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prEN 868-6

(Main)

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes.
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.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6: Papier zur Sterilisation mit Sterilisationsverfahren mit niedriger Temperatur - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für Papier zur Herstellung von vorgefertigten Sterilbarrieresystemen und/oder Verpackungssystemen zum Einmalgebrauch fest, die für in der Endverpackung zu sterilisierende Medizinprodukte mittels Niedertemperatur-Sterilisationsverfahren verwendet werden.
Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607-1 und EN ISO 11607-2 [2] festgelegt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, welche spezifisch für die in diesem Dokument betrachteten Produkte sind.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 6 : Papier pour la fabrication d'emballages à usage médical pour stérilisation par l'oxyde d'éthylène ou par irradiation - Exigences et méthodes d'essai

Le présent document spécifie des méthodes d’essai et des valeurs applicables au papier utilisé dans la fabrication des systèmes de barrière stérile et/ou systèmes d’emballage à usage unique destinés à des dispositifs médicaux stérilisés au stade terminal au moyen de procédés de stérilisation à basse température.
Mis à part les exigences générales spécifiées dans l’EN ISO 11607-1 et l’EN ISO 11607-2 [2], la présente partie de l’EN 868 spécifie les matériaux, les méthodes d’essai et les valeurs spécifiques aux produits couverts par le présent document.

Embalaža za končno sterilizirane medicinske pripomočke - 6. del: Papir za sterilizacijske procese z nizko temperaturo - Zahteve in preskusne metode

General Information

Status
Not Published
Publication Date
16-Jun-2025
ICS
11.080.30 - Sterilized packaging
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 4 - Packaging materials
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
11-Apr-2024
Due Date
16-Jan-2024
Completion Date
11-Apr-2024
Ref Project
oSIST prEN 868-6:2024 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

Relations

Revises
EN 868-6:2017 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Effective Date
26-Feb-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 868-6:2024
01-junij-2024
Embalaža za končno sterilizirane medicinske pripomočke - 6. del: Papir za
sterilizacijske procese z nizko temperaturo - Zahteve in preskusne metode
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature
sterilization processes - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6:
Papier zur Sterilisation mit Sterilisationsverfahren mit niedriger Temperatur -
Anforderungen und Prüfverfahren
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 6 : Papier pour
la fabrication d'emballages à usage médical pour stérilisation par l'oxyde d'éthylène ou
par irradiation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-6
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.040 Materiali in pripomočki za Packaging materials and
pakiranje accessories
oSIST prEN 868-6:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 868-6:2024

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oSIST prEN 868-6:2024


DRAFT
EUROPEAN STANDARD
prEN 868-6
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2024
ICS 11.080.30 Will supersede EN 868-6:2017
English Version

Packaging for terminally sterilized medical devices - Part
6: Paper for low temperature sterilization processes -
Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 6 : Papier pour la fabrication sterilisierende Medizinprodukte - Teil 6: Papier zur
d'emballages à usage médical pour stérilisation par Sterilisation mit Sterilisationsverfahren mit niedriger
l'oxyde d'éthylène ou par irradiation - Exigences et Temperatur - Anforderungen und Prüfverfahren
méthodes d'essai
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 102.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-6:2024 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 868-6:2024
prEN 868-6:2024 (E)
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements . 7
5 Performance requirements and test methods . 7
6 Sterilizati
...

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