RULE 15 | EXAMPLES | |
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate hydrating contact lenses are in Class IIb. |
- Contact lens solutions, comfort solutions. |
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All devices intended specifically to be used for disinfecting medical devices are in Class IIa. |
- Disinfectants specifically intended for instance for endoscopes or haemodialysis equipment, sterilizers specifically intended to sterilize medical devices in a medical environment and washer disinfectors. |
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This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action1.
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Pratical issues of classification Note 1: This rule does not apply to mechanical means of cleaning of devices, such as brushes and ultrasound. Such products will only fall under this directive if they are specifically intended for use with medical devices. |
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Esempi e precisazioni dalla MEDDEV 2.4/1
Qui termina il percorso per la classificazione del dispositivo di tuo interesse. Se vuoi ripercorrere il cammino fatto premi qui; puoi anche tornare all'inizio o uscire. |
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