EN 868-9:2018

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

This document specifies test methods and values for uncoated nonwoven materials of polyolefines used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
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 European Standard.
The materials specified in this part of EN 868 are intended for single use only.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 9: Unbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für unbeschichtete Faservliesmaterialien aus Polyolefinen fest, die dazu bestimmt sind, als Sterilbarrieresysteme und/oder Verpackungssysteme die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607 1 und EN ISO 11607 2 festgelegt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, welche spezifisch für die in dieser Europäischen Norm betrachteten Produkte sind.
Die nach diesem Teil von EN 868 festgelegten Materialien sind nur für den einmaligen Gebrauch vorgesehen.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 9 : Matériaux non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai

Le présent document spécifie des méthodes d’essai et des valeurs relatives aux matériaux non tissés à base de polyoléfines, non enduits, utilisés dans des systèmes de barrière stérile et/ou des systèmes d’emballage destinés à maintenir l’état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu’au point d’utilisation.
Outre les exigences générales telles que spécifiées dans l’EN ISO 11607 1 et l’EN ISO 11607 2, la présente partie de l’EN 868 spécifie les matériaux, les méthodes d’essai et les valeurs spécifiques aux produits traités dans la présente Norme européenne.
Les matériaux spécifiés dans la présente partie de l’EN 868 sont destinés exclusivement à un usage unique.

Embalaža za končno sterilizirane medicinske pripomočke - 9. del: Površinsko neobdelani netkani materiali iz poliolefinov - Zahteve in preskusne metode

Ta dokument določa preskusne metode in vrednosti za površinsko neobdelane netkane materiale iz poliolefinov, ki se uporabljajo kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
Razen splošnih zahtev, ki so določene v standardih EN ISO 11607-1 in EN ISO 11607-2, ta del standarda EN 868 določa materiale, preskusne metode in vrednosti, ki so specifične za izdelke, ki jih zajema ta dokument.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.

General Information

• Status: Published
• Publication Date: 18-Dec-2018
• Withdrawal Date: 29-Jun-2019
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
• Start Date: 11-Nov-2024
• Completion Date: 14-Apr-2025
• Ref Project: SIST EN 868-9:2019 - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

Relations

• Replaces: EN 868-9:2009 - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
• Effective Date: 08-Jun-2022

Overview

EN 868-9:2018 - "Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods" is a CEN European Standard that specifies material requirements, test methods and acceptance values for uncoated polyolefin nonwoven materials used in sterile barrier systems and packaging systems. These materials are intended for single use and for maintaining sterility of terminally sterilized medical devices up to the point of use.

Key topics and technical requirements

This part complements the general requirements of EN ISO 11607-1 and EN ISO 11607-2 by providing product-specific test methods and limits for polyolefin nonwovens (polyethylene and polypropylene).

Important technical requirements include:

• Material purity and biocompatibility considerations (see EN ISO 10993-1).
• No colour leaching: verified by a hot extract test (ISO 6588-2 method modified to 60 ± 5 °C).
• Mass tolerance: average mass per m² within ±7% of manufacturer’s nominal value (EN ISO 536).
• Internal tearing resistance: ≥ 1000 mN (machine and cross directions, EN ISO 1974).
• Delamination factor (if applicable): ≥ 1 N/25.4 mm (ASTM D2724).
• Air permeance: ≥ 1 µm/Pa·s at 1.47 kPa (ISO 5636-3) - can be omitted for materials intended only for irradiation sterilization.
• Water resistance: hydrostatic head test per EN ISO 811 (document test conditions/results).
• Specific mechanical performance:
  • Polyethylene-based: tensile strength ≥ 4.8 kN/m (machine), ≥ 5.0 kN/m (cross); bursting strength ≥ 575 kPa.
  • Polypropylene-based: tensile strength ≥ 2.5 kN/m (machine), ≥ 1.5 kN/m (cross); bursting strength ≥ 400 kPa.
• Marking: packaging must show reference/lot number, quantity, manufacturer name/address, manufacture date (ISO 8601), nominal mass (g/m²), nominal size or roll width/length, and storage conditions.

Applications and users

EN 868-9 is practical for:

• Manufacturers of sterile barrier systems and single-use medical device packaging using polyolefin nonwovens.
• Packaging engineers, quality managers and regulatory teams verifying compliance with sterile packaging standards.
• Test laboratories performing mechanical, permeance and extract tests for medical packaging qualification.
• Procurement and validation teams selecting materials for steam, EO or irradiation terminal sterilization.

Related standards

• EN ISO 11607-1 / EN ISO 11607-2 (general requirements and validation for terminally sterilized device packaging)
• EN 868 series (other parts for wraps, papers, pouches, containers)
• EN ISO 10993-1 (biological evaluation)
• Relevant test standards cited within EN 868-9 (EN ISO 536, EN ISO 1974, ISO 5636-3, EN ISO 811, EN ISO 1924-2, EN ISO 2758, ASTM D2724)

Keywords: EN 868-9:2018, polyolefin nonwoven, sterile barrier systems, medical device packaging, test methods, polyethylene, polypropylene, sterile packaging standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2019
1DGRPHãþD
SIST EN 868-9:2009
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3RYUãLQVNR
QHREGHODQLQHWNDQLPDWHULDOLL]SROLROHILQRY=DKWHYHLQSUHVNXVQHPHWRGH
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
Matériaux et systèmes d’emballage pour les 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: EN 868-9:2018
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 868-9
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-9:2009
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 European Standard was approved by CEN on 19 October 2018.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-9:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements . 6
4.1 General . 6
4.2 Materials . 6
4.3 Performance requirements and test methods . 6
4.3.1 General . 6
4.3.2 Specific performance requirements and test methods . 7
4.4 Marking of the protective packaging . 7
5 Information to be supplied by the manufacturer . 7
Annex A (informative) Details of significant technical changes between this document and
the previous edition . 8
Bibliography . 9

European foreword
This document (EN 868-9:2018) 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 shall be given the status of a national standard, either by publication of an identical text
or by endorsement, at the latest by June 2019, and conflicting national standards shall be withdrawn at
the latest by June 2019.
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 868-9:2009.
Annex A provides details of significant technical changes between this document and the previous
edition.
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.
In addition, ISO/TC 198 “Sterilization of health care products” in collaboration with CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” has prepared the
EN ISO 11607 series “Packaging for terminally sterilized medical devices”. The EN ISO 11607 series
specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1)
and validation requirements for forming, sealing and assembly processes (Part 2).
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Introduction
The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally
sterilized medical devices”. Part 1 of this series 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. Part 2 of this
series specifies validation requirements for forming, sealing and assembly proces
...