ISO/TC 106/SC 7 - Oral care products

This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer. This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials. In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.

This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.

This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer's instructions for use. This document is not applicable to tooth bleaching products: — specified in ISO 11609; — intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; — auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This document does not specify biological safety aspects of tooth bleaching products. NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.

This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.

This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use. There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are: — a battery; — a motor; — a mechanical or magnetic drive system; — a moving brush head with tufted filaments. Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities. The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types, for example brush head plate retention can only be applied if the brush has a head portion that might get detached from the brush shaft. This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.

This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment. This document is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss is subsequently added. This document excludes specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405.

ISO 19448:2018 specifies test methods for the quantification of fluoride concentrations in dental products including dentifrices, gels, oral rinses, fluoride releasing varnishes, and other fluoride containing products. The methods are based on fluoride ion-selective electrode technology for the analysis of fluoride in aqueous samples derived from dental products.

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].

ISO 16409:2016 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer's instructions for use and labelling of the packaging. Excluded are interdental brushes with a plastic core. ISO 16409:2016 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments.

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.

ISO 28888:2013 specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues. The results of the screening method are intended for use in enamel and/or dentine erosion models.

ISO 22254:2005 specifies a test method for determining the resistance of the tufted portion of manual toothbrushes to deflection. This International Standard is applicable to toothbrushes having a conventional flat trim design and may not be applicable to toothbrushes with other designs. The results obtained with this International Standard may not correspond to consumer perceptions of the stiffness of toothbrush bristles.

This document specifies requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer's instructions for use. This document is not applicable to tooth bleaching products: — specified in ISO 11609; — intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; — auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This document does not specify biological safety aspects of tooth bleaching products. NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.

ISO 17730:2014 specifies requirements and their test methods for total digestible fluoride content in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling, including the instructions for use. This International Standard covers fluoride varnishes to be applied by dental health care workers.

This International Standard specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. This International Standard does not apply to manual interdental brushes and powered oral hygiene devices, as these instruments are covered by separate International Standards.

ISO 28399:2011 specifies requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products). It also specifies requirements for their packaging, labelling and instructions for use. The following tooth bleaching products are not covered by ISO 28399:2011: those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.

ISO 10873:2010 classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. ISO 10873:2010 is applicable to denture adhesives for use by the public and excludes the dental lining materials prescribed or applied by dental professionals. ISO 10873:2010 does not specify qualitative or quantitative requirements for freedom from biological hazards. For assessing possible biological hazards, see ISO 7405 and ISO 10993-1.

ISO 11609:2010 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 11609:2010 applies to dentifrices, including toothpastes, destined to be used by the public on a daily basis with a toothbrush to promote oral hygiene.

ISO 28158:2010 is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or dental floss and handles to which the floss is subsequently added. ISO 28158:2010 does not specify specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks.

ISO 16409:2006 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head. It also specifies the accompanying information, such as the manufacturer's instructions for use and labelling of the packaging. ISO 16409:2006 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings, nor is it applicable to interdental cleaners that do not include filaments.

ISO 20126:2005 specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. Specifically excluded are manual interdental brushes and powered oral hygiene devices as these instruments are covered by separate International Standards.

ISO 20127:2005 specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use. Specifically excluded are other types of powered oral hygiene devices (such as powered interdental brushes) and manual toothbrushes.

ISO 16408:2004 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as manufacturer's instructions for use, marking and/or labelling requirements. ISO 16408:2004 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 16408:2004 is not applicable to oral rinses available by prescription only.

Gives requirements and test methods for physical and chemical properties, and for marking and/or labelling of toothpastes for daily use with a toothbrush.

Specification of a test method and grading scheme for the stiffness of the tufted area of conventional manual tooth-brushes, together with the relevant information concerning definitions and those concerning testing machines. The original number of classifications of five categories has been reduced to three ones, i.e. soft, medium and hard. Eight definitions of important terms are given.