DIN EN ISO 18113-4:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022); German version EN ISO 18113-4:2024
| Fecha edición: |
2024-10-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Furthermore, this part of DIN EN ISO 18113 applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate. This part of DIN EN ISO 18113 applies to labels for the outer and immediate container and to the instructions for use. |
| Keywords: | Apparatus for analysis|Applications|CE marking|Data of the manufacturer|Diagnosis (medical)|Diagnostic equipment|Diagnostic systems|Enterprises|In vitro|Information|Instructions for use|Investigations|In-vitro diagnostic|Labelling|Labels|Laboratory medicine|Marking of roads|Medical equipment|Medical sciences|Medical technology|Operational instructions|Reagents|Self-testing|Specification (approval)|User information |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 18113-4:2024 Idéntica ISO 18113-4:2022 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 18113-4:2013-01 Reemplaza a DIN EN ISO 18113-4:2021-09 |
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