SIST EN 868-6:2017

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

This draft European Standard provides test methods and values for paper used in the manufacture of preformed 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 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs.
NOTE 1   The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7.
NOTE 2   Paper according to EN 868-3 can also be used for these sterilization processes.
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 filters, 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 6: Papier für Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prüfverfahren

Dieser europäische Norm-Entwurf enthält Prüfverfahren und Werte für Papier zur Herstellung von vorgefertigten Sterilbarrieresystemen und/oder Verpackungssystemen, die dazu vorgesehen sind, 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 der Normenreihe 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 4.3 können daher verwendet werden, um Übereinstimmung mit einer oder mehreren Anforderung(en) - aber nicht mit allen Anforderungen - der EN ISO 11607-1 nachzuweisen.
Das in diesem Teil von EN 868 festgelegte Papier ist zur anteiligen oder vollständigen Herstellung von Beuteln, Form- und Füllpackungen und Abdeckstoffen für Verpackungen bestimmt.
ANMERKUNG 1   Das in diesem Teil der Normenreihe EN 868 festgelegte Papier ist zur Herstellung von Sterilbarriere¬systemen geeignet, die bei Sterilisationsverfahren mit Ethylenoxid, Strahlen oder Niedertemperatur Dampf Formaldehyd eingesetzt werden, sowie für die Herstellung von beschichtetem Papier nach EN 868 7.
ANMERKUNG 2   Papier nach EN 868 3 kann ebenfalls für diese Sterilisationsverfahren verwendet werden.
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.

Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 6 : Papier à destination des procédés de stérilisation à basses températures - Exigences et méthodes d'essai

Le présent projet de Norme européenne fournit des méthodes d'essai et des valeurs applicables au papier utilisé dans la fabrication de systèmes de barrière stérile préformés et/ou des 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 4.3 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.
Le papier spécifié dans la présente partie de la série EN 868 est destiné à être utilisé dans la fabrication partielle ou complète de pochettes, d'emballages thermoformés et d'opercules pour emballages.
NOTE 1   Le papier spécifié dans la présente partie de la série EN 868 est adapté pour la fabrication de systèmes de barrière stérile destinés à être utilisés dans des processus de stérilisation à l’oxyde d’éthylène ou par irradiation ou par formaldéhyde et vapeur à faible température (LTSF) et pour produire des papiers enduits d’adhésifs conformément à l’EN 868-7.
NOTE 2   Un papier conforme à l’EN 868-3 peut également être utilisé pour ces processus de stérilisation.
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, filtres 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 - 6. del: Papir za sterilizacijske procese z nizko temperaturo - Zahteve in preskusne metode

Ta osnutek evropskega standarda določa preskusne metode in vrednosti za papir za izdelavo za predoblikovanih sterilnih pregradnih sistemov in/ali sistemov 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 4.3 se lahko uporabljajo za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Papir, podan v tem delu skupine standardov EN 868, je namenjen za delno ali celotno izdelavo vrečk, oblike ter polnil in pokrovov za pakete.
OPOMBA 1   Papir, podan v tem delu skupine standardov EN 868, je primeren za izdelavo sterilnih pregradnih sistemov za procese sterilizacije z etilenoksidom, obsevanjem ali paro in formaldehidom pri nizki temperaturi ter izdelavo premazanega papirja v skladu s standardom EN 868-7.
OPOMBA 2   Papir v skladu s standardom EN 868-3 se lahko uporabi tudi za te procese sterilizacije.
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 vsebniki, 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
• Public Enquiry End Date: 29-Oct-2015
• Publication Date: 27-Feb-2017
• ICS: 11.080.30 - Sterilized packaging
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 21-Feb-2017
• Due Date: 28-Apr-2017
• Completion Date: 28-Feb-2017
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 868-6:2017 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods

Relations

• Replaces: SIST EN 868-6:2009 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
• Effective Date: 01-Apr-2017

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6: Papier für Niedertemperatur-Sterilisationsverfahren - Anforderungen und PrüfverfahrenMatériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 6 : Papier à destination des procédés de stérilisation à basses températures - Exigences et méthodes d'essaiPackaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods55.040SDNLUDQMHPackaging materials and accessories11.080.30Sterilizirana embalažaSterilized packagingICS:Ta slovenski standard je istoveten z:EN 868-6:2017SIST EN 868-6:2017en,fr,de01-april-2017SIST EN 868-6:2017SLOVENSKI
STANDARDSIST EN 868-6:20091DGRPHãþD



SIST EN 868-6:2017



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 868-6
February
t r s y ICS
s sä r z rä u r Supersedes EN
z x zæ xã t r r {English Version
Packaging for terminally sterilized medical devices æ Part
xã Paper for low temperature sterilization processes æ Requirements and test methods Emballages des dispositifs médicaux stérilisés au stade terminal æ Partie
xã Papier pour des procédés de stérilisation à basse température æ Exigences et méthodes d 5essai
Verpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte æ Teil
xã Papier für NiedertemperaturæSterilisationsverfahren æ Anforderungen und Prüfverfahren This European Standard was approved by CEN on
v December
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
9
t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
z x zæ xã t r s y ESIST EN 868-6:2017



EN 868-6:2017 (E) 2 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. 10 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
SIST EN 868-6:2017



EN 868-6:2017 (E) 3 European foreword This document (EN 868-6:2017) 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 868-6:2009. 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. SIST EN 868-6:2017



EN 868-6:2017 (E) 4 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. SIST EN 868-6:2017



EN 868-6:2017 (E) 5 1 Scope This European Standard specifies test methods and values for paper used in the manufacture of preformed 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. Paper specified in this European Standard is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for trays. NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868–7. NOTE 2 Paper according to EN 868–3 can also be used for these sterilization processes. 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 SIST EN 868-6:2017



EN 868-6:2017 (E) 6 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 868–6 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-6 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 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 4.2.11, 4.2.12 and 4.2.15 need not apply. 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 m2 of the conditioned paper when tested in accordance with EN ISO 536 shall be within ± 5 % of the nominal value stated by the manufacturer. SIST EN 868-6:2017



EN 868-6:2017 (E) 7 4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 nor 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 so
...

SLOVENSKI STANDARD
oSIST prEN 868-6:2015
01-oktober-2015
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3DSLU]D
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Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature
sterilization processes - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 6:
Papier für Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prüfverfahren
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 6 : Papier à destination des procédés de stérilisation à basses
températures - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-6
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN 868-6:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 868-6:2015

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oSIST prEN 868-6:2015

EUROPEAN STANDARD
DRAFT
prEN 868-6
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2015
ICS 11.080.30 Will supersede EN 868-6:2009
English Version
Packaging for terminally sterilized medical devices - Part 6:
Paper for low temperature sterilization processes -
Requirements and test methods
 Verpackungen für in der Endverpackung zu sterilisierende
Medizinprodukte - Teil 6: Papier für Niedertemperatur-
Sterilisationsverfahren - Anforderungen und Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-6:2015 E
worldwide for CEN national Members.

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oSIST prEN 868-6:2015
prEN 868-6:2015 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Requirements .6
4.1 General .6
4.2 Performance requirements and test methods .6
4.3 Marking of protective packaging.7
5 Information to be supplied by the manufacturer .8
Annex A (informative) Details of significant technical changes between this draft 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 . 10
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 . 13
C.5 Procedure . 13
C.6 Result . 14
C.6.1 Calculation and expression of results . 14
C.6.2 Derivation of formula for calculation of equivalent pore radius . 14
C.7 Repeatability and reproducibility . 15
C.8 Test report . 15
Annex D (informative) Repeatability and reproducibility of test methods . 17
Bibliography . 19

2

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oSIST prEN 868-6:2015
prEN 868-6:2015 (E)
Foreword
This document (prEN 868-6:2015) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the Enquiry.
This document will supersede EN 868-6:2009.
Annex A provides details of significant technical changes between this draft 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).
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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 needs to 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.
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.
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1 Scope
This draft European Standard provides test methods and values for paper used in the manufacture of
preformed 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 4.3 can be used to demonstrate compliance with one or more
but not all of the requirements of EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of
pouches and form and fill packs and lidding material for packs.
NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems
to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce
coated paper according to EN 868–7.
NOTE 2 Paper according to EN 868–3 can also be used for these sterilization processes.
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 filters, 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.
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 187:1990)
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)
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 2758, Paper — Determination of bursting strength (ISO 2758)
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)
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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 6588-2:2005, 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
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
For any material, preformed sterile barrier system or sterile barrier system, the requirements of
EN ISO 11607-1 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 Compliance to prEN 868–6 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to prEN 868-6 shall contain a statement whether EN ISO 11607-1 is covered.
4.2 Performance requirements and test methods
NOTE See Annex D for repeatability and reproducibility of the test methods: pore diameters, sulfate content, chloride
content and water repellency. For information on statement of precision and/or bias, repeatability and reproducibility of
other test methods, see Table B.1 in EN ISO 11607-1:2009/A1:2014.
4.2.1 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 4.2.11, 4.2.12 and 4.2.15
need not apply.
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.
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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 nor 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 6588-2:2005, 7.2
except that 2 ml of potassium chloride solution is not added.
4.2.6 The sulfate content of the paper, calculated as sodium sulfate, 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.
4.2.7
4.2.7.1 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.
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4.2.7.2 When exposed at 25 cm from a UV light source, the material shall not have per 0,01 m
than five fluorescent spots, each having an axis greater than 1 mm.
NOTE The UV light to be used is the one described as per Annex B.
4.2.8 The internal tearing resistance of the conditioned paper shall be not less than 300 mN in both
machine and cross direction when tested in accordance with EN 21974.
4.2.9 The air permeance of the conditioned paper shall be not less than 0,2 µm/Pa ⋅ s at an air pressure of
1,47 kPa when tested in accordance with I
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