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Standard ČSN EN IEC 60601-2-39-ed.3 1.8.2019 preview

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ČSN EN IEC 60601-2-39-ed.3 (364801)

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

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STANDARD published on 1.8.2019


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The information about the standard:

Designation standards: ČSN EN IEC 60601-2-39-ed.3
Classification mark: 364801
Catalog number: 508025
Publication date standards: 1.8.2019
SKU: NS-955224
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 IEC 60601-2-39-ed.3 (364801):

definuje zvláštní požadavky na bezpečnost a funkčnost přístrojů pro peritoneální dialýzu. Platí pro přístroje určené pro použití zdravotnickým personálem nebo pod odborným zdravotnickým dohledem, včetně přístrojů ovládaných pacientem, bez ohledu na to, zda jsou používány v nemocničním nebo domácím prostředí. Neplatí však pro dialyzační roztok nebo pro okruh dialyzačního roztoku. Problematika bezpečnosti i funkčnosti (tok dialyzačního roztoku do pacienta, tok dialyzačního roztoku z pacienta, dodržování a přesnost bilance objemu napouštění/vypouštění, složení dialyzačního roztoku, teplota dialyzátu) je zde charakterizována zejména riziky z napojení pacienta na mimotělní okruh. Norma má význam nejen pro výrobce a obchodní organizace, je vhodná i pro dialyzační pracoviště. Toto třetí vydání normy obsahuje důležité technické změny, např. aktualizaci odkazů na změněnou základní normu a skupinové normy, doplnění článků týkajících se nezbytné funkčnosti a nové požadavky na provoz při výpadku napájecí sítě

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