ISO 16408:2004 PDF Download

The physical and chemical specifications for oral rinses used in the field of dentistry are laid forth in ISO 16408:2004. To guarantee the caliber and efficacy of these products, it offers guidelines and test procedures. The standard also addresses further details that must be included with the device, such as usage instructions from the manufacturer and standards for labeling.

However, it's crucial to remember that additional delivery methods, including mouthwash, foams, and powders, are not covered by ISO 16408:2004. Additionally, it doesn't discuss regulatory issues, such as prescription techniques. Additionally, the norm does not apply to oral rinses that can only be obtained with a prescription.