Resumen
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
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Informaciones generales
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Estado: PublicadoFecha de publicación: 2022-10Etapa: Norma Internacional publicada [60.60]
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Edición: 2Número de páginas: 11
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Comité Técnico :ISO/TC 212ICS :11.100.10
- RSS actualizaciones
Ciclo de vida
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Anteriormente
RetiradaISO 18113-4:2009
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Ahora
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