alcoholic oral rinses and mouthwashes and their use by children are specified. This International Standard has been prepared by ISO/TC 106/SC 7/WG 3 "Oral care products" (secretariat: DIN) together with CEN/TC 55 "Dentistry" (secretariat: DIN). The committee responsible for this standard is NA 014-00-19 AA "Mundpflegeprodukte" ("Oral hygiene products") at NADENT at DIN.