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Standard ÖNORM EN ISO 11607-2 1.12.2022 preview

ÖNORM EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) (consolidated version)

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STANDARD published on 1.12.2022


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The information about the standard:

Designation standards: ÖNORM EN ISO 11607-2
Publication date standards: 1.12.2022
SKU: NS-1090934
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Sterilized packaging

Annotation of standard text ÖNORM EN ISO 11607-2 :

Dieses Dokument legt Anforderungen für die Entwicklung und Validierung von Verpackungsprozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Steril-barrieresystemen und Verpackungssystemen. Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden. Es deckt nicht alle Anforderungen an Verpackungen aseptisch hergestellter Medizinprodukte ab. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.

These changes apply to this standard:

Preview ÖNORM EN ISO 11607-2/A1 15.3.2024
ÖNORM EN ISO 11607-2/A1 Change

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019/Amd 1:2023) (Amendment)

Change published on 15.3.2024

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