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in stockReleased: 2025-01-22
UNE EN ISO 18113-4:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 4: Reactivos para diagnóstico in vitro para autodiagnóstico. (ISO 18113-4:2022).
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English Hardcopy
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| Standard number: | UNE EN ISO 18113-4:2025 |
| Pages: | 25 |
| Released: | 2025-01-22 |
| Status: | Standard |
DESCRIPTION
UNE EN ISO 18113-4:2025
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators, and controls intended for self-testing. This document can also be applied to accessories. This document applies 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.