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Standard ÖNORM EN ISO 18113-5 1.10.2024 preview

ÖNORM EN ISO 18113-5

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

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STANDARD published on 1.10.2024


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The information about the standard:

Designation standards: ÖNORM EN ISO 18113-5
Publication date standards: 1.10.2024
SKU: NS-1199364
The number of pages: 23
Approximate weight : 69 g (0.15 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 18113-5 :

Dieses Dokument legt Anforderungen an die durch den Hersteller von in-vitro-diagnostischen (IVD-)Geräten für Untersuchungen zur Eigenanwendung bereitgestellten Informationen fest. Dieses Dokument ist anwendbar auch für Geräte und Ausrüstungen, die für den Gebrauch zusammen mit IVD-Geräten für Untersuchungen zur Eigenanwendung vorgesehen sind. Dieses Dokument kann auch auf Zubehör angewendet werden. Dieses Dokument ist nicht anwendbar für: a) Anweisungen für die Geräteinstandhaltung oder -reparatur; b) IVD-Reagenzien, einschließlich Kalibriermaterialien und Kontrollmaterialien zur Kontrolle des Reagenzes; c) IVD-Geräte für den Gebrauch durch Fachpersonal.

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