Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with FprEN 868 9 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 10: Klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und Prüfverfahren

Dieses Dokument legt Prüfverfahren und Werte für klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen fest, hergestellt aus Faservliesmaterialien nach FprEN 868 9, und 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 10 : Matériaux non tissés à base de polyoléfines enduits d’adhésif - 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, enduits d’adhésif, fabriqués à partir de non-tissés conformément au FprEN 868 9, et utilisés comme systèmes de barrière stérile et/ou comme 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 - 10. del: Netkani materiali iz poliolefinov, oplemeniteni z lepilom - Zahteve in preskusne metode

Ta dokument določa preskusne metode in vrednosti za netkane materiale iz poliolefinov, oplemenitene z lepilom, izdelane v skladu s standardom EN 868-9, 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, zajete v tem dokumentu.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.

General Information

Status
Published
Publication Date
18-Dec-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
19-Dec-2018
Completion Date
19-Dec-2018

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SLOVENSKI STANDARD
SIST EN 868-10:2019
01-marec-2019
1DGRPHãþD
SIST EN 868-10:2009
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO1HWNDQL
PDWHULDOLL]SROLROHILQRYRSOHPHQLWHQL]OHSLORP=DKWHYHLQSUHVNXVQHPHWRGH

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven

materials of polyolefines - Requirements and test methods

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 10:

Klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und

Prüfverfahren

Matériaux et systèmes d’emballage pour les dispositifs médicaux stérilisés au stade

terminal - Partie 10 : Matériaux non tissés à base de polyoléfines enduits d’adhésif -

Exigences et méthodes d’essai
Ta slovenski standard je istoveten z: EN 868-10:2018
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN 868-10:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 868-10:2019
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SIST EN 868-10:2019
EN 868-10
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-10:2009
English Version
Packaging for terminally sterilized medical devices - Part
10: Adhesive coated nonwoven materials of polyolefines -
Requirements and test methods

Matériaux et systèmes d'emballage pour les dispositifs Verpackungen für in der Endverpackung zu

médicaux stérilisés au stade terminal - Partie 10 : sterilisierende Medizinprodukte - Teil 10:

Matériaux non tissés à base de polyoléfines enduits Klebemittelbeschichtete Faservliesmaterialien aus

d'adhésif - Exigences et méthodes d'essai Polyolefinen - 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 868-10:2018 E

worldwide for CEN national Members.
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SIST EN 868-10:2019
EN 868-10:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 6

4 Requirements ................................................................................................................................................... 6

5 Information to be supplied by the manufacturer ................................................................................ 8

Annex A (informative) Details of significant technical changes between this European

Standard and the previous edition ........................................................................................................... 9

Annex B (normative) Method for the determination of mass per unit area of uncoated

nonwoven polyolefine materials and adhesive coating ................................................................. 10

Annex C (normative) Method for the determination of seal strength and mode of specimen

failure ............................................................................................................................................................... 12

Bibliography ................................................................................................................................................................. 14

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SIST EN 868-10:2019
EN 868-10:2018 (E)
European foreword

This document (EN 868-10:2018) 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 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 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 868-10:2009.

Annex A provides details of significant technical changes between this European Standard 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.
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SIST EN 868-10:2019
EN 868-10:2018 (E)
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 processes.

General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1.

The EN 868 series can be used to demonstrate compliance with one or more of the requirements

specified in EN ISO 11607-1.

CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse

environmental impacts by standards. It was agreed that this subject should be given priority during the

next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series.

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SIST EN 868-10:2019
EN 868-10:2018 (E)
1 Scope

This document specifies test methods and values for sealable adhesive coated nonwoven materials of

polyolefines, manufactured from nonwovens complying with EN 868-9 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

document.
The materials specified in this part of EN 868 are intended for single use only.
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)

ISO 811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test

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 11607-1:2017, Packaging for terminally sterilized medical devices — Part 1: Requirements for

materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)

ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen

method

ISO 6588-2, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot extraction

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates

and times

ASTM D2724, Standard Test Methods for Bonded, Fused, and Laminated Apparel Fabrics

ASTM F88/F88M:2015, Standard Test Method for Seal Strength of Flexible Barrier Materials

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SIST EN 868-10:2019
EN 868-10:2018 (E)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2017 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
4 Requirements
4.1 General

For any material, preformed sterile barrier system or sterile barrier system, the requirements of

EN ISO 11607-1 shall apply.

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.
As such, the pa
...

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