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Standard ČSN EN ISO 11607-2 1.6.2020 preview

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ČSN EN ISO 11607-2 (855280)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

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STANDARD published on 1.6.2020


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The information about the standard:

Designation standards: ČSN EN ISO 11607-2
Classification mark: 855280
Catalog number: 510229
Publication date standards: 1.6.2020
SKU: NS-994072
The number of pages: 20
Approximate weight : 60 g (0.13 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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The category - similar standards:

Sterilized packaging

Annotation of standard text ČSN EN ISO 11607-2 (855280):

Tento norma specifikuje požadavky na vývoj a validaci procesů pro balení zdravotnických prostředků, které se sterilizují v konečném obalu. Tyto procesy zahrnují tváření, utěsnění a sestavení předem vytvořených sterilních bariérových systémů, sterilních bariérových systémů a obalových systémů. Norma má široké použití v průmyslu, zařízeních poskytujících zdravotní péči, a kdekoli se zdravotnické prostředky balí a sterilizují

These changes apply to this standard:

Preview ČSN EN ISO 11607-2:2020/A11 1.12.2022
ČSN EN ISO 11607-2:2020/A11 (855280) Change

Obaly pro zdravotnické prostředky sterilizované v konečném obalu - Část 2: Požadavky na validaci procesů tváření, utěsnění a sestavení.

Change published on 1.12.2022

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Preview ČSN EN ISO 11607-2:2020/A1 1.5.2024
ČSN EN ISO 11607-2:2020/A1 (855280) Change

Obaly pro zdravotnické prostředky sterilizované v konečném obalu - Část 2: Požadavky na validaci procesů tváření, utěsnění a sestavení.

Change published on 1.5.2024

Selected format:
Czech -
Print design (10.80 USD)


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10.80 USD


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Preview of the standard ČSN EN ISO 11607-2 (855280)

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