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Standard ÖNORM EN ISO 18113-4 1.10.2024 preview

ÖNORM EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

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STANDARD published on 1.10.2024


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The information about the standard:

Designation standards: ÖNORM EN ISO 18113-4
Publication date standards: 1.10.2024
SKU: NS-1199363
The number of pages: 24
Approximate weight : 72 g (0.16 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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The category - similar standards:

In vitro diagnostic test systems

Annotation of standard text ÖNORM EN ISO 18113-4 :

Dieses Dokument legt Anforderungen an die durch den Hersteller von in-vitro-diagnostischen (IVD-)Reagenzien, -Kalibriermaterialien und -Kontrollmaterialien für Untersuchungen zur Eigenanwendung bereitgestellten Informationen fest. Dieses Dokument kann auch auf Zubehör angewendet werden. Dieses Dokument ist anwendbar für Etiketten für die äußeren und Primärbehälter sowie für die Gebrauchsanleitung. Dieses Dokument ist nicht anwendbar für: a) IVD-Geräte oder Ausrüstungen; b) IVD-Reagenzien für den Gebrauch durch Fachpersonal.

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