- | Body liquid collection devices intended to be used in such a way that a return flow is unlikely (e.g. to collect body wastes such as urine collection bottles, ostomy pouches, incontinence pads or collectors, used with wound drainage devices). They may be connected to the patient by means of catheters and tubing |
- | Devices used to immobilize body parts and/or to apply force or compression on them (e.g. non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical collars, gravity traction devices, compression hosiery) |
- | Devices intended in general for external patient support (e.g. hospital beds, patient hoists, walking aids, wheelchairs, stretchers, dental patient chairs) |
- | Corrective glasses, frames, stethoscopes for diagnosis, eye occlusion plasters, incision drapes, conductive gels, non-invasive electrodes (electrodes for EEG or ECG), image intensifying screens |
- | Permanent magnets for removal of ocular debris |
Some non-invasive devices are indirectly in contact with the body and can influence internal physiological processes by storing channeling or treating blood, other body liquids or liquids which are returned or infused into the body or by generating energy that is delivered to the body. These must be excluded from the application of this rule and be handled by another rule because of the hazards inherent in such indirect influence on the body. |
Se si tratta di un dispositivo attivo, prendi nota della presente classificazione ma vai a verificare se da una delle regole aggiuntive previste per i dispositivi medici attivi scaturisce la classificazione in una classe più elevata. |
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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 tra i dispositivi invasivi premi qui; puoi anche tornare all'inizio o uscire. |
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