Le présent document spécifie les exigences générales et les méthodes d''essai concernant les produits d''assistance pour personnes en situation de handicap, qui constituent également des dispositifs médicaux, et satisfont aux Exigences essentielles désignées en termes généraux dans l''Annexe 1 de la Directive UE 93/42/CEE, modifiée par la Directive 2007/47/CE. Il n''est nullement destiné à fournir un moyen de prouver la conformité vis-à-vis d''exigences d''une autre Directive.
Le présent document spécifie des exigences, des recommandations et des méthodes d''essai concernant les aides techniques pour personnes handicapées.
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