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oSIST prEN 868-4:2024

(Main)

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, 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 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 4: Papierbeutel - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für Papierbeutel zum Einmalgebrauch fest, die aus Papier nach EN 868-3 hergestellt wurden und als Sterilbarrieresysteme und/oder Verpackungssysteme für in der Endverpackung zu sterilisierende Medizinprodukte verwendet werden.
Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607-1 und EN ISO 11607-2 festgelegt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, welche spezifisch für die in diesem Dokument betrachteten Produkte sind.

Emballage des dispositifs médicaux stérilisés au stade terminal - Partie 4 : Sacs en papier - Exigences et méthodes d'essai

Le présent document spécifie des méthodes d’essai et des valeurs applicables aux sacs en papier à usage unique, fabriqués à partir du papier spécifié dans l’EN 868-3 et utilisés comme systèmes de barrière stérile et/ou comme systèmes d’emballage pour des dispositifs médicaux stérilisés au stade terminal.
Mis à part les exigences générales spécifiées dans l’EN ISO 11607-1 et l’EN ISO 11607-2, 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 - 4. del: Papirnate vrečke - Zahteve in preskusne metode

General Information

Status
Not Published
Public Enquiry End Date
29-Jun-2024
ICS
11.080.30 - Sterilized packaging
55.080 - Sacks. Bags
Technical Committee
VAZ - Healthcare
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
18-Apr-2024
Due Date
05-Sep-2024
Ref Project
prEN 868-4 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Relations

Revises
SIST EN 868-4:2017 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
Effective Date
26-Feb-2023

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SLOVENSKI STANDARD
oSIST prEN 868-4:2024
01-junij-2024
Embalaža za končno sterilizirane medicinske pripomočke - 4. del: Papirnate vrečke
- Zahteve in preskusne metode
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements
and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 4:
Papierbeutel - Anforderungen und Prüfverfahren
Emballage des dispositifs médicaux stérilisés au stade terminal - Partie 4 : Sacs en
papier - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-4
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.080 Vreče. Vrečke Sacks. Bags
oSIST prEN 868-4:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 868-4:2024

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oSIST prEN 868-4:2024


DRAFT
EUROPEAN STANDARD
prEN 868-4
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2024
ICS 11.080.30 Will supersede EN 868-4:2017
English Version

Packaging for terminally sterilized medical devices - Part
4: Paper bags - Requirements and test methods
Emballage des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 4 : Sacs en papier - Exigences et sterilisierende Medizinprodukte - Teil 4: Papierbeutel -
méthodes d'essai Anforderungen und Prüfverfahren
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 868-4:2024 E
worldwide for CEN national Members.

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oSIST prEN 868-4:2024
prEN 868-4:2024 (E)
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 General requirements . 7
5 Construction and design . 7
5.1 General. 7
5.2 Bottom seal formation . 8
5.3 Back seam construction. 8
5.4 Process indicator .
...

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