SIST EN 868-4:2009

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

This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in Part 3 of this standard 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 4.6 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.

Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 4: Papierbeutel - Anforderungen und Prüfverfahren

Dieser Teil von EN 868 enthält Prüfverfahren und Werte für Papierbeutel, die aus Papier nach Teil 3 von
EN 868 hergestellt wurden, 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 4.6 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 4: Sacs en papier - Exigences et méthodes d'essai

Cette Partie de l’EN 868 présente des méthodes d'essai et des valeurs pour les sacs en papier fabriqués à partir de papier spécifié dans la Partie 3 de la présente norme.
Cette partie de l'EN 868 n'introduit pas d'exigences supplémentaires par rapport aux exigences générales spécifiées dans l'EN ISO 11607-1.
Les exigences particulières dans les paragraphes 4.2 à 4.6 peuvent être utilisées pour démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de l’EN ISO 11607-1.
Les sacs en papier spécifiés dans cette partie sont adaptés pour utilisation en tant qu'emballage de dispositifs médicaux qui doivent être stérilisés au stade terminal.

Embalaža za končno sterilizirane medicinske pripomočke - 4. del: Papirnate vrečke - Zahteve in preskusne metode

General Information

• Status: Withdrawn
• Publication Date: 09-Sep-2009
• Withdrawal Date: 27-Feb-2017
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 27-Feb-2017
• Due Date: 22-Mar-2017
• Completion Date: 28-Feb-2017
• 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: EN 868-4:2009 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Relations

• Replaced By: SIST EN 868-4:2017 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
• Effective Date: 01-Apr-2017
• Replaces: SIST EN 868-4:2000 - Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods
• Effective Date: 01-Oct-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 868-4:2009
01-oktober-2009
1DGRPHãþD
SIST EN 868-4:2000
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3DSLUQDWHYUHþNH
=DKWHYHLQSUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements
and test methods
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte -
Teil 4: Papierbeutel - Anforderungen und Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 4: Sacs en papier - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-4:2009
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN 868-4:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 868-4:2009

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SIST EN 868-4:2009
EUROPEAN STANDARD
EN 868-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-4:1999
English Version
Packaging for terminally sterilized medical devices - Part 4:
Paper bags - Requirements and test methods
Matériaux d'emballage pour les dispositifs médicaux Verpackungen für in der Endverpackung zu sterilisierende
stérilisés au stade terminal - Partie 4: Sacs en papier - Medizinprodukte - Teil 4: Papierbeutel - Anforderungen und
Exigences et méthodes d'essai 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 868-4:2009: E
worldwide for CEN national Members.

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SIST EN 868-4:2009
EN 868-4:2009 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
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 .9
Annex B (normative) Method for the determination of ph value, chloride and sulphate in paper
bags . 10
Annex C (normative) Method for the determination of the tensile strength of the back seam joint
in paper bags (see 4.5.4) . 11
Bibliography . 12

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SIST EN 868-4:2009
EN 868-4:2009 (E)
Foreword
This document (EN 868-4:2009) 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 868-4:1999.
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.
3

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SIST EN 868-4:2009
EN 868-4:2009 (E)
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.
4

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SIST EN 868-4:2009
EN 868-4:2009 (E)
1 Scope
This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in
Part 3 of EN 868, 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 4.6 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 868–3, 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 ISO 1924-2, Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation
method (ISO 1924-2:1994)
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 device
...