Comunicación de la Comisión en el marco de la aplicación de la Directiva 93/42/CEE de 14 de junio de 1993, relativa a los productos sanitarios, la Directiva 98/79/CE del Parlamento Europeo y del Consejo, de 27 de octubre de 1998, sobre productos sanitarios para diagnóstico in vitro y la Directiva 90/385/CEE del Consejo, de 20 de junio de 1990,...
Section | Directive |
Issuing Organization | Comisión de las Comunidades Europeas |
ComunicaciÛn de la ComisiÛn en el marco de la aplicaciÛn de la Directiva 93/42/CEE de 14 de junio de 1993, relativa a los productos sanitarios (1), la Directiva 98/79/CE del Parlamento Europeo y del Consejo, de 27 de octubre de 1998, sobre productos sanitarios para diagnÛstico in vitro (2) y la Directiva 90/385/CEE del Consejo, de 20 de junio de 1990, relativa a la aproximaciÛn de las legislaciones de los Estados miembros sobre productos sanitarios implantables activos (3) (2003/C 32/04) (Texto pertinente a efectos del EEE) (PublicaciÛn de los tÌtulos y de las referencias de las normas armonizadas europeas de acuerdo con lo previsto en la Directiva) OEN (1) Referencia TÌtulo de la norma armonizada CEN EN ISO 13485:2000 Sistemas de calidad -- Productos sanitarios -- Requisitos particulares para la aplicaciÛn de la Norma EN ISO 9001:1994 (revisiÛn de la Norma EN 46001:1996) CEN EN ISO 13488:2000 Sistemas de calidad -- Productos sanitarios -- Requisitos particulares para la aplicaciÛn de la Norma EN ISO 9002:1994 (revisiÛn de la Norma EN ISO 46002:1996) (1) Organismos europeos de normalizaciÛn (OEN):
-- CEN: rue de Stassart/Stassartstraat 36, B-1050 Bruxelles/Brussel; tel.: (32-2) 550 08 11, fax: (32-2) 550 08 19 (http://www.cenorm.be);
-- Cenelec: rue de Stassart/Stassartstraat 35, B-1050 Bruxelles/Brussel; tel.: (32-2) 519 68 71...
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