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DIN EN 14136:2004-08

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004

Fecha edición: 2004-08-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: This European Standard applies to external quality assessment schemes (EQAS) that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to scheme design and organization, identification of procedures (IVD MDs) used by the participant as well as to classification and evaluation of data.

Keywords: Biochemicals|CE marking|Chemical analysis and testing|Control method|Definitions|Diagnosis|Evaluations|Human medicine|In vitro|Inter-laboratory tests|In-vitro diagnostic|Laboratories|Laboratory medicine|Laboratory testing|Laboratory tests|Measuring techniques|Medical sciences|Methods of analysis|Organization|Programmes|Quality assurance|Quality assurance systems|Quality control|Specification (approval)|Structure|Test results|Testing
ICS: 11.100.10 - Sistemas de ensayo para diagnóstico in vitro
CTN:

Equivalencia Internacional

Idéntica EN 14136:2004

Reemplazo Normas

Reemplaza a DIN EN 14136:2001-05

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