11.100.10 In vitro diagnostic test systems
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Price exclude VAT will be charged for customers of European Union – VAT payers (with valid EU VAT number) and for customers outside of European Union.
in stock
Released: 2002-10-29
General requirements for in vitro diagnostic medical devices for self-testing.
Requisitos generales de los productos sanitarios para diagnóstico in vitro para autodiagnóstico.
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Released: 2002-07-29
Performance evaluation of in vitro diagnostic medical devices.
Evaluación del funcionamiento de los productos sanitarios para diagnóstico in vitro.
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Released: 2003-12-12
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
Procedimientos de muestreo utilizados para los ensayos de aceptación de productos sanitarios para diagnóstico in vitro. Aspectos estadísticos.
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Released: 2011-11-16
Laboratory glass and plastics ware. Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011)
Material de laboratorio de vidrio o de plástico. Tubos y soportes para la medición de la velocidad de sedimentación de hematíes por el método Westergren. (ISO 13079:2011)
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Released: 2009-11-25
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
Productos sanitarios para diagnóstico in vitro. Medición de magnitudes en muestras de origen biológico. Requisitos para el contenido y la presentación de los procedimientos de medida de referencia. (ISO 15193:2009)
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Released: 2009-11-25
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
Productos sanitarios de diagnóstico in vitro. Medida de cantidades en muestras de origen biológico. Requisitos para los materiales de referencia certificados y el contenido de la documentación justificativa. (ISO 15194:2007)
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Released: 2015-09-23
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
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).
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Released: 2013-07-24
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
Ensayos de laboratorio clínico y sistemas de ensayo de diagnóstico in vitro. Método de referencia para ensayos in vitro de la actividad de agentes antimicrobianos contra hongos levaduriformes que causan enfermedades infecciosas. (ISO 16256:2012).
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Released: 2012-02-22
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 1: Términos, definiciones y requisitos generales. (ISO 18113-1:2009)
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Released: 2012-02-22
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 2: Reactivos de diagnóstico in vitro para uso profesional. (ISO 18113-2:2009)
in stock
Released: 2012-02-22
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 3: Instrumentos de diagnóstico in vitro para uso profesional. (ISO 18113-3:2009)
in stock
Released: 2012-02-22
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 4: Reactivos de diagnóstico in vitro para autodiagnóstico. (ISO 18113-4:2009)