Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Comment end date 2026-03-24

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Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas

2. Projektas

3. Viešoji apklausa

From 2026-01-23 till 2026-03-24

4. Closure of enquiry

5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.080.30 - Sterilized packaging

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 102

Number of comments

Comment start date

2026-01-23

Scope

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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Pakeis

prEN 868-8