17 MAART 2009. - Koninklijk besluit tot wijziging van het koninklijk besluit van 18 maart 1999 betreffende de medische hulpmiddelen. - Erratum
Op pagina 24477 van het Belgisch Staatsblad van 27 maart 2009, editie 2, dient de tekst onder punt e) als volgt te worden gelezen :
e) onder punt 3.2 wordt punt c) als volgt vervangen :
c) de procedures om het ontwerp van de producten te controleren en te keuren, met inbegrip van de bijbehorende documentatie, in het bijzonder :
- een algemene beschrijving van het product, met inbegrip van de overwogen varianten en het voorziene gebruik ervan,
- ontwerpspecificaties, met inbegrip van de normen die zullen worden toegepast en de resultaten van de risicoanalyse, evenals de beschrijving van de oplossingen die worden aangenomen om te voldoen aan de geldende essentiële eisen die van toepassing zijn op de producten wanneer de in artikel 3, § 3, bedoelde normen niet volledig worden toegepast;
- de controle- en keuringstechnieken voor het ontwerp, de procédés en systematische maatregelen die bij het ontwerpen van de producten zullen worden toegepast;
- het bewijs dat, wanneer een hulpmiddel met één of meer andere hulpmiddelen verbonden moet worden om te kunnen functioneren overeenkomstig zijn bestemming, het hulpmiddel aan de essentiële eisen voldoet wanneer het wordt aangesloten op één of meer van deze hulpmiddelen die de kenmerken hebben die door de fabrikant zijn opgegeven;
- een...
Pour continuer la lecture
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