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Devices used to treat wounds are as varied as there are wound conditions. Wounds can be surgically induced or may be the result of trauma or a chronic condition such as a diabetic ulcer. The extent of the wound to be treated can therefore range from a simple scratch, to a burn of varying degrees, to a deep wound that breaches multi-layers of tissue and even bone.
The following information addresses the evaluation of wound dressings in general.
Standards and Regulation
The investigator must take into account the biological category as indicated by ISO 10993-1, and whether the device is a solid material or liquid. Consideration also needs to be given to adhesives that may only contact areas around the wound.
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