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oSIST prEN 868-3:2024

(Main)

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

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

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.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für Papier zur Herstellung von Einweg-Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Einweg-Klarsichtbeuteln und  schläuchen (festgelegt in EN 868-5) fest, die verwendet werden als Sterilbarrieresysteme und/oder Verpackungssysteme für in der Endverpackung zu sterilisierende Medizinprodukte, die durch Sterilisationsverfahren sterilisiert werden, die Eigenschaften erfordern, welche für die Sterilisation bei höherer Temperatur spezifisch sind, wie z. B. die in Gesundheitseinrichtungen angewendete Sterilisation durch feuchte Hitze.
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.

Emballage des dispositifs médicaux stérilisés au stade terminal - Partie 3 : Papier utilisé dans la fabrication de sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5) - Exigences et méthodes d'essai

Le présent document spécifie des méthodes d’essai et des valeurs applicables au papier utilisé dans la fabrication des sacs en papier à usage unique (spécifiés dans l’EN 868-4) et dans la fabrication de sachets et gaines à usage unique (spécifiés dans l’EN 868-5), employés comme systèmes de barrière stérile et/ou systèmes d’emballage pour des dispositifs médicaux stérilisés au stade terminal par des procédés de stérilisation requérant des propriétés spécifiques de stérilisation à haute température (par exemple, la stérilisation à chaleur humide utilisée dans les établissements de santé).
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 - 3. del: Papir za izdelavo papirnatih vrečk (specifikacija EN 868-4) in papir za izdelavo vrečk in zvitkov (specifikacija EN 868-5) - 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 868-3 - 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

Relations

Revises
SIST EN 868-3:2017 - 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
Effective Date
26-Feb-2023

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SLOVENSKI STANDARD
oSIST prEN 868-3:2024
01-junij-2024
Embalaža za končno sterilizirane medicinske pripomočke - 3. del: Papir za
izdelavo papirnatih vrečk (specifikacija EN 868-4) in papir za izdelavo vrečk in
zvitkov (specifikacija EN 868-5) - Zahteve in preskusne metode
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
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3:
Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung
von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und
Prüfverfahren
Emballage des dispositifs médicaux stérilisés au stade terminal - Partie 3 : Papier utilisé
dans la fabrication de sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de
sachets et gaines (spécifiés dans l'EN 868-5) - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-3
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.080 Vreče. Vrečke Sacks. Bags
oSIST prEN 868-3:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 868-3:2024

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oSIST prEN 868-3:2024


DRAFT
EUROPEAN STANDARD
prEN 868-3
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2024
ICS 11.080.30 Will supersede EN 868-3:2017
English Version

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
Emballage des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 3 : Papier utilisé dans la fabrication de sterilisierende Medizinprodukte - Teil 3: Papier zur
sacs en papier (spécifiés dans l'EN 868-4) et dans la Herstellung von Papierbeuteln (festgelegt in EN 868-4)
fabrication de sachets et gaines (spécifiés dans l'EN und zur Herstellung von Klarsichtbeuteln und -
868-5) - Exigences et méthodes d'essai schläuchen (festgelegt in EN 868-5) - 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 868-3:2024 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 868-3:2024
prEN 868-3:2024 (E)
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and defin
...

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