Is your device specifically intended for the cleaning, disinfection or sterilization of devices?
Disinfection is the act of disinfecting, using specialised
cleansing techniques that destroy or prevent growth of organisms capable of infection.
Sterilisation is the process of destroying all microorganisms and their pathogenic products. It can be accomplished by any of various methods, including heat, gas plasma, irradiation, or a bactericidal chemical compound such as ethylene oxide, peracetic acid, or aqueous glutaraldehyde.
Is your device intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses?
Is your device intended to clean devices by means of physical action only?
Is your device a disinfecting solution or washer-disinfector intended specifically to be used for disinfecting invasive devices, as the end point of processing?
Invasive device means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body
Disinfection is the act of disinfecting, using
specialised cleansing techniques that destroy or prevent growth of organisms capable of infection.
Is your device intended specifically to be used for disinfecting or sterilising medical devices?
Disinfection is the act of disinfecting, using specialised
cleansing techniques that destroy or prevent growth of organisms capable of infection.
Sterilisation is the process of destroying all microorganisms and their pathogenic products. It can be accomplished by any of various methods, including heat, gas plasma, irradiation, or a bactericidal chemical compound such as ethylene oxide, peracetic acid, or aqueous glutaraldehyde.