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Standard ÖNORM EN ISO 13408-6 15.10.2021 preview

ÖNORM EN ISO 13408-6

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

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STANDARD published on 15.10.2021


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The information about the standard:

Designation standards: ÖNORM EN ISO 13408-6
Publication date standards: 15.10.2021
SKU: NS-1040889
The number of pages: 42
Approximate weight : 126 g (0.28 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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The category - similar standards:

Sterilization and disinfection in general

Annotation of standard text ÖNORM EN ISO 13408-6 :

Dieses Dokument legt die Anforderungen für Isolatorensysteme fest und stellt einen Leitfaden zur Spezifikation, Auswahl, Qualifizierung, Biodekontamination, Validierung, zum Betrieb und zur Kontrolle von Isolatorensystemen im Zusammenhang mit der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge und der Herstellung von zellbasierten Produkten für die Gesundheitsfürsorge zur Verfügung. Dieses Dokument legt keine Anforderungen für Barrieresysteme mit beschränktem Zugang (RABS, en: restricted access barrier system) fest. Dieses Dokument ersetzt keine nationalen behördlichen Anforderungen, wie z. B. Gute Herstellungspraktiken (GMP, en: Good Manufacturing Practices) und/oder Anforderungen von Arzneibüchern, die insbesondere nationale oder regionale Zuständigkeiten betreffen. Dieses Dokument legt keine Anforderungen für Isolatoren fest, die für Sterilitätsprüfungen verwendet werden, jedoch könnten einige der Grundsätze und Angaben in diesem Dokument auf diese Anwendung anwendbar sein. Dieses Dokument legt keine Eindämmungsanforderungen für die Biosicherheit fest.

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