BS EN ISO 28399:2021 pdf download – Dentistry – External tooth bleaching products 4? Classification 4.1 General External tooth bleaching products can be classified for either: a) professional application; or b) consumer application. NOTE External tooth bleaching products can be used alone or in conjunction with auxiliary means of application. 4.2 Products for professional application These products are tooth bleaching products that are intended by the manufacturer to be applied only by dental professionals (in office tooth bleaching products). 4.3 Products for consumer application These products are tooth bleaching products that are intended by the manufacturer to be applied by the consumer (for professional home use or for non-professional home use). NOTE Such external bleaching products can be prescribed by a dental professional or directly available to consumers. 5 Requirements 5.1 Concentration of active ingredients for bleaching The concentration of active ingredients for bleaching (equivalent to hydrogen peroxide) delivered by the unexpired product according to manufacturer’s instructions for use shall be within the range of +10 % and −30 % of the original concentration stated by the manufacturer for the unopened product. Annex A or other equivalent method can be used for testing. 5.2 Surface microhardness The reduction in the Knoop hardness (KHN) or Vickers hardness (VHN) after bleaching shall not exceed 10 %, when tested in accordance with 6.3. 5.3 Surface erosion Surface erosion of the teeth tested shall be less than the level which is caused by the standard reference solution. The method described in Annex B or other equivalent methods can be used. 6 Measurements and test methods 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 µm 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...
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