EN 868-9:2009
(Main)Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally
sterilized medical devices to the point of use.
NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.
This part of EN 868 only introduces performance requirements and test methods that are specific to the
products covered by this part of EN 868 but does not add or modify the general requirements specified in
EN ISO 11607-1.
As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying
or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray
liners or an additional envelope around the medical device) then other requirements, including the determination of the
acceptability of these materials during validation activities, may apply.
The materials specified in this part of EN 868 are intended for single use only.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 9: Unbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und Prüfverfahren
Matériaux et systèmes d’emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 9: Matériaux non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai
La présente partie de l’EN 868 fournit des méthodes d'essai et des valeurs relatives aux matériaux non-tissés
à base de polyoléfines, non enduits, utilisés dans des systèmes de barrière stérile préformés et/ou des
systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade
terminal jusqu'à leur utilisation.
NOTE 1 La nécessité d’un emballage protecteur peut être déterminée par le fabricant et l’utilisateur.
La présente partie de l’EN 868 présente uniquement les exigences de performance et les méthodes d’essai
spécifiques des produits couverts par la présente partie de l’EN 868 mais elle n'ajoute pas ou ne modifie pas
les exigences générales spécifiées dans l’EN ISO 11607-1.
En conséquence, les exigences particulières dans les paragraphes 4.2 à 4.3 peuvent être utilisées pour
démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de l’EN ISO 11607-1.
NOTE 2 En cas d'utilisation de matériaux supplémentaires à l’intérieur du système de barrière stérile de manière à
faciliter le rangement, le séchage ou la présentation aseptique (par exemple, enveloppe interne, filtre de conteneur,
indicateurs, listes d’emballage, tapis, dispositifs de rangement des instruments, fonds de paniers ou une enveloppe
supplémentaire entourant le dispositif médical), d’autres exigences peuvent alors s’appliquer, y compris la détermination
de l’acceptabilité de ces matériaux lors des activités de validation.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.
Embalaža za končno sterilizirane medicinske pripomočke - 9. del: Površinsko neobdelani netkani materiali iz poliolefinov - Zahteve in preskusne metode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
1DGRPHãþD
SIST EN 868-9:2001
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNH GHO 3RYUãLQVNR
QHREGHODQLQHWNDQLPDWHULDOLL]SROLROHILQRY=DKWHYHLQSUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven
materials of polyolefines - Requirements and test methods
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte -
Teil 9: Unbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und
Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 9: Non tissés à base de polyoléfines, non enduits, pour la fabrication de
sachets, gaines et opercules thermoscellables - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-9:2009
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 868-9
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-9:2000
English Version
Packaging for terminally sterilized medical devices - Part 9:
Uncoated nonwoven materials of polyolefines - Requirements
and test methods
Matériaux d'emballage pour les dispositifs médicaux Verpackungen für in der Endverpackung zu sterilisierende
stérilisés au stade terminal - Partie 9: Non tissés à base de Medizinprodukte - Teil 9: Unbeschichtete
polyoléfines, non enduits, pour la fabrication de sachets, Faservliesmaterialien aus Polyolefinen - Anforderungen
gaines et opercules thermoscellables - Exigences et und Prüfverfahren
méthodes d'essai
This European Standard was approved by CEN on 23 April 2009.
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. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-9:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Requirements .6
4.1 General .6
4.2 Materials .6
4.3 Performance requirements and test methods .6
4.4 Marking of the protective packaging .6
5 Information to be supplied by the manufacturer .7
Annex A (informative) Details of significant technical changes between this European Standard
and the previous edition .8
Bibliography .9
Foreword
This document (EN 868-9:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
medical purposes”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by November 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 868-9:2000.
Annex A provides details of significant technical changes between this European Standard and the previous
edition.
EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical
devices:
Part 2: Sterilization wrap — Requirements and test methods;
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;
Part 4: Paper bags — Requirements and test methods;
Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test
methods;
Part 6: Paper for low temperature sterilization processes — Requirements and test methods;
Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods;
Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test
methods;
Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods;
Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods.
In addition, ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for
medical purposes" has prepared the EN ISO 11607 series "Packaging for terminally sterilized medical
devices". The EN ISO 11607 series specifies general requirements for materials, sterile barrier systems and
packaging systems (Part 1) and validation requirements for forming, sealing and assembly processes (Part 2).
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Introduction
The EN ISO 11607 series consists of two parts under the general title "Packaging for terminally sterilized
medical devices". Part 1 of this series specifies general requirements and test methods for materials,
preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain
sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation
requirements for forming, sealing and assembly processes.
Every sterile barrier system shall fulfil the requirements of EN ISO 11607-1.
The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in
EN ISO 11607-1.
During the revision of EN 868 parts 2 to 10 CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/2003
relating to the implementation of the uncertainty of measurement concept in standards. Following this
Resolution and the corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods
needed to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that
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