ISO 16408:2015
Dentistry — Oral care 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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
5.1 pH value
5.2 Total fluoride concentration and maximum amount of fluoride
5.3 Unintended heavy metals
5.4 Compatibility with oral tissues
5.5 Microbial contamination
5.6 Stability against ageing
5.7 Container and/or dispensing system
5.8 Readily fermentable carbohydrates
6 Sampling
7 Test methods
7.1 General
7.2 Visual inspection
7.3 Determination of pH value
7.4 Determination of stability against ageing
7.4.1 Test
7.4.2 Compliance
7.5 Pass/fail criteria
8 Test report
9 Accompanying information
9.1 Manufacturer’s instructions for use
9.2 Information on the primary container, and on the secondary container, if it exists
10 Packaging
Annex A (normative) Determination of fluoride in oral rinses containing ionic fluoride compounds
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
5.1 pH value
5.2 Total fluoride concentration and maximum amount of fluoride
5.3 Unintended heavy metals
5.4 Compatibility with oral tissues
5.5 Microbial contamination
5.6 Stability against ageing
5.7 Container and/or dispensing system
5.8 Readily fermentable carbohydrates
6 Sampling
7 Test methods
7.1 General
7.2 Visual inspection
7.3 Determination of pH value
7.4 Determination of stability against ageing
7.4.1 Test
7.4.2 Compliance
7.5 Pass/fail criteria
8 Test report
9 Accompanying information
9.1 Manufacturer’s instructions for use
9.2 Information on the primary container, and on the secondary container, if it exists
10 Packaging
Annex A (normative) Determination of fluoride in oral rinses containing ionic fluoride compounds
Bibliography