Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4. These sealable pouches and reels are used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
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.
The materials specified in this part of EN 868 are intended for single use only.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für siegelfähige Klarsichtbeutel und  schläuche aus porösem Material fest, die entweder EN 868 Teil 2, Teil 3, Teil 6, Teil 7, Teil 9 oder Teil 10 entsprechen und aus Kunst¬stoff Verbundfolie nach Abschnitt 4 hergestellt werden. Diese siegelfähigen Klarsichtbeutel und  schläuche werden als Sterilbarrieresysteme und/oder Verpackungssysteme verwendet, die dafür bestimmt sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
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, die spezifisch für die in diesem Dokument betrachteten Produkte sind.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 5: Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique - Exigences et méthodes d'essai

Le présent document spécifie des méthodes d’essai et des valeurs relatives aux sachets et gaines scellables fabriqués à partir de matériaux poreux conformes à l’EN 868, Partie 2, 3, 6, 7, 9 ou 10, et en film plastique, conformément à l’Article 4. Ces sachets et gaines scellables servent de systèmes de barrière stérile et/ou de systèmes d’emballage destinés à maintenir l’état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu’au point d’utilisation.
Outre les exigences générales telles que 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 traités dans le présent document.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.

Embalaža za končno sterilizirane medicinske pripomočke - 5. del: Vrečke in zvitki papirja z možnostjo tesnjenja (samolepilni) iz poroznega materiala in s plastičnimi folijami - Zahteve in preskusne metode

Ta del standarda EN 868 podaja preskusne metode in vrednosti za vrečke in zvitke iz poroznega materiala z možnostjo tesnjenja, izdelane v skladu s standardom EN 868, deli 2, 3, 6, 7, 9 ali 10, in plastične folije v skladu s točko 4, ki se uporabljajo kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
OPOMBA 1: Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik. Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki veljajo za proizvode, zajete v tem delu standarda EN 868, vendar ne dodaja ali spreminja splošnih zahtev, podanih v standardu EN ISO 11607-1.
Posebne zahteve iz točk od 4.2 do 4.5 je mogoče uporabiti za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.
OPOMBA 2: Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, kazalniki filtrov, embalažni listi, podloge, kompleti organizatorjev za inštrumente, obloge za pladnje ali dodatni ovoj okoli medicinskega pripomočka), se lahko uporabljajo druge zahteve, vključno z ugotavljanjem sprejemljivosti teh materialov med preverjanjem.

General Information

Status
Published
Publication Date
18-Dec-2018
Withdrawal Date
29-Jun-2019
Current Stage
9020 - Submission to 2 Year Review Enquiry - Review Enquiry
Start Date
15-Jan-2024
Completion Date
15-Jan-2024

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie - Anforderungen und PrüfverfahrenEmballages des dispositifs médicaux stérilisés au stade terminal - Partie 5: Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique - Exigences et méthodes d'essaiPackaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods11.080.30Sterilizirana embalažaSterilized packagingICS:Ta slovenski standard je istoveten z:EN 868-5:2018SIST EN 868-5:2019en,fr,de01-marec-2019SIST EN 868-5:2019SLOVENSKI
STANDARDSIST EN 868-5:20091DGRPHãþD



SIST EN 868-5:2019



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 868-5
December
t r s z ICS
s sä r z rä u r Supersedes EN
z x zæ wã t r r {English Version
Packaging for terminally sterilized medical devices æ Part
wã Sealable pouches and reels of porous materials and plastic film construction æ Requirements and test methodsEmballages des dispositifs médicaux stérilisés au stade terminal æ Partie
wã Sachets et gaines scellables constitués d 5une face matière poreuse et d 5une face film plastique æ Exigences et méthodes d 5essai
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte æ Teil
wã Siegelfähige Klarsichtbeutel und æschläuche aus porösen Materialien und KunststoffæVerbundfolie æ Anforderungen und Prüfverfahren This European Standard was approved by CEN on
t r August
t r s zä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
9
t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
z x zæ wã t r s z ESIST EN 868-5:2019



EN 868-5:2018 (E) 2 Contents Page European foreword . 3 Introduction . 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 6 4 Requirements . 7 4.1 General . 7 4.2 Materials . 7 4.2.1 Porous material . 7 4.2.2 Plastic film . 7 4.3 Construction and design . 8 4.4 Process indicator .
...

SLOVENSKI STANDARD
oSIST prEN 868-5:2017
01-oktober-2017
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO9UHþNHLQ]YLWNL
SDSLUMD]PRåQRVWMRWHVQMHQMD VDPROHSLOQL L]SRUR]QHJDPDWHULDODLQVSODVWLþQLPL
IROLMDPL=DKWHYHLQSUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels
of porous materials and plastic film construction - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 5:
Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-
Verbundfolie - Anforderungen und Prüfverfahren
Matériaux et systèmes d’emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 5 : Sachets et gaines thermoscellables constitués d'une face matière
poreuse et d'une face film plastique - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-5
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN 868-5:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 868-5:2017

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oSIST prEN 868-5:2017


DRAFT
EUROPEAN STANDARD
prEN 868-5
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2017
ICS 11.080.30 Will supersede EN 868-5:2009
English Version

Packaging for terminally sterilized medical devices - Part
5: Sealable pouches and reels of porous materials and
plastic film construction - Requirements and test methods
Matériaux et systèmes d'emballage pour les dispositifs Verpackungen für in der Endverpackung zu
médicaux stérilisés au stade terminal - Partie 5 : sterilisierende Medizinprodukte - Teil 5: Siegelfähige
Sachets et gaines thermoscellables constitués d'une Klarsichtbeutel und -schläuche aus porösen
face matière poreuse et d'une face film plastique - Materialien und Kunststoff-Verbundfolie -
Exigences et 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-5:2017 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 868-5:2017
prEN 868-5:2017 (E)
Contents Page

European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements .
...

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