EN 868-4:2017

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

This draft European Standard provides test methods and values for paper bags manufactured from paper specified in EN 868-3, 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.
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.
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 4: Papierbeutel - Anforderungen und Prüfverfahren

Dieser europäische Norm-Entwurf 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 Verpackungs-systeme die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Die Erfordernis für eine Schutzverpackung darf 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, ergänzt oder modifiziert jedoch nicht die in EN ISO 11607 1 festgelegten allgemeinen Anforderungen.
Die besonderen Anforderungen nach 4.2 bis 4.6 können daher verwendet werden, um Übereinstimmung mit einer oder mehreren Anforderung(en) - aber nicht mit allen Anforderungen - der EN ISO 11607 1 nachzuweisen.
Die in diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.
Werden zusätzliche Materialien im Sterilbarrieresystem verwendet, um die Organisation, die Trocknung oder die aseptische Präsentation zu erleichtern (z. B. Innenverpackung, Filter für Sterilisier¬behälter, Indikatoren, Verpackungslisten, Unterlagen, Einsätze für Instrumente, Fächer oder eine zusätzliche Umhüllung für das Medizinprodukt), dann können andere Anforderungen, einschließlich der Bestimmung der Eignung dieser Materialien im Rahmen von Validierungstätigkeiten, gelten.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4: Sacs en papier - Exigences et méthodes d'essai

Le présent projet de Norme européenne fournit des méthodes d'essai et des valeurs applicables aux sacs en papier fabriqués à partir du papier spécifié dans l’EN 868-3, et utilisés comme systèmes de barrière stérile et/ou comme systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal, jusqu'à leur utilisation.
La nécessité d’un emballage de protection 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 aux 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 mentionnées en 4.2 à 4.6 peuvent être utilisées pour démontrer la conformité à une ou plusieurs exigences de l’EN ISO 11607-1, mais pas à la totalité de ces exigences.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.
En cas d'utilisation de matériaux complémentaires 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, inventaires d’emballage, matelas de support silicone ou autres plastiques, kits d’organisation des instruments médicaux, fonds de protection de panier ou une enveloppe supplémentaire contenant 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 - 4. del: Papirnate vrečke - Zahteve in preskusne metode

Ta osnutek evropskega standarda podaja preskusne metode in vrednosti za papirnate vrečke, izdelane iz papirja, določenega v standardu EN 868-3, ki se uporabljajo kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik.
Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki se uporabljajo 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 4.6 se lahko uporabljajo 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.
Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, filtrirni vsebnik, kazalniki, 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: 07-Feb-2017
• Withdrawal Date: 30-Aug-2017
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Completion Date: 21-Feb-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 868-4:2017 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

Relations

• Replaces: EN 868-4:2009 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
• Effective Date: 15-Feb-2017
• Revised: FprEN 868-4 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
• Effective Date: 26-Feb-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2017
1DGRPHãþD
SIST EN 868-4:2009
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3DSLUQDWHYUHþNH
=DKWHYHLQSUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements
and test methods
Verpackungen 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 868-4:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.080 9UHþH9UHþNH Sacks. Bags
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 868-4
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-4:2009
English Version
Packaging for terminally sterilized medical devices - Part
4: Paper bags - Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungsmaterialien für in der Endverpackung zu
terminal - Partie 4: Sacs en papier - Exigences et sterilisierende Medizinprodukte - Teil 4: Papierbeutel -
méthodes d'essai Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 4 December 2016.

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-CENELEC 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-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.
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. EN 868-4:2017 E
worldwide for CEN national Members.

Contents Page
European 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 . 10
Annex B (normative) Method for the determination of pH value, chloride and sulphate in
paper bags . 11
B.1 Preparation of test pieces . 11
B.2 pH value . 11
B.3 Chloride . 11
B.4 Sulphate . 11
B.5 Test report . 11
Annex C (normative) Method for the determination of the tensile strength of the back seam
joint in paper bags (see 4.5.4) . 12
C.1 Preparation of the test pieces . 12
C.2 Procedure. 12
C.3 Test report . 12
Annex D (informative) Repeatability and Reproducibility of test methods . 13
Bibliography . 14

European foreword
This document (EN 868-4:2017) has been prepared by Technical Committee CEN/TC 102 “Sterilizers
and associated equipment for processing of medical devices”, 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 August 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 868-4:2009.
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 and associated equipment for processing of medical devices” has prepared the series
EN ISO 11607 “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 organisations of the
following countries are bound to implement this European Standard: 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 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.
General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1 and
EN ISO 11607-2.
The EN 868 series can be used to demonstrate compliance with one or more of the requirements
specified in EN ISO 11607-1.
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 EN 868 series.
1 Scope
This European Standard specifies test methods and values for paper bags manufactured from paper
specified in EN 868-3, 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
European Standard.
The materials specified in this part of EN 868 are intended for single use only.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 (20 mm/min) (ISO 1924-2)
EN ISO 11140-1, Sterilization of health care products - Chemical indicators - Part 1: General requirements
(ISO 11140-1)
EN ISO 11607-1:2009+A1:2014, Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-
1:2006+AMD1:2014)
EN ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2)
ISO 6588-2:2012, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot
extraction
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 9197, Paper, board and pulps — Determination of water-soluble chlorides
ISO 9198, Paper, board and pulp — Determination of water-soluble sulfates
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009+A1:2014
apply.
4 Requirements
4.1 General
For any preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1
and EN ISO 11607-2 shall apply.
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 4.5 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
NOTE 1 Compliance to EN 868–4 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-4 shall contain a statement whether EN ISO 11607-1 and
EN ISO 11607-2 are covered.
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, can apply.
4.2 Construction and design
4.2.1 General
4.2.1.1 The bags shall be manufactured from single web paper specified in EN 868-3.
4.2.1.2 The following terms shall be used to describe the design of the bag:
a) back – the surface of the bag with a longitudinal seam;
b) front – the surface of the bag with no longitudinal seam;
c) unlipped – where the length of both the front and back surfaces are the same and the front surface
has a thumb cut (9 ± 3) mm deep and not less than 15 mm wide;
d) lipped –
...