Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods

Comment end date 2024-06-29

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Project stage codes

1. Nauja darbo tema

2. Projektas

3. Viešoji apklausa

From 2024-04-18 till 2024-06-29

4. Closure of enquiry

5. Projekto priėmimas

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

2024-04-18

Scope

This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4) and in the manufacture of single-use pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

Relations

Pakeis

prEN 868-3