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in stockReleased: 2025-01-22
UNE EN ISO 18113-2:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 2: Reactivos para diagnóstico in vitro para uso profesional. (ISO 18113-2:2022).
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English PDF
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98.35 USD
English Hardcopy
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98.35 USD
Spanish PDF
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98.35 USD
Spanish Hardcopy
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98.35 USD
| Standard number: | UNE EN ISO 18113-2:2025 |
| Pages: | 25 |
| Released: | 2025-01-22 |
| Status: | Standard |
| Pages (Spanish): | 28 |
DESCRIPTION
UNE EN ISO 18113-2:2025
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators and controls intended for professional use. 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 self-testing.