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BS EN ISO 16408:2015

BS EN ISO 16408:2015

$102.76

Dentistry. Oral care products. Oral rinses

Published By Publication Date Number of Pages
BSI 2015 20
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This International Standard 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.

This International Standard 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.

This International Standard is not applicable to oral rinses available by prescription only.

PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 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
11 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
12 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
13 10 Packaging
14 Annex A (normative) Determination of fluoride in oral rinses containing ionic fluoride compounds
17 Bibliography

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BS EN ISO 16408:2015
$102.76