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CEN
EN ISO 11609:2017

EN ISO 11609:2017

Current

Current

The latest, up-to-date edition.

Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)

Published date

21-06-2017

Publisher

Comite Europeen de Normalisation

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European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements relative to the physical and chemical
  properties of dentifrices
5 Test methods
6 Marking and labelling
7 Packaging
Annex A (informative) - Abrasivity test procedure - American
        Dental Association (ADA) method
Annex B (informative) - Determination of relative dentifrice
        abrasivity to enamel and dentine by a surface
        profile method
Annex C (informative) - Testing of total fluoride in
        dentifrices
Bibliography

ISO 11609:2017 specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices.ISO 11609:2017 applies to dentifrices, including toothpastes, destined to be used by the consumers on a daily basis with a toothbrush to promote oral hygiene.Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are not included in this document. These are covered in ISO 7405[1] and ISO 10993‑1[2].

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

ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 29621:2017 Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products
ISO 21149:2017 Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
ISO 22718:2015 Cosmetics Microbiology Detection of Staphylococcus aureus
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
BS 5136:1981 Specification for toothpastes
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
CFR 21(PTS300-499) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499
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 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
BIS IS 6356 : 2001 AMD 1 2014 TOOTHPASTE - SPECIFICATION
ISO 21148:2017 Cosmetics — Microbiology — General instructions for microbiological examination
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 21150:2015 Cosmetics Microbiology Detection of Escherichia coli
ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method

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