BS EN ISO 28399:2021 pdf download.Dentistry – External tooth bleaching products.. 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. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1042, Laboratory glass ware — One-mark volumetric flasks ISO 1942, Dentistry — Vocabulary ISO 3696, Water for analytical laboratory use — Specification and test methods ISO 6344-1. Coated abrasives — Grain size analysis — Part 1: Grain size distribution test ISO 860 1-1, Date and time — Representations for information interchange — Part 1: Basic rules ISO 860 1-2, Date and time — Representations for information interchange — Part 2: Extensions ISO/CIE 11664-1. Colorimetry — Part 1: CIE standard colorimetric observers ISO 11664-2. Colorimetry — Part 2: CIE standard iliuminants ANSI/ADA Specification No 41: Recommended Standard Practices for Biological Evaluation of Dental Materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISo Online browsing platform: available at https://www.iso.org/obp.BS EN ISO 28399 pdf download.
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