BS EN ISO 16408-2015 PDF

Full title and description

BS EN ISO 16408:2015 — Dentistry. Oral care products. Oral rinses. This is the British adoption of the second edition of ISO 16408 (2015), which specifies physical and chemical requirements, test methods and information/label‑ling requirements for non‑prescription oral rinses (mouthwashes / oral rinses).

Abstract

ISO 16408:2015 sets out requirements and test methods for oral rinses (ready‑for‑use, concentrates for dilution, and solutions for mixing). It covers parameters such as pH, fluoride content and limits, unintended heavy metals, microbial contamination, stability, container and dispenser compatibility, exclusion of easily fermentable carbohydrates, and required instructions/warnings (including special warnings for alcoholic products and children). It excludes other delivery systems (e.g. sprays, foams, powders) and prescription‑only products.

General information

• Status: Withdrawn (replaced by a later edition — ISO 16408:2025 available).
• Publication date: 2015‑08 (published 2015; British adoption commonly dated in late 2015).
• Publisher: International Organization for Standardization (ISO); published as a CEN/EN/BS adoption (BSI adopted EN ISO text as BS EN ISO).
• ICS / categories: 97.170 (oral care / personal care products).
• Edition / version: Edition 2 (2015).
• Number of pages: 9 (ISO bibliographic record shows 9 pages for the ISO edition; national publication page counts may vary).

Scope

This standard applies to oral rinses intended for oral hygiene and breath‑freshening that are supplied as ready‑for‑use solutions, concentrates for dilution, or solutions for mixing. It specifies limits and test methods for chemical and physical properties (pH, fluoride levels and maximum fluoride per container, unintended heavy metals), microbiological quality, stability (including real‑time ageing conditions), container/dispenser compatibility, labelling and instructions for safe use. It is not intended for other delivery systems (mouthsprays, foams, powders) nor for prescription‑only oral rinses.

Key topics and requirements

• Classification of oral rinses by type: ready‑to‑use, concentrates, and mixtures for use.
• Physical and chemical requirements: pH limits and methods, total fluoride concentration and maximum fluoride per container.
• Limits for unintended heavy metals and related test methods.
• Microbial contamination limits and suitability / compatibility with oral mucosa.
• Stability and ageing tests (real‑time and accelerated conditions) and storage condition specifications.
• Container, dispenser and packaging requirements to ensure product integrity and dosing.
• Instructions for use, marking/label‑ling requirements and mandatory warnings (including alcohol‑containing products and children).
• Exclusion of easily fermentable carbohydrates to reduce caries risk.

Typical use and users

Manufacturers and formulators of oral‑care / mouthwash products, quality and regulatory teams, testing laboratories performing physicochemical and microbiological tests, standards and compliance officers, procurement and product safety personnel in dental and healthcare industries, and national standards bodies referencing or adopting the ISO/CEN/BS text.

Related standards

References and close‑by standards include ISO/TC 106 (dentistry) publications and other oral‑care test methods; the ISO text itself references standards such as ISO 28888 for related testing and cites earlier and later revisions (ISO 16408:2004 was the previous edition; ISO 16408:2025 is the published revision). National adoptions appear as EN ISO / BS EN ISO versions.

Keywords

oral rinse; mouthwash; oral care products; dentistry; pH testing; fluoride concentration; heavy metals; microbial limits; stability testing; labelling; dispenser compatibility; ISO 16408; BS EN ISO.

FAQ

Q: What is this standard?

A: ISO 16408:2015 (published as BS EN ISO 16408:2015 in the UK) is an international standard that specifies requirements and test methods for oral rinses (mouthwashes), covering chemical, physical and microbiological criteria plus labelling and packaging considerations.

Q: What does it cover?

A: It covers classification of oral rinses, limits and test methods for pH, total fluoride and maximum fluoride per container, unintended heavy metals, microbiological contamination, stability/ageing, container and dispenser compatibility, instructions for use and warnings (e.g. for alcohol content and children), and exclusion of fermentable carbohydrates. It excludes other delivery systems and prescription‑only products.

Q: Who typically uses it?

A: Product manufacturers, formulators, testing laboratories, regulators, standards/quality teams in oral‑care and dental sectors, and organizations procuring or assessing mouthwash products.

Q: Is it current or superseded?

A: The 2015 edition is recorded as withdrawn on ISO’s bibliographic record and has been revised — a newer edition ISO 16408:2025 is available. Users should refer to the 2025 edition for current requirements.

Q: Is it part of a series?

A: It belongs to the ISO/TC 106 dentistry family and to the subgroup of standards covering oral care products; related documents include earlier ISO 16408:2004 and other ISO test methods referenced within the standard (for example ISO 28888 where applicable).

Q: What are the key keywords?

A: Oral rinse, mouthwash, oral care, dentistry, pH, fluoride, heavy metals, microbiological quality, stability testing, labelling, dispenser, ISO 16408.