kSIST FprEN 868-9:2026
(Main)Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
- 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
- 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
kSIST FprEN 868-9:2026 is the SIST version of the draft European Standard prEN 868-9:2026. It covers packaging for terminally sterilized medical devices and specifies test methods and product-specific performance values for uncoated nonwoven materials of polyolefins used in single-use sterile barrier systems and packaging systems. The document is for manufacturers, test laboratories, and users who need to qualify, specify, or verify this material for sterile packaging.
What does kSIST FprEN 868-9:2026 specify?
kSIST FprEN 868-9:2026 specifies the material-specific requirements for uncoated nonwoven polyolefin materials, while the general requirements come from EN ISO 11607-1 and EN ISO 11607-2. It is organized into clauses on scope, normative references, terms and definitions, general requirements, performance requirements and test methods, sterilization compatibility, labelling, and information to be provided, plus one informative annex on environmental aspects.
The document focuses on materials used for single-use sterile barrier systems and/or packaging systems for terminally sterilized medical devices. It also notes that these materials can be used in health care facility sterilization processes and, in some cases, in industrial sterilization.
What are the key requirements of kSIST FprEN 868-9:2026?
kSIST FprEN 868-9:2026 sets out the product checks that matter for selecting, testing, and documenting uncoated nonwoven polyolefins. In practice, the user has to show that the material performs as declared, remains suitable after sterilization, and is labelled and documented correctly.
General material and test conditions
Clause 4 requires the general EN ISO 11607-1 requirements to be met and notes that polyethylene and polypropylene non-wovens have different specific performance requirements. The material has to be translucent or opaque, made of continuous polyolefin filaments of high purity, and not release substances in amounts that could create a health risk.
Clause 4 also sets the testing basis for conditioned samples and says that the standard only adds the product-specific requirements for this material family. For users, that means this part cannot be read alone as a full sterile packaging specification.
Performance checks in Clause 5
Clause 5 covers the core performance tests. It checks that colour does not leach from the material, that the declared mass per unit area is met within the allowed tolerance, and that tear resistance is sufficient in both machine and cross directions.
Clause 5 also covers delamination, air permeance, and water penetration. If delamination can be initiated, the material must resist layer separation; air permeance is required for the material as conditioned; and water penetration is checked with a hydrostatic head method, with the test result and conditions documented.
Polymer-specific strength requirements
Clause 5 separates polyethylene-based and polypropylene-based materials because their strength behaviour is different. Polyethylene-based materials have their own tensile and bursting strength requirements, and polypropylene-based materials have a different set of tensile and bursting strength requirements.
For buyers and designers, this means the polymer type is not just a material description - it changes the acceptance criteria and should be matched to the sterilization process and package design.
Sterilization, labelling, and information
Clause 6 requires the sterilization processes to be defined and the compatibility of the packaging material to be evaluated using the EN ISO 11607-1 approach, considering the intended process or processes and number of cycles. Clause 7 requires durable, legible labelling, and for deliveries to health care facilities it names the key label data to provide, including identification, quantity, manufacturer or supplier details, date of manufacture, lot number, nominal mass, size or roll dimensions, and storage conditions where relevant.
Clause 8 covers information to be provided with the material. It includes regulatory and technical information for sterile barrier system use, environmental labels and declarations, end-of-life recommendations, and, where recyclability is assessed, the method used, the product reference, the standards and regulations applied, and the results.
What terms does kSIST FprEN 868-9:2026 define?
Clause 3 uses the terms and definitions from EN ISO 11607-1:2020. Key terms used in the document include:
- sterile barrier system (SBS) - the packaging barrier intended to maintain sterility until point of use.
- packaging system - the wider packaging arrangement used with the sterile barrier system.
- protective packaging - the outer packaging that has to be legibly and durably labelled.
- machine direction - the main direction of the material used for tensile and tear testing.
- cross direction - the direction across the material width used for tensile and tear testing.
- delamination strength - resistance to layers separating when delamination can be initiated.
- environmental declaration - a claim or declaration made under EN ISO 14021 or EN ISO 14025.
Who uses kSIST FprEN 868-9:2026?
kSIST FprEN 868-9:2026 is used by manufacturers of sterile packaging materials, designers of sterile barrier systems, testing laboratories, and quality or regulatory teams. It is also relevant to buyers and suppliers who need to agree material specifications, label content, and documentation for delivery to health care facilities or industrial users.
What changed in kSIST FprEN 868-9:2026 from the previous edition?
kSIST FprEN 868-9:2026 will supersede EN 868-9:2018. The foreword states that Clause 4 was revised for clarity and alignment with the EN 868 series, Clause 8 on environmental declarations was added, the former annex with significant technical changes was deleted, and a new Annex A on environmental aspects was added.
Which standards are used with kSIST FprEN 868-9:2026?
| Standard | What it contributes |
|---|---|
| EN ISO 11607-1 | General requirements for materials, sterile barrier systems, and packaging systems |
| EN ISO 11607-2 | Validation requirements for forming, sealing, and assembly processes |
| EN ISO 536 | Grammage determination |
| EN ISO 811 | Water penetration resistance by hydrostatic pressure |
| EN ISO 1924-2 | Tensile properties |
| EN ISO 1974 | Tearing resistance |
| EN ISO 2758 | Bursting strength |
| EN ISO 14021 | Self-declared environmental claims |
| EN ISO 14025 | Type III environmental declarations |
| ISO 5636-3 | Air permeance |
| ISO 6588-2 | Hot extraction method used for the colour-leach check |
| ISO 8601-1 | Date format for labelling |
| ASTM D2724 | Delamination strength test |
The bibliography also points to EN ISO 10993-1, ISO 22095, and CEN Guide 4.
What does the kSIST FprEN 868-9:2026 document contain?
kSIST FprEN 868-9:2026 brings together test methods for colour leaching, mass per area, tear resistance, delamination, air permeance, water penetration, tensile strength, and bursting strength. It also sets out the sterilization compatibility approach, the required package labelling data, and the environmental information that should accompany the material.
Annex A gives guidance on environmental aspects across the lifecycle, including material use, production, transport packaging, end-of-life treatment, and transportation. The bibliography links the document to related guidance on biocompatibility, chain of custody, and environmental issues.
Relations
- Effective Date
- 13-Nov-2024
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Frequently Asked Questions
kSIST FprEN 868-9:2026 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods". This standard covers: 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.
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.
kSIST FprEN 868-9:2026 is classified under the following ICS (International Classification for Standards) categories: 11.080.30 - Sterilized packaging. The ICS classification helps identify the subject area and facilitates finding related standards.
kSIST FprEN 868-9:2026 has the following relationships with other standards: It is inter standard links to SIST EN 868-9:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
kSIST FprEN 868-9:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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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