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

This draft European Standard 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.
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.
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 Niedertemperatur-Sterilisationsverfahren - Anforderungen und Prüfverfahren

Dieser europäische Norm-Entwurf enthält Prüfverfahren und Werte für siegelfähiges klebemittelbeschichtetes Papier, hergestellt aus Papier nach EN 868 6, das dazu vorgesehen ist, als Sterilbarrieresystem und/oder Ver-packungssystem die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungs-zeitpunkt zu erhalten. Die in diesem Teil festgelegten Materialien sind für die Sterilisation mit Ethylenoxid oder Strahlen vorgesehen.
Die Erfordernis für eine Schutzverpackung darf 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, 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.
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.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 7: Papier enduit d’adhésif pour des procédés de stérilisation à basse température - Exigences et méthodes d’essai

Le présent projet de Norme européenne fournit des méthodes d'essai et des valeurs applicables au papier enduit d’adhésif de scellage, fabriqué à partir de papier conforme à l’EN 868 6 et utilisé comme système de barrière stérile et/ou comme système d'emballage 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.
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.
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 sterilizacijske procese z nizko temperaturo - Zahteve in preskusne metode

Ta osnutek evropskega standarda podaja preskusne metode in vrednosti za papir, oplemeniten z lepilom in izdelan iz papirja v skladu s standardom EN 868-6, ki se uporablja kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe. Materiali, določeni v tem delu, so namenjeni uporabi za sterilizacijo z etilenoksidom ali obsevanjem.
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.
Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, filtrirni vsebnik, 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.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.

General Information

Status
Published
Publication Date
07-Feb-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
08-Feb-2017
Completion Date
08-Feb-2017

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SLOVENSKI STANDARD
SIST EN 868-7:2017
01-april-2017
1DGRPHãþD
SIST EN 868-7:2009
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3DSLU

RSOHPHQLWHQ]OHSLORP]DVWHULOL]DFLMVNHSURFHVH]QL]NRWHPSHUDWXUR=DKWHYHLQ

SUHVNXVQHPHWRGH

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for

low temperature sterilization processes - Requirements and test methods

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 7:

Klebemittelbeschichtetes Papier für Niedertemperatur-Sterilisationsverfahren -
Anforderungen und Prüfverfahren

Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade

terminal - Partie 7 : Papier enduit d'adhésif à destination des procédés de stérilisation à

basses températures - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-7:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.040 0DWHULDOLLQSULSRPRþNL]D Packaging materials and
SDNLUDQMH accessories
SIST EN 868-7:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 868-7:2017
---------------------- Page: 2 ----------------------
SIST EN 868-7:2017
EN 868-7
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-7:2009
English Version
Packaging for terminally sterilized medical devices - Part
7: Adhesive coated paper for low temperature sterilization
processes - Requirements and test methods

Emballages des dispositifs médicaux stérilisés au stade Verpackungsmaterialien für in der Endverpackung zu

terminal - Partie 7: Papier enduit d'adhésif pour des sterilisierende Medizinprodukte - Teil 7:

procédés de stérilisation à basse température - Klebemittelbeschichtetes Papier für

Exigences et méthodes d'essai Niedertemperatur-Sterilisationsverfahren -
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 868-7:2017 E

worldwide for CEN national Members.
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SIST EN 868-7:2017
EN 868-7:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 7

4 Requirements ................................................................................................................................................... 7

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 water repellency ............................................. 11

B.1 Apparatus ........................................................................................................................................................ 11

B.2 Reagent ............................................................................................................................................................ 11

B.3 Procedure........................................................................................................................................................ 11

B.4 Repeatability and reproducibility.......................................................................................................... 11

B.5 Test report ...................................................................................................................................................... 12

Annex C (normative) Method for the determination of pore size ............................................................. 13

C.1 Principle .......................................................................................................................................................... 13

C.2 Test liquid ....................................................................................................................................................... 13

C.3 Apparatus ........................................................................................................................................................ 13

C.4 Preparation of test specimens ................................................................................................................. 15

C.5 Procedure........................................................................................................................................................ 15

C.6 Result ................................................................................................................................................................ 16

C.6.1 Calculation and expression of results ................................................................................................... 16

C.6.2 Derivation of formula for calculation of equivalent pore radius ................................................ 16

C.7 Repeatability and reproducibility.......................................................................................................... 17

C.8 Test report ...................................................................................................................................................... 17

Annex D (normative) Method for the determination of regularity of seal adhesive coatings

on paper ........................................................................................................................................................... 18

D.1 Principle of the method ............................................................................................................................. 18

D.2 Apparatus ........................................................................................................................................................ 18

D.3 Procedure........................................................................................................................................................ 18

D.4 Test report ...................................................................................................................................................... 18

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SIST EN 868-7:2017
EN 868-7:2017(E)

Annex E (normative) Method for the determination of mass per unit area of uncoated paper

and adhesive coating ................................................................................................................................... 19

E.1 Units ................................................................................................................................................................... 19

E.2 Principle of the method .............................................................................................................................. 19

E.3 Apparatus ........................................................................................................................................................ 19

E.4 Procedure ........................................................................................................................................................ 19

E.5 Results .............................................................................................................................................................. 20

E.6 Test report ...................................................................................................................................................... 20

Annex F (normative) Method for the determination of seal strength and mode of specimen

failure ................................................................................................................................................................ 21

F.1 Principle of the method .............................................................................................................................. 21

F.2 Test method .................................................................................................................................................... 21

F.3 Preparation of test-specimen ................................................................................................................... 21

F.4 Procedure ........................................................................................................................................................ 21

F.5 Test report ...................................................................................................................................................... 22

Annex G (informative) Repeatability and reproducibility of test methods ............................................ 23

Bibliography ................................................................................................................................................................. 25

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SIST EN 868-7:2017
EN 868-7:2017 (E)
European foreword

This document (EN 868-7:2017) 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 868-7:2009.

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.
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SIST EN 868-7:2017
EN 868-7:2017(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.

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.

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SIST EN 868-7:2017
EN 868-7:2017 (E)
1 Scope

This European Standard specifies 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.

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
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SIST EN 868-7:2017
EN 868-7:2017(E)
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 4.3 can be used to demonstrate compliance with one or more

but not all of the requirements of EN ISO 11607-1.

NOTE 1 Compliance to EN 868–7 does not automatically mean compliance to EN ISO 11607-1.

A confirmation of compliance to EN 868-7 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 1 See Annex G 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.

NOTE 2 Test methods included in Annex D “regularity of seal adhesive coatings on paper”, Annex E

“Determination of mass per unit area of uncoated paper and adhesive coating” and Annex F “Determination of seal

strength and visual inspection of adhesive coating” have no statement of precision and bias or repeatability and

reproducibility, yet.

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 4.2.12 and

4.2.17 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 m 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.

4.2.4 The pH of an aqueous extract of the coated paper shall be not less than 5 or greater than 8 when

tested in accordance with ISO 6588-2, hot extraction method.
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SIST EN 868-7:2017
EN 868-7:2017 (E)

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 an 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 an 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 axis greater than 1 mm.
NOTE The UV light to be used is the one described as per Annex B.

4.2.9 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 ISO 1974.

4.2.10 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.

4.2.11 The bursting strength of the conditioned paper shall be not less than 200 kPa when tested in

accordance with EN ISO 2758.

4.2.12 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.

4.2.13 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 B.

4.2.14 When tested in accordance with Annex C, 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.

4.2.15 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 D.

4.2.16 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.

4.2.17 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.

4.2.18 The surface absorbency of each side of the paper shall be not more than 20 g/m when tested in

accordance with EN ISO 535 using a 60 s exposure time (Cobb method).

4.2.19 The mass per unit area of seal adhesive coating shall be within ± 2 g/m of that stated by the

manufacturer when tested in accordance with Annex E.

4.2.20 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 F.
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SIST EN 868-7:2017
EN 868-7:2017(E)
Report whether the tail was supported or unsupported, see F.5.
4.3 Marking of transport packaging

The transport packaging shall be legibly and durably marked with the following information:

a) reference, stock or catalogue number;
b) quantity;
c) the name or trade name and address of the manufacturer;
d) date of manufacture in accordance with ISO 8601;
e) lot number ;

f) nominal sheet size or nominal width of rolls in millimetres and length in metres;

g) the recommended storage conditions;
h) nominal mass in grams per square metre;
i) intended for single use only.
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.

A reference number in order to trace the manufacturing history of the product.
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SIST EN 868-7:2017
EN 868-7:2017 (E)
Annex A
(informative)
Details of significant technical changes between this European Standard
and the previous edition
Changes between this European Standard and EN 868-7:2009 are the following:

a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by:

1) elucidating the requirements given by EN ISO 11607-1 as general requirements for this

standard;

2) formulating the significance and limits of the requirements of this standard with respect to the

requirements given by EN ISO 11607-1;

3) linking the test methods with regard to information on statement of precision and bias,

repeatability and reproducibility to EN ISO 11607-1:2009+A1:2014, Table B.1;

b) the test method on fluorescence is in accordance with ISO 2470-2. The test method according

Annex B has been deleted;

c) the test method for determination of seal strength and mode of specimen failure as per Annex F has

been amended;

d) updating of the following test methods by a statement of repeatability and reproducibility:

1) method for the determination of water repellency as per Annex B;
2) method for the determination of pore size as per Annex C;

e) providing of informative data for repeatability and reproducibility of the following test methods as

per Annex D:
1) method for the determination of water repellency as per Annex B;
2) method for the determination of pore size as per Annex C;
3) chloride content;
4) sulphate content;
f) updating of the bibliography.
NOTE This list is not exhaustive.
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SIST EN 868-7:2017
EN 868-7:2017(E)
Annex B
(normative)
Method for the determination of water repellency
B.1 Apparatus

B.1.1 An ultraviolet light source and light meter with a range of wavelength of 315 nm to 380 nm.

B.1.2 Flat dish, approximately 200 mm x 150 mm x 15 mm.
B.1.3 Desiccator.
B.1.4 Stopwatch.

B.1.5 Powder dispenser, with a sieve of nominal aperture size between 0,125 mm and 0,150 mm at

one end and closed at the other.
B.2 Reagent
Dry indicator powder prepared as described below.

Grind 20 g of sucrose in a mortar and pass through a sieve of nominal aperture size 0,063 mm to

0,075 mm. Dry the sieved sucrose in a desiccator over silica gel or in an oven at 105 °C to 110 °C. Mix

10 g of the dry sucrose with 10 mg of sodium fluorescein and pass the mixture 5 times through a sieve

of nominal aperture size 0,063 mm to 0,075 mm and finally transfer the dry indicator powder to the

powder dispenser.

The dry indicator powder in the powder dispenser should be stored either in a desiccator or in an oven

at 105 °C to 110 °C.
B.3 Procedure

Take 10 test pieces of conditioned paper, each of size 60 mm x 60 mm. Separate the samples into two

groups of five, one group with the 'wire-side' uppermost and the other with the 'top-side' uppermost.

For each sample make two folds, each 10 mm high at right angles along two edges. Fill the flat dish with

purified water at the conditioning temperature to a depth of 10 mm. Switch on the UV lamp and allow it

to develop full output and adjust the distance of the lamp so that the irradiance at the level of the water

in the dish is (300 ± 20) µW/cm . Sprinkle the upper surface of a test piece thinly with indicator powder

from the dispenser. Float the test piece on the water under the UV light source and note the time taken

for a general fluorescence to appear. Repeat the procedure with the remaining nine test pieces.

The water repellency of the paper is considerably influenced by the temperature of the water which

shall be maintained within the specified limits (23 ± 1) °C.
B.4 Repeatability and reproducibility
See Annex G for repeatability and reproducibility of the test method.
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SIST EN 868-7:2017
EN 868-7:2017 (E)
B.5 Test report
The test report shall include the following information:
a) the mean penetration time in seconds for each side of the paper;

b) on request, the identification of the product under test, the identification of the test-house and the

date;
c) the normative reference of the test method.
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