Corrección de errores de la Comunicación de la Comisión en el marco de la aplicación de la Directiva 98/79/CE del Parlamento Europeo y del Consejo sobre productos sanitarios para diagnóstico in vitro (Publicación de títulos y referencias de normas armonizadas conforme a la legislación sobre armonización de la Unión) ( DO C 173 de 13.5.2016 )
Section | Corrección de errores |
Issuing Organization | Parlamento Europeo y Consejo de la Unión Europea |
8.7.2016 ES Diario Oficial de la Unión Europea C 249/206
En la página 139, norma EN ISO 15197:2015:
donde dice:
«CEN EN ISO 15197:2015 Sistemas de ensayo para diagnóstico in vitro. Requisitos para los sistemas de monitorización de glucosa en sangre para autodiagnóstico en la gestión de la diabetes mellitus. (ISO 15197:2013). Esta es la primera publicación EN ISO 15197:2013 Nota 2.1 30.6.2017 Respecto a las tiras reactivas de glucemia y las soluciones de control, la fecha de cese de la presunción de conformidad de la norma sustituida será el 30 de junio de 2017.»,
debe decir:
«CEN EN ISO 15197:2015 Sistemas de ensayo para diagnóstico in vitro. Requisitos para los sistemas de monitorización de glucosa en sangre para autodiagnóstico en la gestión de la diabetes mellitus. (ISO 15197:2013). 13.5.2016 EN ISO 15197:2003 Nota 2.1 31.7.2016 Respecto a las tiras reactivas de glucemia y las soluciones de control, la fecha de cese de la...
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