SIST EN 868-7:2017

SLOVENSKI STANDARD
oSIST prEN 868-7:2015
01-oktober-2015
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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: prEN 868-7
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN 868-7:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 868-7:2015

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oSIST prEN 868-7:2015

EUROPEAN STANDARD
DRAFT
prEN 868-7
NORME EUROPÉENNE

EUROPÄISCHE NORM

August 2015
ICS 11.080.30 Will supersede 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
 Verpackungen für in der Endverpackung zu sterilisierende
Medizinprodukte - Teil 7: Klebemittelbeschichtetes 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 868-7:2015 E
worldwide for CEN national Members.

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Contents Page
Foreword .4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .7
4 Requirements .7
4.1 General .7
4.2 Materials .7
4.3 Performance requirements and test methods .7
4.4 Marking of protective packaging.9
5 Information to be supplied by the manufacturer .9
Annex A (informative) Details of significant technical changes between this draft 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 . 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 (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
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
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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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Foreword
This document (prEN 868-7:2015) 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 868-7:2009.
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 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.
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)
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
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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
ASTM F88/F88M, Standard Test Method for Seal Strength of Flexible Barrier Materials
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. Statements on compliance with prEN 868-7 shall include a statement on compliance
with EN ISO 11607-1.
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 Compliance to prEN 868–7 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to prEN 868-7 shall contain a statement whether EN ISO 11607-1 is covered.
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
NOTE 1 See Annex G 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.
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.
4.3.1 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.
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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.
2
of the conditioned coated paper when tested in accordance with
4.3.3 The average mass of 1 m
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 sulfate content of the paper, calculated as sodium sulfate, 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
4.3.7.1 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.
2
more
4.3.7.2 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.
4.3.8 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.
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 B.
4.3.13 When tested in accordance with Annex C, the average of the pore diameters of the 10 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 D.
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.
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4.3.17 The surface absorbency of each side of the paper shall be not more than 20 g/m when tested in
accordance with EN 20535 using a 60 s exposure time (Cobb method).
2
of that stated by the
4.3.18 The mass per unit area of seal adhesive coating shall be within ± 2 g/m
manufacturer when tested in accordance with Annex E.
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 F.
Report whether the tail was supported or unsupported, see F.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;
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.

1) A reference number in order to trace the manufacturing history of the product.
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Annex A
(informative)

Details of significant technical changes between this draft European
Standard and the previous edition
Changes between this draft European Standard and EN 868-7:2009 are the following:
a) changes in order to align this draft 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) sulfate content;
f) updating of the Bibliography
NOTE This list is not exhaustive.
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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
2
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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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 number of the standard that has been used for the test.
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Annex C
(normative)

Method
...