kSIST FprEN 868-9:2026

• Abstract:

  This document specifies test methods and values for uncoated nonwoven materials of polyolefins used for single-use 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 series specifies materials, test methods and values that are specific to the products covered by this document.

• Status: Not Published
• Public Enquiry End Date: 30-Mar-2026
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 06-Oct-2026
• Due Date: 24-Nov-2026
• Completion Date: 06-Oct-2026
• Ref Project: FprEN 868-9 - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

• Revises: SIST EN 868-9:2019 - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
• Effective Date: 13-Nov-2024

Overview

kSIST FprEN 868-9:2026 is a draft European standard for packaging for terminally sterilized medical devices. It focuses on uncoated nonwoven materials of polyolefines used in single-use sterile barrier systems and packaging systems for medical devices that are sterilized at the final stage.

This document is part of the EN 868 series and is closely aligned with the core requirements of EN ISO 11607-1 and EN ISO 11607-2. Its purpose is to define the product-specific requirements, test methods, and values needed for these materials, while supporting safe use in healthcare and industrial sterilization environments.

As a draft standard, prEN 868-9:2026 will supersede EN 868-9:2018 once adopted. It also introduces updated guidance, including an expanded focus on environmental declarations and environmental aspects relevant to sterile barrier systems.

Key Topics

The standard addresses practical performance expectations for polyolefin nonwoven packaging materials used in medical device sterilization. Key topics include:

• Material requirements for uncoated nonwoven polyolefines
• Performance testing for characteristics relevant to sterile barrier systems
• Sterilization compatibility based on intended processes and cycle counts
• Labelling requirements for protective packaging
• Information to be provided for regulatory, technical, and environmental use

The document includes test methods related to properties such as:

• Mass per unit area
• Tearing resistance
• Delamination strength
• Air permeance
• Resistance to water penetration
• Tensile strength and bursting strength for specific material types

A notable feature of this revision is the inclusion of environmental declarations and an informative annex on environmental aspects, reflecting growing demand for sustainable medical packaging standards.

Applications

kSIST FprEN 868-9:2026 is relevant for manufacturers, suppliers, sterilization service providers, and healthcare organizations that use sterile packaging materials for terminally sterilized medical devices.

Typical applications include:

• Single-use sterile barrier systems
• Packaging systems for medical devices
• Healthcare facility sterilization workflows
• Industrial sterilization processes
• Material qualification and validation activities

The standard is especially useful when selecting and verifying uncoated nonwoven polyolefin materials for packaging that must maintain sterility up to the point of use. It also supports documentation, labelling, and environmental reporting obligations linked to modern medical packaging supply chains.

Related Standards

This document is part of a wider regulatory and technical framework for sterile medical packaging. Related standards include:

• EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems, and packaging systems
• EN ISO 11607-2 - Validation requirements for forming, sealing, and assembly processes
• EN ISO 14021 - Self-declared environmental claims
• EN ISO 14025 - Type III environmental declarations
• EN ISO 10993-1 - Biological evaluation of medical devices
• Other parts of the EN 868 series for sterile packaging materials and systems

For organizations seeking compliance with sterilized packaging standards, prEN 868-9:2026 provides a focused reference for evaluating uncoated polyolefin nonwoven materials used in terminal sterilization packaging.

SLOVENSKI STANDARD
oSIST prEN 868-9:2026
01-marec-2026
Embalaža za končno sterilizirane medicinske pripomočke - 9. del: Površinsko
neobdelani netkani materiali iz poliolefinov - Zahteve in preskusne metode
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven
materials of polyolefines - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 9:
Unbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und
Prüfverfahren
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 9 : Matériaux
non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: prEN 868-9
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN 868-9:2026 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN 868-9:2026
oSIST prEN 868-9:2026
DRAFT
EUROPEAN STANDARD
prEN 868-9
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2026
ICS 11.080.30 Will supersede EN 868-9:2018
English Version
Packaging for terminally sterilized medical devices - Part
9: Uncoated nonwoven materials of polyolefines -
Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 9 : Matériaux non tissés à base de sterilisierende Medizinprodukte - Teil 9:
polyoléfines, non enduits - Exigences et méthodes Unbeschichtete Faservliesmaterialien aus Polyolefinen
d'essai - 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, 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.
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: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-9:2026 E
worldwide for CEN national Members.

oSIST prEN 868-9:2026
prEN 868-9:2026 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General requirements . 6
4.1 General . 6
4.2 Materials . 6
5 Performance requirements and test methods . 6
5.1 General . 6
5.2 Specific performance requirements for polyethylene based materials. 7
5.3 Specific perform ace requirements for polypropylene based materials . 7
6 Sterilization compatibility . 7
7 Labelling of the protective packaging . 7
8 Information to be provided . 8
8.1 Regulatory and technical information . 8
8.2 Environmental declarations . 8
Annex A (informative) Environmental aspects . 9
Bibliography . 12
oSIST prEN 868-9:2026
prEN 868-9:2026 (E)
European foreword
This document (prEN 868-9:2026) 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 document is currently submitted to the CEN Enquiry.
This document will supersede EN 868-9:2018.
prEN 868-9:2026 includes the following significant technical changes with respect to EN 868-9:2018:
a) 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 acceptance criteria apply.
b) Clause 8 “Environmental declarations” was added and aligned with the other parts of EN 868 series.
c) 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.
d) New Annex A regarding environmental aspects was added.
EN 868 series 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 constructed of porous materials and plastic film— 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 large steam sterilizers — Requirements and test methods;
— Part 9: Uncoated nonwoven materials of polyolefins — Requirements and test methods;
— Part 10: Adhesive coated nonwoven materials of polyolefins — Requirements and test methods.
oSIST prEN 868-9:2026
prEN 868-9:2026 (E)
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 [2].
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 9 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 [4] 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.
oSIST prEN 868-9:2026
prEN 868-9:2026 (E)
1 Scope
This document specifies test methods and values for uncoated nonwoven materials of polyolefins used
for single-use 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 series 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 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)
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 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
ASTM D2724, Standard Test Methods for Bonded, Fused, and Laminated Apparel Fabrics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2020 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:

As impacted by EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-1:2020/A11:2022.
oSIST prEN 868-9:2026
prEN 868-9:2026 (E)
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
4 General requirements
4.1 General
4.1.1 For any material, preformed sterile barrier system or sterile barrier system, the requirements of
EN ISO 11607-1 shall apply.
4.1.2 Polyethylene and polypropylene non-wovens have different specific performance requirements
and this shall be considered during design and use of sterile barrier systems for specific applications.
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, 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.
4.1.3 This part of EN 868 series only introduces performance requirements and test methods that are
specific to the products covered by this part of EN 868 series but does not add or modify the general
requirements specified in EN ISO 11607-1.
4.1.4 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 Conformity with this document does not automatically mean conformity with EN ISO 11607-1.
4.1.5 A confirmation of compliance to this document shall contain a statem
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