EN 868-2:2009

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

This part of EN 868 provides test methods and values for materials for 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 can be used to demonstrate compliance with one or more but not
all of the requirements of EN ISO 11607-1.
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.
The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials
specified in 4.2.2.4 are intended for reuse.
NOTE 3 If the intended purpose according to the manufacturer of the material for sterile barrier system specifies the
use as sterile field, then the additional requirements of the EN 13795 series apply.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Sterilisierverpackung - Anforderungen und Prüfverfahren

Dieser Teil von EN 868 enthält Prüfverfahren und Werte für Materialien, die 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 können verwendet werden, um Übereinstimmung mit einer oder
mehreren Anforderungen — aber nicht mit allen Anforderungen — der EN ISO 11607-1 nachzuweisen.
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.
Die nach 4.2.2.1 bis 4.2.2.3 dieses Teils von EN 868 festgelegten Materialien sind für den einmaligen
Gebrauch vorgesehen, die nach 4.2.2.4 festgelegten Materialien sind für die Wiederverwendung vorgesehen.
ANMERKUNG 3 Wenn der Hersteller des Materials für das sterile Barrieresystem als vorgesehenen Gebrauch die
Verwendung als steriles Feld festlegt, dann gelten die zusätzlichen Anforderungen der Normenreihe EN 13795.

Matériaux et systémes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 2: Enveloppe de stérilisation – Exigences et méthodes d’essai

Cette Partie de l’EN 868 présente des méthodes d'essai et des valeurs pour les matériaux pour des systèmes de barrière stérile préformés et des systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'à leur utilisation.
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 le paragraphe 4.2 peuvent être utilisées telles quelles pour démontrer la conformité à une ou plusieurs, mais pas à toutes les exigences de l’EN ISO 11607-1.
NOTE 1   Si l’utilisation prévue telle qu’elle est spécifiée par le fabricant comprend la possibilité que le matériau soit utilisé en tant que champ stérile ou drap chirurgical, la série EN 13795 s’applique.
NOTE 2   Si l’utilisation prévue telle qu’elle est spécifiée par le fabricant comprend la possibilité que le matériau soit utilisé en tant que filtre de récipient ou enveloppe interne pour des récipients, des exigences supplémentaires et/ou autres peuvent s’appliquer, voir par exemple, l’EN 868-8.

Embalaža za končno sterilizirane medicinske pripomočke - 2. del. Sterilizacijski embalažni materiali za zavijanje - Zahteve in preskusne metode

General Information

• Status: Withdrawn
• Publication Date: 19-May-2009
• Withdrawal Date: 13-Apr-2025
• 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
• Start Date: 08-Feb-2017
• Completion Date: 14-Apr-2025
• 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 868-2:2009 - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

Relations

• Replaces: EN 868-2:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods
• Effective Date: 22-Dec-2008
• Replaced By: EN 868-2:2017 - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
• Effective Date: 15-Feb-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2009
1DGRPHãþD
SIST EN 868-2:2000
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO6WHULOL]DFLMVNL
HPEDODåQLPDWHULDOL]D]DYLMDQMH=DKWHYHLQSUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap -
Requirements and test methods
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte -
Teil 2: Sterilisierverpackung - Anforderungen und Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 2: Enveloppe de stérilisation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-2:2009
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 868-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-2:1999
English Version
Packaging for terminally sterilized medical devices - Part 2:
Sterilization wrap - Requirements and test methods
Matériaux d'emballage pour les dispositifs médicaux Verpackungen für in der Endverpackung zu sterilisierende
stérilisés au stade terminal - Partie 2: Enveloppe de Medizinprodukte - Teil 2: Sterilisierverpackung -
stérilisation - Exigences et méthodes d'essai 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 868-2:2009: 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 .9
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 fluorescence . 12
Annex C (informative) Method for the determination of drape . 13
Annex D (normative) Method for the determination of water repellency . 14
Annex E (normative) Method for the determination of pore size . 15
Bibliography . 20

Foreword
This document (EN 868-2:2009) 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 868-2:1999.
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 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 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 EN 868 series.
1 Scope
This part of EN 868 provides test methods and values for materials for 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 can be used to demonstrate compliance with one or more but not
all of the requirements of EN ISO 11607-1.
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.
The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials
specified in 4.2.2.4 are intended for reuse.
NOTE 3 If the intended purpose according to the manufacturer of the material for sterile barrier system specifies the
use as sterile field, then the additional requirements of the EN 13795 series 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 20187, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for
monitoring the atmosphere and conditioning of samples (ISO 187:1990)
EN 20535, Paper and board — Determination of water absorptiveness — Cobb method (ISO 535:1991)
EN 20811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test
EN 21974, Paper — Determination of tearing resistance (Elmendorf method) (ISO 1974:1990)
EN 29073-3, Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and
elongation
EN ISO 536, Paper and board — Determination of grammage (ISO 536:1995)
EN ISO 1924-2, Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation
method (ISO 1924-2:1994)
EN ISO 2758, Paper — Determination of bursting strength (ISO 2758:2001)
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)
EN ISO 13937-1, Textiles — Tear properties of fabrics — Part 1: Determination of tear force using ballistic
pendulum method (Elmendorf) (ISO 13937-1:2000)
EN ISO 13938-1, Textiles — Bursting properties of fabrics — Part 1: Hydraulic method for determination of
bursting strength and bursting distension (ISO 13938-1:1999)
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 6588-2:2005, 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
ISO 9237, Textiles — Determination of the permeability of fabrics to air
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
sterile field
area created by sterile drape material where aseptic technique is practised
NOTE A sterile field can be practised e.g. on a back table.
3.2
surgical drape
drape covering a patient or equipment to prevent transfer of infective agents

[see also EN 13795–1:2002]
4 Requirements
4.1 General
The requirements of EN ISO 11607–1 apply.
NOTE 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).
4.2 Performance requirements and test methods
4.2.1 General
4.2.1.1 No colour shall leach out of the wrap. Compliance shall be tested by visual examination of a hot
aqueous extract prepared in accordance with the method given in ISO 6588–2.
4.2.1.2 The average mass of 1 m² of the conditioned wrap when tested in accordance with EN ISO 536
shall be within ± 5 % of the nominal value stated by the manufacturer.
4.2.1.3 The pH of an aqueous extract of the wraps shall be not less than 5 nor greater than 8 when
tested in accordance with ISO 6588-2, hot extraction method.
4.2.1.4 The chloride content of the wrap, 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 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.2.1.5 The sulphate content of the wrap, 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 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.2.1.6 When tested in accordance with Annex B the wrap shall neither exhibit an increase in brightness
due to the optical brightener of more than 1 % nor have more than five fluorescent spots, each having an axis
greater than 1 mm per 0,01 m².
4.2.1.7 The manufacturer shall provide drapeability results and associated test method on request.
NOTE For test method, see e.g EN ISO 9073–9 and Annex C (informative).
4.2.2 Specific requirements
4.2.2.1 Plain paper
4.2.2.1.1 The internal tearing resistance of the conditioned wrap shall be not less than 500 mN in both
machine and cross direction when tested in accordance with EN 21974.
4.2.2.1.2 The air permeance of the conditioned wrap shall be not less than 1,7 µm/Pa ⋅ s at an air pressure
of 1,47 kPa when tested in accordance with ISO 5636-3.
4.2.2.1.3 The bursting strength of the conditioned wrap shall be not less than 110 kPa when tested in
accordance with EN ISO 2758.
4.2.2.1.4 The wet bursting strength of the wrap shall be not less than 35 kPa when tested in accordance
with ISO 3689 using an immersion time of 10 min.
4.2.2.1.5 The water repellency of the wrap shall be such that the penetration time is not less than 20 s
when tested in accordance with Annex D.
4.2.2.1.6 When tested in accordance with Annex E, the average of the pore diameters of the ten test
pieces shall be lower than or equal to 35 µm. No value shall be greater than 50 µm.
4.2.2.1.7 The tensile strength of the conditioned wrap shall be not less than 1,33 kN/m in machine direction
and not less than 0,67 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
4.2.2.1.8 The wet tensile strength of the wrap shall be not less than 0,33 kN/m in machine direction and not
less than 0,27 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.2.1.9 The surface absorbency of each side of the paper shall be not more than 20 g/m² when tested in
accordance with EN 20535 using a 60 s exposure time (Cobb test).
4.2.2.2 Creped Paper
4.2.2.2.1 The wrap shall be creped to give increased flexibility.
4.2.2.2.2 The elongation at break of the conditioned wrap shall be not less than 10 % in the machine
direction and not less than 2 % in the cross direction when tested by measurement of the elongation in
conjunction with the test for tensile strength in accordance with EN ISO 1924-2.
4.2.2.2.3 The water repellency of the wrap shall be such that the penetration time is not less than 20 s
when tested in accordance with Annex D.
4.2.2.2.4 When tested in accordance with Annex E, the average of the pore diameters of the ten test
pieces shall be lower than or equal to 35 µm. No value shall be greater than 50 µm.
4.2.2.2.5 The tensile strength of the conditioned wrap shall be not less than 1,33 kN/m in machine direction
and not less than 0,67 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
4.2.2.2.6 The wet tensile strength of the wrap shall be not less than 0,33 kN/m in machine direction and not
less than 0,27 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.2.3 Nonwoven wrapping material
NOTE For the purpose of this specification, a nonwoven for sterile barrier systems can be described as a bonded
web made of textile and/or non-textile fibres.
4.2.2.3.1 The internal tearing resistance of the conditioned nonwoven wrap shall be not less than 750 mN
in the machine direction and 1 000 mN in the cross direction when tested in accordance with EN 21974.
4.2.2.3.2 The bursting strength of the conditioned nonwoven wrap shall be not less than 130 kPa when
tested in accordance with EN ISO 2758.
4.2.2.3.3 The wet bursting strength of the nonwoven wrap shall be not less than 90 kPa when tested in
accordance with ISO 3689 using an immersion time of 10 min.
4.2.2.3.4 The elongation at break of the conditioned nonwoven wrap shall be not less than 5 % in the
machine direction and not less than 7 % in the cross direction when tested in accordance with EN ISO 1924-2.
4.2.2.3.5 The resistance to water penetration of the nonwoven wrap shall be determined using the
hydrostatic head test based on EN 20811. This test method is currently under revision and considering other
test conditions (use of support screen with an open area greater than 50 % in order to avoid early fabric
rupture). Minimum requirements will be set as soon as the revised test method is available. Manufacturers
may report test results.
4.2.2.3.6 The tensile strength of the conditioned nonwoven wrap shall be not less than 1,00 kN/m in
machine direction and not less than 0,65 kN/m in cross direction when tested in accordance with
EN ISO 1924-2.
4.2.2.3.7 The wet tensile strength of the nonwoven wrap shall be not less than 0,75 kN/m in machine
direction and not less than 0,50 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.2.4 Woven textile material
4.2.2.4.1 When the woven textile material is to be used to manufacture packaging intended to be irradiation
sterilized only, it is not necessary for it to be permeable to air, so 4.2.2.4.6 need not to apply.
4.2.2.4.2 Requirements for the processing of reusable fabrics as given in EN ISO 11607-1:2006, 5.1.11
and 5.1.12 apply and should include the means to quantify and control the number of processing cycles.
4.2.2.4.3 The tensile strength, dry and wet, of the wrap shall be not less than 300 N in the warp and weft
directions when tested in accordance with strip method of EN 29073-3.
4.2.2.4.4 The tear strength, dry and wet, of the wrap shall be not less than 6 N in the warp and weft
directions when tested in accordance with EN ISO 13937-1. The samples for the "wet" test shall be prepared
according to EN 29073-3.
4.2.2.4.5 The bursting strength “dry” and “wet” of the wraps shall not be less than 100 kPa when tested in
accordance with EN ISO 13938-1. The preparation of samples for wet state testing shall be performed
according to EN 29073-3.
4.2.2.4.6 The air permeability of the wrap shal
...