EN 868-3:2017

SLOVENSKI STANDARD
01-april-2017
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SIST EN 868-3:2009
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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
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3:
Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung
von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und
Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 3 : Papier utilisé dans la fabrication des sacs en papier (spécifiés dans
l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5) -
Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-3:2017
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 868-3
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-3:2009
English Version
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
Emballages des dispositifs médicaux stérilisés au stade Verpackungsmaterialien für in der Endverpackung zu
terminal - Partie 3: Papier utilisé dans la fabrication sterilisierende Medizinprodukte - Teil 3: Papier zur
des sacs en papier (spécifiés dans l'EN 868-4) et dans Herstellung von Papierbeuteln (festgelegt in EN 868-4)
la fabrication de sachets et gaines (spécifiés dans l'EN und zur Herstellung von Klarsichtbeuteln und -
868-5) - Exigences et méthodes d'essai schläuchen (festgelegt in EN 868-5) - 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 868-3:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Requirements . 6
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 water repellency . 10
B.1 Apparatus . 10
B.2 Reagent . 10
B.3 Procedure. 10
B.4 Repeatability and reproducibility. 11
B.5 Test report . 11
Annex C (normative) Method for the determination of pore size . 12
C.1 Principle . 12
C.2 Test liquid . 12
C.3 Apparatus . 12
C.4 Preparation of test specimens . 14
C.5 Procedure. 14
C.6 Result . 15
C.6.1 Calculation and expression of results . 15
C.6.2 Derivation of formula for calculation of equivalent pore radius . 15
C.7 Repeatability and reproducibility. 16
C.8 Test report . 16
Annex D (informative) Repeatability and reproducibility of test methods . 17
Bibliography . 19

European foreword
This document (EN 868-3:2017) 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 868-3:2009.
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 European Standard specifies test methods and values for paper, used in the manufacture of paper
bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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 20187, Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for
monitoring the atmosphere and conditioning of samples (ISO 187)
EN ISO 535, Paper and board - Determination of water absorptiveness - Cobb method (ISO 535)
EN ISO 536, Paper and board - Determination of grammage (ISO 536)
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 11607-1:2009+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)
ISO 2470-2, Paper, board and pulps — Measurement of diffuse blue reflectance factor — Part 2: Outdoor
daylight conditions (D65 brightness)
ISO 3689, Paper and board — Determination of bursting strength after immersion in water
ISO 3781, Paper and board — Determination of tensile strength after immersion in water
ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen
method
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 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 4.2 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 868–3 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-3 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, 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 Performance requirements and test methods
NOTE See Annex D for repeatability and reproducibility of the test methods: pore diameters, sulphate
content, chloride content and water repellency. For information on statement of precision and/or bias,
repeatability and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1.
4.2.1 The requirements of 4.2.11 and 4.2.15 do not apply to materials solely used in irradiation
sterilization packaging.
4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot
aqueous extract prepared in accordance with the method given in ISO 6588-2.
4.2.3 The average mass of 1 m of the conditioned paper when tested in accordance with EN ISO 536
shall be within ± 5 % of the nominal value stated by the manufacturer.
4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 or greater than 8 when tested
in accordance with ISO 6588-2, hot extraction method.
4.2.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when
tested in accordance with ISO 9197 using a hot extract prepared in accordance with ISO 6588-2:2012,
7.2 except that 2 ml of potassium chloride solution is not added.
4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when
tested in accordance with ISO 9198, using a hot extract prepared in accordance with ISO 6588-2:2012,
7.2 except that 2 ml of potassium chloride solution is not added.
4.2.7 When tested in accordance with ISO 2470-2 the material shall not exhibit an increase in D65
brightness, due to the optical brightener agents, of more than 1 %; calculated as the ratio of the D65
brightness measured with the 420 nm UV-cut-off filter in place to the D65 brightness measured without
420 nm UV-cut-off filter.
4.2.8 When exposed at 25 cm from a UV light source, the material shall not have per 0,01 m more than
five fluorescent spots, each having an axi
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