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Standard ČSN EN ISO 22442-3 1.12.2008 preview

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ČSN EN ISO 22442-3 (857501)

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents



STANDARD published on 1.12.2008


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The information about the standard:

Designation standards: ČSN EN ISO 22442-3
Classification mark: 857501
Catalog number: 82221
Publication date standards: 1.12.2008
SKU: NS-167511
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

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Annotation of standard text ČSN EN ISO 22442-3 (857501):

stanovuje požadavky na validaci eliminace a/nebo inaktivace virů a agens TSE v průběhu výroby zdravotnických prostředků (s výjimkou diagnostických zdravotnických prostředků in vitro) používajících živočišné tkáně nebo produkty odvozené z živočišné tkáně, které nejsou životaschopné nebo byly umrtveny. Platí tam, kde to vyžaduje proces řízení rizika, jak je popsáno v ISO 22442-1. Nevztahuje se na jiná přenosná nebo nepřenosná agens.

Preview of the standard ČSN EN ISO 22442-3 (857501)

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Latest update: 2024-04-25 (Number of items: 2 896 007)
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