SIST EN 868-2:2025

SLOVENSKI STANDARD
01-junij-2025
Nadomešča:
SIST EN 868-2:2017
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Sterilizacijski
embalažni materiali za zavijanje - Zahteve in preskusne metode
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap -
Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Sterilisierverpackung - Anforderungen und Prüfverfahren
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : Enveloppe
de stérilisation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-2:2025
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 868-2
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2025
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-2:2017
English Version
Packaging for terminally sterilized medical devices - Part
2: Sterilization wrap - Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 2 : Enveloppe de stérilisation - sterilisierende Medizinprodukte - Teil 2:
Exigences et méthodes d'essai Sterilisierverpackung - 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 868-2:2025 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 . 8
5.1 General. 8
5.2 Specific requirements for wrap made of creped paper . 8
5.3 Specific requirements for wrap made of nonwoven material . 9
5.4 Specific requirements for wrap made of woven textile material . 9
6 Sterilization compatibility . 10
7 Labelling . 10
7.1 General. 10
7.2 Sales packaging . 10
7.3 Inner packaging . 10
8 Information to be provided . 11
8.1 Application of the sterilization wrap . 11
8.2 Environmental declarations . 11
Annex A (informative) Method for the determination of drape . 12
Annex B (normative) Method for the determination of water repellency . 14
Annex C (normative) Method for the determination of pore size . 17
Annex D (informative) Repeatability and reproducibility of test methods . 22
Annex E (informative) Environmental aspects . 24
Bibliography . 27

European foreword
This document (EN 868-2:2025) 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 868-2:2017.
a) The scope has been revised for clarity; plain paper has been removed as material for sterilization
wrap.
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
the EN 868 series, and a statement was added clarifying when requirements apply.
d) Clause 5 “Performance requirements and test methods”: materials used solely for irradiation
sterilization are excluded from the requirements regarding wet tensile strength of the wrap.
e) Clause 6 “Sterilization compatibility” was added and aligned with the other parts of the EN 868
series.
f) Subclause 8.2 “Environmental declarations” was added and aligned with the other parts of EN 868
series.
g) 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.
h) New Clause “Environmental aspects for testing” was added to each test method in Annexes A to C.
i) New Annex E 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 and
EN ISO 11607-2 [1].
The EN 868 series of standards have been developed mainly for materials and sterile barrier systems
used in health care facilities sterilization processes. 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 [2] 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 sterilization wrap made of
— single-use creped paper
— single-use nonwoven materials
— reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
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
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 536, Paper and board — Determination of grammage (ISO 536)
EN ISO 811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test (ISO
811)
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 2758:2014)
EN ISO 9073-3, Nonwovens — Test methods — Part 3: Determination of tensile strength and elongation at
break using the strip method (ISO 9073-3)
EN ISO 9237, Textiles — Determination of permeability of fabrics to air (ISO 9237)
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 13937-1, Textiles — Tear properties of fabrics — Part 1: Determination of tear force using ballistic
pendulum method (Elmendorf) (ISO 13937-1)
EN ISO 13938-1, Textiles — Bursting properties of fabrics — Part 1: Hydraulic method for determination
of bursting strength and bursting distension (ISO 13938-1)
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 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.
NOTE 1 This document introduces test methods in Annex A, Annex B and Annex C. Annex D provides a statement
on the repeatability and reproducibility of the test methods in Annex B and Annex C, as well as for those of sulfate
content and chloride content.
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 2 Compliance with EN 868-2 does not automatically mean compliance to EN ISO 11607-1.
4.3 All requirements in Clause 5 shall be applied for testing materials before sterilization.
4.4 A confirmation of compliance to EN 868-2 shall contain a statement of whether EN ISO 11607-1 is
covered.
5 Performance requirements and test methods
5.1 General
5.1.1 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.
5.1.2 The average mass of 1 m of the conditioned wrap when tested in accordance with EN ISO 536 shall
be within ± 5 % of the nominal value stated by the manufacturer.
5.1.3 The pH of an aqueous extract of the wraps shall be not less than 5 or greater than 8 when tested in
accordance with ISO 6588-2, hot extraction method.
5.1.4 The chloride content of the wrap, 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.
5.1.5 The sulfate content of the wrap, 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.
5.1.6 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.
5.1.7 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.
The UV light to be used is the one described as per Annex B.
5.1.8 Drapeability results and associated test methods shall be provided on request.
NOTE For test method, see e.g. EN ISO 9073-9 [3] or Annex A.
5.2 Specific requirements for wrap made of creped paper
5.2.1 The wrap shall be creped to give increased flexibility.
5.2.2 The elongation at break of the conditioned wrap shall be not less than 10 % in the machine direction
and not less than 2 % in the cross direction when tested by measurement of the elongation in conjunction
with the test for tensile strength in accordance with EN ISO 1924-2.
5.2.3 The water repellency of the wrap shall be such that the penetration time is not less than 20 s when
tested in accordance with Annex B.
5.2.4 When tested in accordance with Annex C, the average of the pore diameters of the ten test pieces
shall be lower than or equal to 35 μm. No value shall be greater than 50 μm.
5.2.5 The tensile strength of the conditioned wrap shall be not less than 1,33 kN/m in machine direction
and not less than 0,67 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
5.2.6 The wet tensile strength of the wrap shall be not less than 0,33 kN/m in machine direction and not
less than 0,27 kN/m in cross direction when tested in accordance with ISO 3781. For materials solely
used for irradiation sterilization, this requirement may be excluded.
5.3 Specific requirements for wrap made of nonwoven material
5.3.1 The internal tearing resistance of the conditioned nonwoven wrap shall be not less than 750 mN in
the machine direction and 1 000 mN in the cross direction when tested in accordance with EN ISO 1974.
5.3.2 The bursting strength of the conditioned nonwoven wrap shall be not less than 130 kPa when tested
in accordance with EN ISO 2758.
5.3.3 The wet bursting strength of the nonwoven wrap shall be not less than 90 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.
5.3.4 The elongation at break of the conditioned nonwoven wrap shall be not less than 5 % in the machine
direction and not less than 7 % in the cross direction when tested in accordance with EN ISO 1924-2.
5.3.5 The resistance to water penetration of the nonwoven wrap shall be determined using the
hydrostatic head test based on EN ISO 811. The test shall be performed at a velocity of 60 cm/min ± 5 %,
with a minimum requirement of 30 cm. Test parameters and results shall be documented.
5.3.6 The tensile strength of the conditioned nonwoven wrap shall be not less than 1,00 kN/m in machine
direction and not less than 0,65 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
5.3.7 The wet tensile strength of the nonwoven wrap shall be not less than 0,75 kN/m in machine
direction and not less than 0,50 kN/m in cross direction when tested in accordance with ISO 3781. For
materials solely used for irradiation sterilization, this requirement may be excluded.
5.4 Specific requirements for wrap made of woven textile material
5.4.1 Requirements for the processing of reusable fabrics, as given in EN ISO 11607-1:2020, 5.1.11 and
5.1.12, apply and shall include the means to quantify and control the number of processing cycles.
5.4.2 The tensile strength, “dry” and “wet”, of the wrap shall be not less than 300 N in the warp and weft
directions when tested in accordance with strip method of EN ISO 9073-3.
5.4.3 The tear strength, “dry” and “wet”, of the wrap shall be not less than 6 N in the warp and weft
directions when tested in accordance with EN ISO 13937-1. The samples for the “wet” test shall be
prepared according to EN ISO 9073-3.
5.4.4 The bursting strength “dry” and “wet” of the wraps shall not be less than 100 kPa when tested in
accordance with EN ISO 13938-1. The preparation of samples for wet state testing shall be performed in
accordance with EN ISO 9073-3.
5.4.5 The air permeability of the wrap shall be not more than 20 mm/s when tested in accordance with
EN ISO 9237. For materials solely used for irradiation sterilization, this requirement may be excluded.
5.4.6 The resistance to water penetration of the woven textile material shall be determined using the
hydrostatic head test based on EN ISO 811. The test shall be performed at a velocity of 60 cm/min ± 5 %,
with a minimum requirement of 30 cm. Test conditions and test results shall be documented.
NOTE Caution is given regarding microbial properties of some currently available woven materials made of
cotton (linen). Available data [4] on microbial barrier properties measured on a single layer of material after the
first use and after one washing for reuse indicate very low barrier properties, such that these materials are not
recommended by organisations like WFHSS (World Federation for Hospital Sterilization Sciences). Microbial
properties were measured by DIN 58953-6 [5] and by the barrier efficiency test ASTM F2101 [6].
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 General
7.1.1 The sales and inner packaging shall be labelled with the information necessary for its identification
to support traceability.
7.1.2 Where available, validated symbols in accordance with EN ISO 15223-1 [7] should be used.
NOTE Regulatory requirements apply to labelling and marking and generally include aspects like name of the
manufacturer, trade name, UDI etc.
7.2 Sales packaging
The sales 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) name or trade name and address of the manufacturer;
d) date of manufacture in accordance with ISO 8601-1;
e) lot number ;
f) nominal sheet size or nominal width of rolls in millimetres and length in metres;
g) the recommended storage conditions;
h) whether sterilization wrap is intended for single use only.
7.3 Inner packaging
The inner package with sheets or inner label with reels shall be provided with the information a), b), d),
e) and f) according to 7.2 in a legible and durable way.

A reference number in order to trace the manufacturing history of the product.
8 Information to be provided
8.1 Application of the sterilization wrap
The following information should be supplied in addition to EN ISO 11607-1:2020, Clause 11:
a) type of material used for the sterilization wrap
NOTE 1 A nonwoven material for sterile barrier systems can be manufactured by different technologies,
e.g. wet laid nonwoven processes or Spunbond Meltblown Spunbond (SMS) processes.
b) recommendations for particular applications of the sterilization wrap (e.g. sterile barrier system,
transport packaging, packaging system);
c) the nature and extent of any identified risks associated with the use of the packaging material
and/or system;
d) any information pertinent to the packaged medical device as may be required (see EN ISO 20417
[8]).
NOTE 2 For requirements on information to be provided by the manufacturer, national or regional legislation
can apply, see in particular Regulation (EU) 2017/745, Annex I, Chapter III, Section 23 [9].
8.2 Environmental declarations
8.2.1 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 E.
8.2.2 End-of-life treatment recommendations should be provided.
8.2.3 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.
Annex A
(informative)
Method for the determination of drape
A.1 Apparatus
A.1.1 Softness tester
Softness tester comprising a clamp formed by a pair of flat jaws or rollers, designed to grip the end of a
25 mm wide strip of paper along a horizontal axis at right angles to its length, and mounted on a spindle
to enable the clamped end of the strip to be rotated about the spindle axis.
The edges of the clamping surfaces shall be
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