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Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels constructed of porous materials and plastic film - Requirements and test methods
Oznaka:prEN 868-5
Odbor:HZN/TO 555
Ime odbora:Medicinski proizvodi
Nacrt objavljen za komentiranje:2026-02-06
Rok za komentiranje:2026-03-09
Broj komentara:0
Contact email:nacrti(at)hzn.hr
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This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

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