Norm

NEN-EN 868-5:2007 Ontw. en

Verpakkingsmateriaal voor te steriliseren medische hulpmiddelen - Deel 5: Af te sluiten zakken en spoelen van poreus materiaal en plastic film constructie - Eisen en beproevingsmethoden

  • Deze norm is ingetrokken sinds 04-06-2009

23,50

Over deze norm

Status Ingetrokken
Aantal pagina's 12
Gepubliceerd op 01-09-2007
Taal Engels
This Part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868-3, -6, -7, -9 or -10 and plastic film complying with clause 4 of this Draft European standard. This Part of EN 868 introduces no additional requirements to the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Sealable pouches and reels specified in this part of EN 868 are suitable for use as packaging of medical devices which are to be terminally sterilized. The use of sealable pouches and reels as preformed sterile barrier systems enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened.

Details

ICS-code 11.080.30
55.040
Nederlandse titel Verpakkingsmateriaal voor te steriliseren medische hulpmiddelen - Deel 5: Af te sluiten zakken en spoelen van poreus materiaal en plastic film constructie - Eisen en beproevingsmethoden
Engelse titel Packaging materials for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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