BS EN ISO 28399:2020 pdf free.Dentistry – External tooth bleaching products.
BS EN ISO 28399 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.6.1 Preparation of tooth specimens Prepare enamel and dentine specimens taken from a consistent location on extracted human or bovine teeth, that have been stored in a neutralized solution that disinfects but does not alter the physical
properties. Grind the specimen surface under a constant flow of water in accordance with ISO 3696 starting at P400 and sequentially to a minimum of P1200 silicon carbide paper in accordance with ISO 6344-1. Then polish the surface using a slurry or paste of 0,3 um mean particle size aluminium oxide. Ensure a minimum of 1 mm thickness of enamel or dentine tissue for the test specimen. Prevent dehydration of test specimens during the preparation procedure.6.2 Preparation and application of tooth bleaching product The dispensing, processing and application of the tooth bleaching product used in tests (see Annex C) shall follow the manufacturer’s instructions for use. The method of bleach application shall simulate the clinical procedure in quantity, frequency and duration of the application. Between bleaching intervals, and for 24 h after the last bleach application prior to testing, specimens shall be stored at 37。C in an artificial saliva solution similar to that described in the ANSI/ADA Specification No.41[41. 6.3 Surface microhardness Evaluate enamel surface microhardness before and after bleaching treatment. Determine KHN or VHN surface microhardness by applying a load of 0,49 N (equivalent to a 50 g load) for 15 s. Evaluate a minimum of 10 specimens for each group, with three indentations for each specimen. Prevent dehydration of test specimens during the specimen preparation procedure. BS EN ISO 28399 pdf download.