DIN EN ISO 18113-1:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022); German version EN ISO 18113-1:2024
| Fecha edición: |
2024-10-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This Standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. |
| Keywords: | Apparatus for analysis|Applications|CE marking|Data of the manufacturer|Definitions|Diagnosis (medical)|Diagnostic equipment|Diagnostic systems|Enterprises|Experts|In vitro|Information|Information supplied by the manufacturer|Inscription|Instructions for use|Investigations|In-vitro diagnostic|Labelling|Laboratory medicine|Marking|Medical equipment|Medical products|Medical sciences|Medical technology|Operational instructions|Product information|Self-testing|Specification (approval)|Terminology|User information|Vocabulary |
| ICS: | 01.040.11 - Tecnología sanitaria (Vocabularios), 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 18113-1:2024 Idéntica ISO 18113-1:2022 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 18113-1:2013-01 Reemplaza a DIN EN ISO 18113-1:2021-09 |
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