ISO 11609:2017 PDF

Dentistry — Dentifrices — Requirements, test methods and marking

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Title (English):

ISO 11609:2017

Dentistry — Dentifrices — Requirements, test methods and marking

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 22
Publication date:: May 22, 2017
Edition:: ISO IS 11609 edition 3 version 1
ICS:: 97.170

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Description (English):

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].

Technical details

Technical committee: ISO/TC 106/SC 7 - Oral care products
SKU: ISO 11609:2017

Abstract

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).
pH
- 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

Related standards

Mentioned in the description and other ISO standards

Abstract

Overview

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).
pH
- 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

ISO 11609:2017 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Related standards

Abstract

Overview

Key topics and technical requirements

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