EN 868-10:2018

SLOVENSKI STANDARD
01-marec-2019
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SIST EN 868-10:2009
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Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven
materials of polyolefines - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 10:
Klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und
Prüfverfahren
Matériaux et systèmes d’emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 10 : Matériaux non tissés à base de polyoléfines enduits d’adhésif -
Exigences et méthodes d’essai
Ta slovenski standard je istoveten z: EN 868-10:2018
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 868-10
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-10:2009
English Version
Packaging for terminally sterilized medical devices - Part
10: Adhesive coated nonwoven materials of polyolefines -
Requirements and test methods
Matériaux et systèmes d'emballage pour les dispositifs Verpackungen für in der Endverpackung zu
médicaux stérilisés au stade terminal - Partie 10 : sterilisierende Medizinprodukte - Teil 10:
Matériaux non tissés à base de polyoléfines enduits Klebemittelbeschichtete Faservliesmaterialien aus
d'adhésif - Exigences et méthodes d'essai Polyolefinen - Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 19 October 2018.

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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-10:2018 E
worldwide for CEN national Members.

Contents Page
European 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 . 9
Annex B (normative) Method for the determination of mass per unit area of uncoated
nonwoven polyolefine materials and adhesive coating . 10
Annex C (normative) Method for the determination of seal strength and mode of specimen
failure . 12
Bibliography . 14

European foreword
This document (EN 868-10:2018) 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 June 2019, and conflicting national standards shall be
withdrawn at the latest by June 2019.
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 868-10:2009.
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
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 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.
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 document specifies test methods and values for sealable adhesive coated nonwoven materials of
polyolefines, manufactured from nonwovens complying with EN 868-9 used for 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 ISO 536, Paper and board — Determination of grammage (ISO 536)
ISO 811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test
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 1974, Paper — Determination of tearing resistance — Elmendorf method (ISO 1974)
EN ISO 2758, Paper — Determination of bursting strength (ISO 2758)
EN ISO 11607-1:2017, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen
method
ISO 6588-2, 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
ASTM D2724, Standard Test Methods for Bonded, Fused, and Laminated Apparel Fabrics
ASTM F88/F88M:2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2017 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
4 Requirements
4.1 General
For any material, preformed sterile barrier system or sterile barrier system, the requirements of
EN ISO 11607-1 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 4.3 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 868-10 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-10 shall contain a statement whether EN ISO 11607-1 is
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, 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 Materials
4.2.1 The coated material shall be translucent or opaque and made of continuous filaments of
polyolefines of a high level of purity and shall not release any substances in such quantities as could
constitute a health risk.
NOTE Attention is drawn to EN ISO 10993-1.
4.2.2 The coated material shall not react with, contaminate, transfer to, or adversely affect the
product packed in it, before, during or after sterilization.
4.2.3 Conditioned material for testing shall comply with the test sample conditioning requirements of
EN ISO 11607-1:2017, Clause 4.
4.3 Performance requirements and test methods
4.3.1 No colour shall leach out of the material. Compliance shall be tested by visual examination of a
hot extract prepared in accordance with the method given in ISO 6588-2 modified to test temperature
of (60 ± 5) °C.
4.3.2 The average mass of 1 m of the conditioned material when tested in accordance with
EN ISO 536 shall be within ± 15 % of the nominal value stated by the manufacturer.
4.3.3 The tensile strength of the conditioned material shall be not less than 4,8 kN/m in the machine
direction and not less than 5,0 kN/m in the cross direction when tested in accordance with
EN ISO 1924-2.
4.3.4 The internal tearing resistance of the conditioned material shall be not less than 1 000 mN in
both machine and cross directions when tested in accordance with EN ISO 1974.
4.3.5 If the nature
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