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Standard ÖNORM EN ISO 13408-1 15.10.2024 preview

ÖNORM EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

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STANDARD published on 15.10.2024


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The information about the standard:

Designation standards: ÖNORM EN ISO 13408-1
Publication date standards: 15.10.2024
SKU: NS-1204078
The number of pages: 97
Approximate weight : 322 g (0.71 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 13408-1 :

Dieses Dokument legt die allgemeinen Anforderungen an Verfahren, Programme und Verfahrensweisen zur Entwicklung, Validierung und routinemäßigen Kontrolle der aseptischen Herstellung von Produkten für die Gesundheitsfürsorge fest und stellt einen Leitfaden dafür zur Verfügung. Dieses Dokument umfasst Anforderungen und einen Leitfaden in Bezug auf das Gesamtthema der aseptischen Herstellung. Besondere Anforderungen und ein Leitfaden für verschiedene spezielle Prozesse und Verfahren in Bezug auf Sterilfiltration, Lyophilisierung, Technologien der Reinigung vor Ort (en: cleaning in place, CIP), Sterilisation vor Ort (en: sterilization in place, SIP) und Isolatorensysteme sind in den anderen Teilen der Normenreihe ISO 13408 angeführt.

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