International Standard
ISO 18113-5:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Reference number
ISO 18113-5:2022
ISO 18113-5:2022
Edición 2
2022-10
2022-10
© ISO 2024
International Standard
Resumen
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.
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: 10
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Comité Técnico :ISO/TC 212ICS :11.100.10
- RSS actualizaciones
Ciclo de vida
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Anteriormente
RetiradaISO 18113-5:2009
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Ahora
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