EN 868-6:2025

SLOVENSKI STANDARD
01-junij-2025
Nadomešča:
SIST EN 868-6:2017
Embalaža za končno sterilizirane medicinske pripomočke - 6. del: Papir za
sterilizacijske procese z nizko temperaturo - Zahteve in preskusne metode
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 zur Sterilisation mit Sterilisationsverfahren mit niedriger Temperatur -
Anforderungen und Prüfverfahren
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 6 : Papier pour
la fabrication d'emballages à usage médical pour stérilisation par l'oxyde d'éthylène ou
par irradiation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-6:2025
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.040 Materiali in pripomočki za Packaging materials and
pakiranje accessories
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 868-6
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2025
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-6:2017
English Version
Packaging for terminally sterilized medical devices - Part
6: Paper for low temperature sterilization processes -
Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 6 : Papier pour des procédés de sterilisierende Medizinprodukte - Teil 6: Papier für
stérilisation à basse température - Exigences et Niedertemperatur-Sterilisationsverfahren -
méthodes d'essai Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 14 March 2025.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-6:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements . 7
5 Performance requirements and test methods . 7
6 Sterilization compatibility . 8
7 Labelling . 9
7.1 Transport packaging . 9
7.2 Labelling of individual units . 9
8 Environmental declarations . 9
Annex A (normative) Method for the determination of water repellency . 10
Annex B (normative) Method for the determination of pore size . 13
Annex C (informative) Repeatability and reproducibility of test methods . 18
Annex D (informative) Environmental aspects . 20
Bibliography . 23

European foreword
This document (EN 868-6:2025) 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 October 2025, and conflicting national standards shall
be withdrawn at the latest by October 2025.
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 868-6:2017.
a) The scope of the document was amended for clarity and alignment with other parts of EN 868.
b) The document was renumbered to limit the list numbering to 3 levels only for better readability.
c) Clause 4 “General requirements” was slightly revised for clarity and aligned with the other parts of
EN 868 series and a statement was added clarifying when requirements apply.
d) Clause 6 “Sterilization compatibility” was added and aligned with the other parts of EN 868 series.
e) Clause 8 “Environmental declarations” was added, aligned with the other parts of EN 868 series.
f) The list of major changes was moved to the Foreword, thus the Annex with “Details of significant
technical changes between this European Standard and the previous edition” (former Annex A) was
deleted.
g) New Clause “Environmental aspects of testing” was added to each test method in Annexes A and B.
h) New Annex D regarding environmental aspects was added.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United
Kingdom.
Introduction
The EN ISO 11607 series of standards consists of two parts under the general title “Packaging for
terminally sterilized medical devices”. EN ISO 11607-1 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. EN ISO 11607-
2 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 of standards have been developed mainly for materials and sterile barrier systems
used in health care facilities sterilization processes. Materials complying with part 6 of the EN 868 series
can also be used for industrial sterilization. The EN 868 series of standards can be used to demonstrate
compliance with one or more of the requirements specified in EN ISO 11607-1.
Considering CEN Guide 4 [1] and the CEN environmental checklists, this revision has been complemented
with a new annex with guidance to encourage users to also include environmental aspects when applying
the EN 868 series of standards with the objective to minimize the environmental impact. Environmental
aspects have also been included into the description of test methods with the same objective.
1 Scope
This document specifies test methods and values for paper used in the manufacture of single-use
preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by
means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of
EN 868 specifies materials, test methods and values that are specific to the products covered by this
document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 187, 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 11607-1:2020, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 14021, Environmental labels and declarations — Self-declared environmental claims (Type II
environmental labelling) (ISO 14021)
EN ISO 14025, Environmental labels and declarations — Type III environmental declarations — Principles
and procedures (ISO 14025)
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 6588-2:2021, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot
extraction
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
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 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
4 General requirements
4.1 For any material, preformed sterile barrier system or sterile barrier system, the requirements of
EN ISO 11607-1 shall apply.
NOTE 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 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 Clause 5 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.
NOTE 2 This document introduces test methods in Annex A and Annex B. Annex C provides a statement on
repeatability and reproducibility of the test methods for 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 EN ISO 11607-1:2020, Table B.1.
4.3 All requirements in Clause 5 shall be applied for testing materials before sterilization.
4.4 A confirmation of compliance to EN 868-6 shall contain a statement whether EN ISO 11607-1 is
covered.
5 Performance requirements and test methods
5.1 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.
5.2 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.
5.3 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.
5.4 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 6588-2:2021, 7.2
except that 2 ml of potassium chloride solution is not added.
5.5 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 6588-2:2021, 7.2
except that 2 ml of potassium chloride solution is not added.
5.6 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.
5.7 When exposed at (25,0 ± 1,0) 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.
The UV light to be used is the one described as per Annex A.
5.8 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 ISO 1974.
5.9 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 ISO 5636-3. For materials solely used for irradiation
sterilization, this requirement may be excluded.
5.10 The bursting strength of the conditioned paper shall be not less than 200 kPa when tested in
accordance with EN ISO 2758.
5.11 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. For materials solely used for irradiation sterilization, this
requirement may be excluded.
5.12 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 A.
5.13 When tested in accordance with Annex B, the average of the pore diameters of the ten test pieces
shall be lower or equal to 20 µm. No value shall be greater than 30 µm.
5.14 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.
5.15 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. For materials solely
used for irradiation sterilization, this requirement may be excluded.
5.16 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).
6 Sterilization compatibility
6.1 The sterilization processes applicable to the packaging materials under the scope of this document
shall be defined.
6.2 The sterilization compatibility of the packaging materials shall be evaluated following the
requirements of EN ISO 11607-1. The effects shall be evaluated considering the intended sterilization
process(es) and intended number of cycles.
NOTE Sterilization processes generally have an effect on material properties, therefore evaluation of
sterilization compatibility involves a risk-based assessment considering the characteristics of the material and its
application to define the properties to be evaluated, which typically include material strength properties relevant
for maintenance of sterility after sterilization.
7 Labelling
7.1 Transport packaging
The transport packaging shall be legibly and durably labelled. For industrial applications, the customer
and the supplier should agree on the required label information. For deliveries to health care facilities,
the label shall include at least 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 8601-1;
e) lot number ;
f) nominal mass in grams per square metre;
g) nominal sheet size or nominal width of rolls in millimetres and length in metres;
h) the recommended storage conditions.
7.2 Labelling of individual units
Individual units shall be legibly and durably labelled with the information a), b), d), e) and name or trade
name according to 7.1.
NOTE Examples for individual units are reels or stacks of sheet material.
8 Environmental declarations
8.1 Environmental labels and declarations, as applicable, shall be made in accordance with
EN ISO 14021 or EN ISO 14025.
NOTE Guidance on environmental aspects is provided in Annex D.
8.2 End-of-life treatment recommendations should be provided.
8.3 If an assessment of recyclability is performed, the following information shall be provided:
— information about the assessment methodology
— product reference under assessment
— standards and regulations used
— overall results and any additional information to be provided as required by the assessment
methodology.
A reference number in order to trace the manufacturing history of the product.
Annex A
(normative)
Method for the determination of water repellency
A.1 Apparatus
A.1.1 An ultraviolet light source and light meter with a range of wavelength of 315 nm to 390 nm.
A.1.2 Flat dish, approximately 200 mm x 150 mm x 15 mm.
A.1.3 Desiccator.
A.1.4 Stopwatch.
A.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.
A.1.6 Lux meter, calibrated to a known standard.
A.1.7 Room or chamber that can be sufficiently darkened.
A.2 Reagent
Dry indicator powder should be prepared as described below.
Grind (20,0 ± 1,0) 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,
nominal 108,0 °C, for a minimum of 24 h or until equilibrium is reached. Mix (10,0 ± 1,0) g sucrose with
(10,0 ± 1,0) mg 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 until used or a maximum of 30 days.
A.3 Environmental aspects of testing
A.3.1 Product samples
The number of samples and dimensions of the samples necessary should be carefully defined to avoid
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