ISO 11609:2017

Name: ISO 11609:2017 — Dentistry — Dentifrices — Requirements, test methods and marking
SKU: ISO 11609:2017
Price: 25 EUR
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Dentistry — Dentifrices — Requirements, test methods and marking

Название (английский):

ISO 11609:2017

Dentistry — Dentifrices — Requirements, test methods and marking

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 22
Дата публикации:: 22 мая 2017 г.
Издание:: ISO IS 11609 edition 3 version 1
ICS:: 97.170

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Описание (английский):

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].

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 11609:2017 - Dentistry - Dentifrices - Requirements, test methods and marking defines international requirements and test methods for consumer dentifrices (including toothpastes). The standard covers the physical and chemical properties, stability, abrasivity, microbiology, and the marking, labelling and packaging required for daily-use oral hygiene products. It does not set specific toxicological or biological safety limits (see related standards below).

Keywords: ISO 11609:2017, dentifrices, toothpaste standards, dentifrice test methods, dentifrice labelling

Key topics and technical requirements

Scope and definitions

Applies to consumer dentifrices and toothpastes intended for daily use with a toothbrush.
Defines terms such as “dentifrice”, “toothpaste”, “single‑unit container” and “primary container”.

Fluoride

Total fluoride must not exceed 0.15% (mass fraction) when tested per Annex C or equivalent validated methods.
A single‑unit container shall not contain more than 300 mg total fluoride, except for professionally dispensed products or community programmes.

Heavy metals

Total heavy metals shall not exceed 20 mg/kg (tested by validated analytical methods).

Dentifrice pH must be below 10.5. pH test: suspend 1 part product in 3 parts ISO 3696 grade water and measure within 10 minutes.

Abrasivity

Abrasivity limits relative to a primary reference: dentine ≤ 2.5× and enamel ≤ 4× (methods in Annex A & B, including ADA method).

Stability and shelf‑life

Products must show no deterioration after accelerated ageing (40 °C ±2 °C, 75% ±5% RH for 3 months) or after 30 months at room temperature. If unstable, an expiry date is required.

Microbiology and ingredients

Microbiological testing is required using validated methods; dentifrices must not contain readily fermentable carbohydrates.

Marking and labelling

Primary containers (except very small units) must show: the word “dentifrice”, trade name, manufacturer contact, production date/tracking code, INCI ingredient list, fluoride type and concentration, net volume/mass, expiry date (if <30 months), and a safety notice for children under 6 if fluoride ≥ 1 000 µg/g.

Packaging

Packaging must prevent contamination under normal handling and after ageing.

Practical applications - who uses ISO 11609:2017

Dentifrice and toothpaste manufacturers for product formulation, QC and regulatory compliance.

R&D and laboratory teams conducting abrasivity, fluoride and stability testing.

Regulatory affairs and quality assurance professionals preparing labelling and safety documentation.

Procurement and certification bodies assessing product conformity to international dentifrice standards.

Related standards

ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

ISO 10993‑1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 3696 - Water for analytical laboratory use

International Nomenclature of Cosmetic Ingredients (INCI) - ingredient labelling

ISO 11609:2017 is the reference standard for dentifrice safety, performance testing and labelling that supports consistent product quality and international market access.

ISO 11609:2017

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications - who uses ISO 11609:2017

Related standards

Технические детали

BS EN ISO 3696:1995

Water for analytical laboratory use. Specification and test methods.

ISO 7405:2018

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials