DIN EN ISO 18113-2:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024
| Fecha edición: |
2024-10-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of the DIN EN ISO 18113 series specifies requirements for information provided by the manufacturer of IVD reagents, calibrators and controls for professional use. Where applicable, this draft standard may also be applied to accessories. This part of DIN EN ISO 18113 applies to labels for the outer and primary containers and the instructions for use. |
| Keywords: | Abstracts|Accessories|Apparatus for analysis|Applications|CE marking|Data of the manufacturer|Diagnosis|Diagnostic equipment|Diagnostic systems|Enterprises|Experts|In vitro|Information|Information supplied by the manufacturer|Instructions for use|Investigations|In-vitro diagnostic|Labelling|Labels|Laboratory medicine|Marking|Marking of roads|Medical equipment|Medical products|Medical sciences|Medical technology|Occupational safety|Operational instructions|Packages|Personnel|Product information|Reagents|Specification (approval)|User information|Workplace safety |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 18113-2:2024 Idéntica ISO 18113-2:2022 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 18113-2:2013-01 Reemplaza a DIN EN ISO 18113-2:2021-09 |
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