ISO 16408:2025

ISO 16408:2025

June 2025
International standard Current

Dentistry - Oral care products - Oral rinses

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.

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Main informations

Collections

International ISO standards

Publication date

June 2025

Number of pages

8 p.

Reference

ISO 16408:2025

ICS Codes

97.170   Body care equipment

Print number

1
Sumary
Dentistry - Oral care products - Oral rinses

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.

Replaced standards (1)
ISO 16408:2015
August 2015
International standard Cancelled
Dentistry - Oral hygiene products - Oral rinses

ISO 16408:2015 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as the manufacturer's instructions for use, marking, and/or labelling requirements. ISO 16408:2015 is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription. ISO 16408:2015 is not applicable to oral rinses available by prescription only.

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