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Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Oznaka:prEN 868-8
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 re-usable containers used as sterile barrier systems for terminally sterilized medical devices. These containers are intended to be used in large steam sterilizers as specified in EN 285.
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.
This document does not cover additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device).

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