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in stockReleased: 2025-01-22
UNE EN ISO 18113-5:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
Productos sanitarios para diagnóstico in vitro. Información proporcionada por el fabricante (etiquetado). Parte 5: Instrumentos para diagnóstico in vitro para autodiagnóstico. (ISO 18113-5:2022).
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English PDF
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English Hardcopy
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Spanish PDF
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Spanish Hardcopy
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| Standard number: | UNE EN ISO 18113-5:2025 |
| Pages: | 22 |
| Released: | 2025-01-22 |
| Status: | Standard |
| Pages (Spanish): | 23 |
DESCRIPTION
UNE EN ISO 18113-5:2025
This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for self-testing. This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing. This document can also be applied 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.