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<p>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.</p>
<p>This document is not applicable to tooth bleaching products:</p>
<p>— specified in ISO 11609;</p>
<p>— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;</p>
<p>— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.</p>
<p>This document does not specify biological safety aspects of tooth bleaching products.</p>
<p>NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.</p>
Reģistrācijas numurs (WIID)
81568
Darbības sfēra
<p>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.</p>
<p>This document is not applicable to tooth bleaching products:</p>
<p>— specified in ISO 11609;</p>
<p>— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;</p>
<p>— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.</p>
<p>This document does not specify biological safety aspects of tooth bleaching products.</p>
<p>NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.</p>
