EN 868-2:2017
(Main)Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
This draft European Standard provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
The need for a protective packaging may be determined by the manufacturer and the user.
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 particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, 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, may apply.
The materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Sterilisierverpackung - Anforderungen und Prüfverfahren
Dieser europäische Norm-Entwurf enthält Prüfverfahren und Werte für Materialien, die dazu vorgesehen sind, als Sterilbarrieresysteme und/oder Verpackungssysteme die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Die Erfordernis für eine Schutzverpackung darf durch den Hersteller und den Anwender bestimmt werden.
Dieser Teil von EN 868 enthält lediglich Leistungsanforderungen und Prüfverfahren, die spezifisch für die Produkte nach diesem Teil von EN 868 sind, ergänzt oder modifiziert jedoch nicht die in EN ISO 11607-1 festgelegten allgemeinen Anforderungen.
Die besonderen Anforderungen nach 4.2 können daher verwendet werden, um Übereinstimmung mit einer oder mehreren Anforderung(en) - aber nicht mit allen Anforderungen - der EN ISO 11607-1 nachzuweisen.
Werden zusätzliche Materialien im Sterilbarrieresystem verwendet, um die Organisation, die Trocknung oder die aseptische Präsentation zu erleichtern (z. B. Innenverpackung, Filter für Sterilisier¬behälter, Indikatoren, Verpackungslisten, Unterlagen, Einsätze für Instrumente, Fächer oder eine zusätzliche Umhüllung für das Medizinprodukt), dann können andere Anforderungen, einschließlich der Bestimmung der Eignung dieser Materialien im Rahmen von Validierungstätigkeiten, gelten.
Die nach 4.2.2.1 bis 4.2.2.3 dieses Teils von EN 868 festgelegten Materialien sind für den einmaligen Gebrauch vorgesehen, die nach 4.2.2.4 festgelegten Materialien sind für die Wiederverwendung vorgesehen.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Enveloppe de stérilisation - Exigences et méthodes d'essai
Le présent projet de Norme européenne fournit des méthodes d'essai et des valeurs applicables aux matériaux 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'à leur utilisation.
La nécessité d’un emballage de protection peut être déterminée par le fabricant et l’utilisateur.
La présente partie de l’EN 868 présente uniquement les exigences de performance et les méthodes d’essai spécifiques aux produits couverts par la présente partie de l’EN 868, mais elle n'ajoute pas ou ne modifie pas les exigences générales spécifiées dans l’EN ISO 11607-1.
En conséquence, les exigences particulières mentionnées en 4.2 peuvent être utilisées pour démontrer la conformité à une ou plusieurs exigences de l’EN ISO 11607-1, mais pas à la totalité.
En cas d'utilisation de matériaux complémentaires à l’intérieur du système de barrière stérile de manière à faciliter le rangement, le séchage ou la présentation aseptique (par exemple, enveloppe interne, filtre de conteneur, indicateurs, inventaires d’emballage, matelas de support silicone ou autres plastiques, kits d’organisation des instruments médicaux, fonds de protection de panier ou une enveloppe supplémentaire contenant le dispositif médical), d’autres exigences peuvent alors s’appliquer, y compris la détermination de l’acceptabilité de ces matériaux lors des activités de validation.
Les matériaux spécifiés en 4.2.2.1 à 4.2.2.3 de la présente partie de l’EN 868, sont destinés à un usage unique ; les matériaux spécifiés en 4.2.2.4 sont destinés à être réutilisés.
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Sterilizacijski embalažni materiali za zavijanje - Zahteve in preskusne metode
Ta osnutek evropskega standarda podaja preskusne metode in vrednosti za materiale za sterilne pregradne sisteme in/ali sisteme embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik.
Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki se uporabljajo za proizvode, zajete v tem delu standarda EN 868, vendar ne dodaja ali spreminja splošnih zahtev, podanih v standardu EN ISO 11607-1.
Posebne zahteve iz točke 4.2 se lahko uporabljajo za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, filtrirni vsebnik, kazalniki, embalažni listi, podloge, kompleti organizatorjev za inštrumente, obloge za pladnje ali dodatni ovoj okoli medicinskega pripomočka), se lahko uporabljajo druge zahteve, vključno z ugotavljanjem sprejemljivosti teh materialov med preverjanjem.
Materiali, podani v točkah od 4.2.2.1 do 4.2.2.3 tega dela standarda EN 868, so namenjeni za enkratno uporabo, materiali, podani v točki 4.2.2.4 pa so namenjeni za ponovno uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2017
1DGRPHãþD
SIST EN 868-2:2009
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO 6WHULOL]DFLMVNL
HPEDODåQLPDWHULDOL]D]DYLMDQMH=DKWHYHLQSUHVNXVQHPHWRGH
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
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 2 : Enveloppe de stérilisation - Exigences et méthodes d'essai
Ta slovenski standard je istoveten z: EN 868-2:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
55.040 0DWHULDOLLQSULSRPRþNL]D Packaging materials and
SDNLUDQMH accessories
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 868-2
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-2:2009
English Version
Packaging for terminally sterilized medical devices - Part
2: Sterilization wrap - Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungsmaterialien 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 4 December 2016.
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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-2:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements . 7
5 Information to be supplied by the manufacturer . 11
Annex A (informative) Details of significant technical changes between this European
Standard and the previous edition . 12
Annex B (informative) Method for the determination of drape . 13
B.1 Apparatus . 13
B.1.1 Softness tester . 13
B.1.2 Rule . 13
B.2 Procedure. 13
B.3 Test report . 13
Annex C (normative) Method for the determination of water repellency . 14
C.1 Apparatus . 14
C.2 Reagent . 14
C.3 Procedure. 14
C.4 Repeatability and reproducibility. 14
C.5 Test report . 15
Annex D (normative) Method for the determination of pore size . 16
D.1 Principle . 16
D.2 Test liquid . 16
D.3 Apparatus . 16
D.4 Preparation of test specimens . 18
D.5 Procedure. 18
D.6 Result . 19
D.6.1 Calculation and expression of results . 19
D.6.2 Derivation of formula for calculation of equivalent pore radius . 19
D.7 Repeatability and reproducibility. 20
D.8 Test report . 20
Annex E (informative) Repeatability and reproducibility of test methods . 21
Bibliography . 23
European foreword
This document (EN 868-2:2017) 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 August 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
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 868-2:2009.
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 series
EN ISO 11607 “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 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.
1 Scope
This European Standard specifies test methods and values for materials 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.
While materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the
materials specified in 4.2.2.4 are intended for reuse.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 20187, Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for
monitoring the atmosphere and conditioning of samples (ISO 187)
EN 20811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test (ISO
811)
EN 29073-3, Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and
elongation (ISO 9073-3)
EN ISO 535, Paper and board — Determination of water absorptiveness — Cobb method (ISO 535)
EN ISO 536, Paper and board — Determination of grammage (ISO 536)
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 9237, Textiles — Determination of permeability of fabrics to air (ISO 9237)
EN ISO 11607-1:2009+A1:2014, Packaging for terminally sterilized medical devices — Part 1:
Requirements for materials, sterile barrier systems and
...
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