Name: EN ISO 16408:2015
Brand: CEN

Dentistry - Oral care products - Oral rinses (ISO 16408:2015)

Published date

09-09-2015

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Sampling
7 Test methods
8 Test report
9 Accompanying information
10 Packaging
Annex A (normative) - Determination of fluoride in oral
rinses containing ionic fluoride compounds
Bibliography

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.

Committee	CEN/TC 55
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
UNI EN ISO 16408:2015	Identical
NBN EN ISO 16408 : 2015	Identical
BS EN ISO 16408:2015	Identical
I.S. EN ISO 16408:2015	Identical
DIN EN ISO 16408:2015-12	Identical
SN EN ISO 16408:2015	Identical
UNI EN ISO 16408 : 2004	Identical
ISO 16408:2015	Identical
UNE-EN ISO 16408:2016	Identical
NEN EN ISO 16408 : 2015	Identical
SS-EN ISO 16408:2015	Identical
NF EN ISO 16408 : 2015	Identical
NS EN ISO 16408 : 2004	Identical
PN EN ISO 16408 : 2016	Identical

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AS 2827-1985	Toothpastes
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ISO 1942:2009	Dentistry Vocabulary
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ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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