RULE 17 | EXAMPLES | |
All devices manufactured utilizing animal tissues or derivatives1 rendered non-viable are Class III except where such devices are intended to come into contact with intact skin2 only. |
- Biological heart valves, porcine xenograft dressings, catgut sutures, implants and dressings made from collagen. |
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Pratical classification issues - Devices made of non-viable animal tissue that come into contact with intact skin only (e.g. leather components of orthopedic appliances) are in Class I in accordance to rule 1. |
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Note 1: Derivatives are products that are processed from animal tissues and exclude substances such as milk, silk, beeswax, hair, lanolin. | ||
Note 2: Intact skin includes the skin around an established stoma unless the skin is breached. |
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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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