- | Are principally intended to be used with severe wounds that have substantially and extensively breached the dermis, and where the healing process can only be by secondary intent such as: |
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- | dressings for chronic extensive ulcerated wounds
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- | dressings for severe burns having breached the dermis and covering an extensive area | |
- | dressings for severe decubitis wounds | |
- | dressings incorporating means of augmenting tissue and providing a temporary skin substitute |
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- | Breached dermis: the wound exposes at least party the subcutaneous tissue. |
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- | Secondary intent: the wound heals by first being filled with granulation tissue, subsequently the epithelium grows back over the granulation tissue and the wound contracts. In contrast primary intent implies that the edges of the wound are close enough or pulled together. e.g. by suturing, to allow the wound to heal. |
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Products covered under this rule are extremely claim sensitive, e.g. a polymeric film dressing would be in Class II A if the intended use is to manage the micro-environment of the wound and in Class I if its intended use is limited to retaining an invasive cannula at the wound site. Consequently it is impossible to say a priori that a particular type of dressing is in a given class without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the wound healing process usually implies that the device is in Class II B. Most dressing that are intended for a use in Class II A or II B, also perform functions that are in Class I, e.g. that of a mechanical barrier. Such devices are nevertheless classed according to the intended use in the higher class. |
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 non invasivi premi qui; puoi anche tornare all'inizio o uscire. |
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