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ISO 28399:2020

Dentistry -- External tooth bleaching products

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Kehtiv alates 10.03.2020
Tegevusala (ICS grupid)
97.170 Kehahooldevahendid
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
10.03.2020
Põhitekst
14.01.2011
Põhitekst
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.
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