SIST EN 868-7:2009

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

This part of EN 868 provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868 6, 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 materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization.
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 4.3 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 this part of EN 868 are intended for single use only.

Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 7: Klebemittelbeschichtetes Papier für die Herstellung von siegelfähigen Verpackungen für medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen - Anforderungen und Prüfverfahren

Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 7: Papier enduit d'adhésif pour la fabrication d'emballages thermoscellables à usage médical pour stérilisation à l'oxyde d'éthylène ou par irradiation - Exigences et méthodes d'essai

La présente Partie de l’EN 868 fournit tant méthodes d'essai que valeurs relatives au papier enduit d’adhésif
de scellage, fabriqué à partir de papier conforme aux exigence de l’EN 868-6, et utilisé comme système de
barrière stérile et/ou comme système d'emballage thermoscellable destiné à maintenir l'état de stérilité des
dispositifs médicaux, stérilisés au stade terminal, jusqu'à leur utilisation. Les matériaux décrits dans la
présente partie sont destinés à un usage pour la stérilisation à l’oxyde d’éthylène ou par irradiation.
NOTE 1 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 des 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 dans les paragraphes 4.2 à 4.3 peuvent être utilisées pour
démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de l’EN ISO 11607-1.
NOTE 2 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.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.

Embalaža za končno sterilizirane medicinske pripomočke - 7. del: Papir, oplemeniten z lepilom, za izdelavo embalažnih enot pri toplotnem lepljenju za uporabo v medicini pri sterilizaciji z etilenoksidom ali obsevanjem - 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 868-7:2009 - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

Relations

• Replaced By: SIST EN 868-7:2017 - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
• Effective Date: 01-Apr-2017
• Replaced By: SIST EN 868-7:2017 - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 868-7:2000 - Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
• Effective Date: 01-Oct-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 868-7:2009
01-oktober-2009
1DGRPHãþD
SIST EN 868-7:2000
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3DSLU
RSOHPHQLWHQ]OHSLORP]DL]GHODYRHPEDODåQLKHQRWSULWRSORWQHPOHSOMHQMX]D
XSRUDERYPHGLFLQLSULVWHULOL]DFLML]HWLOHQRNVLGRPDOLREVHYDQMHP=DKWHYHLQ
SUHVNXVQHPHWRGH
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for
low temperature sterilization processes - Requirements and test methods
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte -
Teil 7: Klebemittelbeschichtetes Papier für die Herstellung von siegelfähigen
Verpackungen für medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen -
Anforderungen und Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 7: Papier enduit d'adhésif pour la fabrication d'emballages
thermoscellables à usage médical pour stérilisation à l'oxyde d'éthylène ou par irradiation
- Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-7:2009
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN 868-7:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 868-7:2009

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SIST EN 868-7:2009
EUROPEAN STANDARD
EN 868-7
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-7:1999
English Version
Packaging for terminally sterilized medical devices - Part 7:
Adhesive coated paper for low temperature sterilization
processes - Requirements and test methods
Matériaux d'emballage pour les dispositifs médicaux Verpackungen für in der Endverpackung zu sterilisierende
stérilisés au stade terminal - Partie 7: Papier enduit Medizinprodukte - Teil 7: Klebemittelbeschichtetes Papier
d'adhésif pour la fabrication d'emballages thermoscellables für Niedertemperatur-Sterilisationsverfahren -
à usage médical pour stérilisation à l'oxyde d'éthylène ou Anforderungen und Prüfverfahren
par irradiation - Exigences et méthodes d'essai
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 868-7:2009: E
worldwide for CEN national Members.

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SIST EN 868-7:2009
EN 868-7:2009 (E)
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 .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 fluorescence . 10
Annex C (normative) Method for the determination of water repellency . 11
Annex D (normative) Method for the determination of pore size . 12
Annex E (normative) Method for the determination of regularity of seal adhesive coatings on
paper . 17
Annex F (normative) Method for the determination of mass per unit area of uncoated paper and
adhesive coating . 18
Annex G (normative) Method for the determination of seal strength and visual inspection of the
adhesive coating . 20
Bibliography . 22

2

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SIST EN 868-7:2009
EN 868-7:2009 (E)
Foreword
This document (EN 868-7:2009) 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 868-7:1999.
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 868-7:2009
EN 868-7:2009 (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 EN 868 series.
4

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SIST EN 868-7:2009
EN 868-7:2009 (E)
1 Scope
This part of EN 868 provides test methods and values for sealable adhesive coated paper manufactured from
paper complying with EN 868-6, 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 materials specified in this
part are intended to be used for ethylene oxide or irradiation sterilization.
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 4.3 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 this part of EN 868 are intended for single use only.
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 21974, Paper — Determination of tearing resistance (Elmendorf method) (ISO 1974:1990)
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)
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
5

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SIST EN 868-7:2009
EN 868-7:2009 (E)
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 pulps — Determination of water-soluble sulfates
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply.
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 Materials
The adhesive coating shall not react with, contaminate, transfer to or adversely affect the product packed in it,
before, during or after sterilization.
4.3 Performance requirements and test methods
4.3.1 When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is
not necessary for it to have wet strength properties or any permeability to air, so 4.3.11 and 4.3.16 need not
apply.
4.3.2 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.
4.3.3 The average mass of 1 m² of the conditioned coated paper when tested in accordance with
EN ISO 536 shall be within ± 7,5 % of the nominal value stated by the manufacturer.
4.3.4 The pH of an aqueous extract of the coated paper shall be not less than 5 nor greater than 8 when
tested in accordance with ISO 6588-2.
4.3.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when
tested in accordance with ISO 9197 using an hot extract prepared in accordance with ISO 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.3.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when
tested in accordance with ISO 9198, using an hot extract prepared in accordance with ISO 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.3.7 The uncoated paper 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 m²when tested in accordance with Annex B.
4.3.8 The internal tearing resistance of the conditioned paper shall be not less than 300 mN in both
machine and cross directions when tested in accordance with EN 21974.
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SIST EN 868-7:2009
EN 868-7:2009 (E)
4.3.9 The air permeance of the conditioned coated paper shall be not less than 0,2 µm/Pa ⋅ s and not more
than 6,0 µm/Pa ⋅ s when tested in accordance with ISO 5636-3.
4.3.10 The bursting strength of the conditioned paper shall be not less than 200 kPa when tested in
accordance with EN ISO 2758.
4.3.11 The wet bursting strength of the paper shall be not less than 35 kPa when tested in accordance with
ISO 3689 using an immersion time of 10 min.
4.3.12 The water repellency of the paper shall be such that the penetration time is not less than 20 s when
tested in accordance with Annex C.
4.3.13 When tested in accordance with Annex D, the average of the pore diameters of the ten test coated
pieces shall be lower than or equal to 20 µm. No value shall be greater than 30 µm.
4.3.14 The coating shall be continuous and regular with no uncoated areas or discontinuity in the coating
pattern which could provide gaps or channels in a seal when tested and examined in accordance with
Annex E.
4.3.15 The tensile strength of the conditioned paper shall be not less than 4,0 kN/m in machine direction and
not less than 2,0 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
4.3.16 The wet tensile strength of the paper shall be not less than 0,80 kN/m in machine direction and not
less than 0,40 kN/m in cross direction when tested in accordance with ISO 3781.
4.3.17 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 method).
4.3.18 The mass per unit area of seal adhesive coating shall be within ± 2 g/m² of that stated by the
manufacturer when tested in accordance with Annex F.
4.3.19 The seal strength of the coated paper shall be greater than 0,08 kN/m (1,20 N/15 mm) but not so
strong as to cause fibre tear when tested in accordance with Annex G.
Report whether the tail was supported or unsupported, see G.5.
4.4 Marking of protective packaging
The protective packaging shall be legibly and durably marked with the following information:
a) reference, stock or catalogue number;
b) quantity;
c) the manufacturer's or supplier's name or trade name, and address;
d) date of manufacture in accordance with ISO 8601;
1
e) lot number ;
f) nominal sheet size in millimetres or nominal width of rolls in millimetres and length in metres;
g) the recommended storage conditions;

1 A reference number in order to trace the manufacturing history of the product.
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SIST EN 868-7:2009
EN 868-7:2009 (E)
h) nominal mass in grams per square metre.
5 Information to be supplied by the manufacturer
The manufacturer shall supply instructions for recommended sealing and/or closure conditions and for the
monitoring of critical parameters of seal and/or closure integrity.
NOTE 1 For validation of closure and sealing conditions, see EN ISO 11607-2.
NOTE 2 For heat seals these parameters include the range of temperature, pressure and time.
NOTE 3 For requirements on information to be provided by the manufacturer national or regional legislation can apply,
see in particular Directive 93/42/EEC, Annex I, Section 13.
8

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SIST EN 868-7:2009
EN 868-7:2009 (E)
Annex A
(informative)

Details of significant technical changes between this European Standard
and the previous edition
Changes between this European Standard and EN 868-7:1999 are the following:
a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by:
1) amending the main element of the title, the scope and the terminology;
2) using EN ISO 11607-1 as normative reference regarding the general requirements for materials,
sterile barrier systems and packaging systems;
3) deleting requirements that are covered by EN ISO 11607 (such as requirements on raw materials,
conditioning, quality of the material with regard to tears, creases, localised thickening, leaching of
toxic substances);
b) the specific element of the title of this European Standard has been amended to indicate that the material
covered by this European Standard can be applied to low temperature sterilization processes;
c) in addition to a) first dash, the scope has been modified to:
1) explain that other requirements might be of relevance for additional materials being used inside a
sterile barrier system;
2) clarify that the materials covered by this European Standard are intended for single use only;
d) an explanatory note has been inserted to refer the user of this European Standard to the general
requirements on conditions during production and ha
...