Comunicación de la Comisión en el marco de la aplicación de la Directiva 93/42/CEE del Consejo, de 14 de junio de 1993, relativa a los productos sanitarios y de la Directiva 98/79/CE del Parlamento Europeo y del Consejo, de 27 de octubre de 1998, sobre productos sanitarios para diagnóstico in vitro
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 del Consejo, de 14 de junio de 1993, relativa a los productos sanitarios (1) y de 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) (2002/C 182/05) (Texto pertinente a efectos del EEE) (PublicaciÛn de tÌtulos y referencias de normas armonizadas conforme a la Directiva) OEN (1) Referencia y tÌtulo de la norma Documento de referencia Referencia de la norma retirada y sustituida Fecha lÌmite para obtener presunciÛn de conformidad respecto a la norma sustituida Nota 1
CEN EN ISO 13485
Sistemas de calidad -- Productos sanitarios -- Requisitos particulares para la aplicaciÛn de la Norma EN ISO 9001 (revisiÛn de la Norma EN 46001:1996) (idÈntica a la Norma ISO 13485:1996) EN 46001 1.3.2004
CEN EN ISO 13488
Sistemas de calidad. Productos sanitarios -- Requisitos particulares para la aplicaciÛn de la Norma EN ISO 9002 (revisiÛn de la Norma EN 46002:1996) (idÈntica a la Norma ISO 13488:1996) EN 46002 1.3.2004
CEN EN ISO 14971
Productos sanitarios -- AplicaciÛn de riesgo de los productos sanitarios (ISO 14971:2000) EN 1441 1.4.2004 (1) OEN...
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