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Standard ÖNORM EN 14180 1.8.2025 preview

ÖNORM EN 14180

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

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STANDARD published on 1.8.2025


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The information about the standard:

Designation standards: ÖNORM EN 14180
Publication date standards: 1.8.2025
SKU: NS-1228144
The number of pages: 128
Approximate weight : 415 g (0.91 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Sterilizing equipment

Annotation of standard text ÖNORM EN 14180 :

Dieses Dokument legt Anforderungen und Prüfverfahren für NTDF Sterilisatoren fest, in denen als Sterilisiermittel ein Gemisch von Niedertemperatur-Dampf und Formaldehyd angewendet wird und die nur unterhalb des Umgebungsdrucks arbeiten. Diese Sterilisatoren werden in erster Linie in medizinischen Einrichtungen zur Sterilisation hitzeempfindlicher Medizinprodukte verwendet. Dieses Dokument legt Mindestanforderungen zu folgenden Punkten fest: - für die Leistung und Konstruktion von Sterilisatoren, um ein NTDF Verfahren bereitzustellen, das in der Lage ist, Medizinprodukte zu sterilisieren; - an die Ausrüstung und Bedienelemente dieser Sterilisatoren, die für den Betrieb, die Steuerung und Überwachung der Sterilisationsverfahren erforderlich sind und welche bei der Validierung der Sterilisationsverfahren angewendet werden können. Dieses Dokument legt weitere Prüfgeräte und Prüfverfahren fest, um die Konformität der Ausrüstungskonstruktion und der nach diesem Dokument festgelegten Leistung zu verifizieren. Dieses Dokument legt keine Anforderungen an und Prüfungen für Dekontaminationssysteme zur Verwendung in Räumen, umschlossenen Räumen oder umgebenden Räumen fest.

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