EN 868-5:2009

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

This part of EN 868 provides 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
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.
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 4.5 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
The materials specified in this part of EN 868 are intended for single use only.
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.

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

Dieser Teil von EN 868 enthält Prüfverfahren und Werte für siegelfähige Klarsichtbeutel und -schläuche aus
porösem Material, die entweder EN 868-2, -3, -6, -7, -9 oder -10 entsprechen und aus Kunststoff-Verbundfolie
nach Abschnitt 4 hergestellt werden, und dazu vorgesehen sind, als Sterilbarrieresysteme und/oder
Verpackungssysteme die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum
Anwendungszeitpunkt zu erhalten.
ANMERKUNG 1 Das Erfordernis für eine Schutzverpackung kann durch den Hersteller und den Anwender bestimmt
werden.
Dieser Teil von EN 868 enthält lediglich Leistungsanforderungen und Prüfverfahren, die spezifisch für die
Produkte nach diesem Teil von EN 868 sind, und ergänzt oder modifiziert jedoch nicht die in EN ISO 11607-1
festgelegten allgemeinen Anforderungen.
Die besonderen Anforderungen nach 4.2 bis 4.5 können verwendet werden, um Übereinstimmung mit einer
oder mehreren Anforderungen — aber nicht mit allen Anforderungen — der EN ISO 11607-1 nachzuweisen.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.
ANMERKUNG 2 Wenn zusätzliche Materialien innerhalb des Sterilbarrieresystems verwendet werden, um die
Organisation, die Trocknung oder aseptische Präsentation zu erleichtern (z. B. Innenverpackung, Filter für Sterilisierbehälter,
Indikatoren, Verpackungslisten, Unterlagen, Einsätze für Instrumente, Fächer oder eine zusätzliche Umhüllung
für das Medizinprodukt), dann können andere Anforderungen, einschließlich die Bestimmung der Eignung dieser
Materialien im Rahmen von Validierungsstudien gelten.

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

La présente partie de l’EN 868 fournit des méthodes d’essai et des valeurs relatives aux sachets et gaines
thermoscellables et auto-scellables fabriqués à partir de matériaux poreux, conformément à l'EN 868,
Partie 2, 3, 6, 7, 9 ou 10, et en film plastique, conformément à l’Article 4, utilisés comme systèmes de barrière
stérile et/ou 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 4.5 peuvent être utilisées pour
démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de l’EN ISO 11607-1.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.
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.

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

General Information

• Status: Withdrawn
• Publication Date: 19-May-2009
• Withdrawal Date: 18-Dec-2018
• ICS: 11.080 - Sterilization and disinfection
• ICS: 11.080.30 - Sterilized packaging
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 19-Dec-2018
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 868-5:2009 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

Relations

• Replaces: EN 868-5:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
• Effective Date: 30-May-2009
• Replaces: EN 868-5:1999/AC:2001 - Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
• Effective Date: 30-May-2009
• Replaced By: EN 868-5:2018 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
• Effective Date: 26-Dec-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2009
1DGRPHãþD
SIST EN 868-5:2000
SIST EN 868-5:2000/AC:2002
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO9UHþNHLQ]YLWNL
SDSLUMD]PRåQRVWMRWHVQMHQMDVDPROHSLOQL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
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte -
Teil 5: Siegelfähige Klarsichtbeutel und -schläuche aus porösem Material 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 et auto-scellables en papier et en
film plastique - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-5:2009
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 868-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-5:1999
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 d'emballage pour les dispositifs médicaux Verpackungen für in der Endverpackung zu sterilisierende
stérilisés au stade terminal - Partie 5: Sachets et gaines Medizinprodukte - Teil 5: Siegelfähige Klarsichtbeutel und -
thermoscellables constitués d'une face matière poreuse et schläuche aus porösem Material und Kunststoff-
d'une face film plastique - Exigences et méthodes d'essai Verbundfolie - Anforderungen und Prüfverfahren
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 868-5:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Requirements .6
5 Information to be supplied by the manufacturer .8
Annex A (informative) Details of significant technical changes between this European Standard
and the previous edition . 10
Annex B (normative) Method for the determination of resistance to the intended sterilization
process . 11
Annex C (normative) Method for the determination of pinholes in plastic laminate . 12
Annex D (normative) Method for the determination of the strength of the seal joint for pouches
and reel material . 14
Annex E (normative) Method for the determination of peel characteristics of paper/plastic
laminate products . 16
Annex F (normative) Method for the determination of fibre orientation . 17
Bibliography . 18

Foreword
This document (EN 868-5:2009) 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 868-5:1999.
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 the
information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their
next revisions.
CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse
environmental impacts by standards. It was agreed that this subject should be given priority during the next
edition of the EN ISO 11607 series that is the basic reference for all parts of the series EN 868.
1 Scope
This part of EN 868 provides 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
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.
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 4.5 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
The materials specified in this part of EN 868 are intended for single use only.
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 868-2, Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements
and test methods
EN 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
EN 868-6, Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization
process — Requirements and test methods
EN 868-7, Packaging for terminally sterilized medical devices — Part 7: Adhesive coated paper for low
temperature sterilization processes — Requirements and test methods
EN 868-9, Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of
polyolefines — Requirements and test methods
EN 868-10, Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven
materials of polyolefines — Requirements and test methods
EN ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements
(ISO 11140-1:2005)
EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ASTM D 882:1995, Test Methods for Tensile Properties of the Thin Plastic Sheeting
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 and the following
apply.
3.1
healthcare facility
location where patients are medically treated and/or medical devices are terminally sterilized
EXAMPLE Hospital, dentist office, practitioner.
4 Requirements
4.1 General
The requirements of EN ISO 11607-1 apply.
NOTE 1 EN ISO 11607-1:2006, 5.1.4 refers to conditions during production and handling with respect to their impact
on the product (e.g. electrostatic conductivity, bioburden if applicable).
NOTE 2 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2.
4.2 Materials
4.2.1 Porous material
The porous material shall comply with the requirements of either EN 868 part 2, 3, 6, 7, 9 or 10.
When the porous material is to be used to manufacture preformed sterile barrier systems intended to be
irradiation sterilized only, requirements for wet strength properties or permeability to air need not apply.
4.2.2 Plastic film
4.2.2.1 The plastic fi
...