Skip to content
Please enter a keyword to search

  • EN ISO 16408:2015

    Current The latest, up-to-date edition.

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

    Available format(s): 

    Language(s): 

    Published date:  09-09-2015

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 55
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 28888:2013 Dentistry Screening method for erosion potential of oral rinses on dental hard tissues
    ISO 11930:2012 Cosmetics Microbiology Evaluation of the antimicrobial protection of a cosmetic product
    ISO 29621:2017 Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products
    ISO 11609:2017 Dentistry — Dentifrices — Requirements, test methods and marking
    ISO 22718:2015 Cosmetics Microbiology Detection of Staphylococcus aureus
    ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
    ISO 22717:2015 Cosmetics Microbiology Detection of Pseudomonas aeruginosa
    AS 2827-1985 Toothpastes
    ISO 16212:2017 Cosmetics — Microbiology — Enumeration of yeast and mould
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 1942:2009 Dentistry Vocabulary
    ISO/TR 17276:2014 Cosmetics Analytical approach for screening and quantification methods for heavy metals in cosmetics
    ISO 18416:2015 Cosmetics Microbiology Detection of Candida albicans
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 21148:2017 Cosmetics — Microbiology — General instructions for microbiological examination
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 12787:2011 Cosmetics Analytical methods Validation criteria for analytical results using chromatographic techniques
    ISO 21150:2015 Cosmetics Microbiology Detection of Escherichia coli
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective