BS EN ISO 28399:2021

What is ISO 28399 about?  

ISO 28399 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. 

Note1: ISO 28399 is not applicable to tooth bleaching products. 

• ISO 28399 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 

Note2: ISO 28399 does not specify biological safety aspects of tooth bleaching products. 

Note3: maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body. 

Note4: ISO 28399 does not include specific qualitative and quantitative requirements for freedom from biological hazards. 

Who is ISO 28399 for? 

ISO 28399 on external tooth bleaching products is applicable to: 

• Dentist 
• Tooth bleaching products manufacturers and suppliers 
• Medical professionals 

Why should you use ISO 28399?  

External tooth bleaching products are used in dentistry for changing the colour of natural teeth towards a lighter or whiter shade. They are applied in the oral cavity directly on the outer surfaces of teeth. 

ISO 28399 provides requirements and test methods for external tooth bleaching products that are intended for use in the oral cavity, also ISO 28399 provides requirements for packaging, labelling, and manufacturer’s instructions for use.