This test method is not designed to prove the properties of polymer teeth and denture base materials.

This document specifies safety and user information requirements relating to the materials and design for manufactured products intended for sexual use.

This document covers only manufactured products that are intended to come in direct contact with genitals and/or the anus.

This document is not primarily intended for products classified as medical devices, cosmetics or assistive products for example lubricants, massage oil.

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.

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.