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 bur
...