As a result of European unification, new regulations valid within the territory of the European Union (EU) have been negotiated and published.
As in other medical fields, the Medical Device Directive (MDD) is the most important new regulation and also effects endoscopy.
In a transition period until June 1998, the MDD will be transposed into national law by the member states of the EU.
Compliance with the MDD and other European regulations is indicated by the CE mark affixed to the product.
Mots-clés Pascal : Endoscopie, Réglementation, Norme sécurité, Equipement, Commission, Agrément certificat, Homme, Communauté européenne, Génie biomédical
Mots-clés Pascal anglais : Endoscopy, Regulation, Safety standard, Equipment, Commission, Agrements, Human, European community, Biomedical engineering
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0536465
Code Inist : 002B30A09. Création : 01/03/1996.