SIST EN 868-8:2019
(Main)Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.
NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users.
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 nor modify the general requirements specified in EN ISO 11607-1.
As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature.
NOTE 3 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.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 8: Wiederverwendbare Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285 - Anforderungen und Prüfverfahren
Dieses Dokument legt Prüfverfahren und Werte für wiederverwendbare Sterilisierbehälter fest, die dazu vorgesehen sind, als Sterilbarrieresysteme die Sterilität von in der Endverpackung sterilisierten Medizinpro¬dukten bis zum Anwendungszeitpunkt zu erhalten. Diese Sterilisierbehälter sind für Dampf-Sterilisatoren nach EN 285 vorgesehen.
ANMERKUNG 1 Das Erfordernis für eine zusätzliche Innenverpackung kann durch den Hersteller und den Anwender bestimmt werden.
Im Gegensatz zu den allgemeinen Anforderungen, welche durch EN ISO 11607 1 und EN ISO 11607 2 festge¬legt sind, legt dieser Teil der EN 868 Materialien, Prüfverfahren und Werte fest, welche spezifisch für die in diesem Dokument betrachteten Produkte sind.
ANMERKUNG 2 Wenn der Sterilisierbehälter in einem Dampf Sterilisator verwendet werden soll, der nicht EN 285 entspricht, so wird das Sterilisierverhalten des Sterilisierbehälters für den anzuwendenden spezifischen Sterilisa¬tionszyklus durch den Anwender validiert. Andere Merkmale des Sterilisierbehälters werden hinsichtlich der Kompa¬tibilität mit dem Sterilisationszyklus erneut überprüft, z. B. die Arbeitstemperatur.
ANMERKUNG 3 Die Verwendung von zusätzlichen Materialien und/oder von Zubehör innerhalb des Sterilbarrieresystems, um die Organisation, die Trocknung oder die aseptische Präsentation zu erleichtern (z. B. Innenver¬packung, Indikatoren, Verpackungslisten, Unterlagen, Einsätze für Instrumente, Fächer oder eine zusätzliche Umhüllung für das Medizinprodukt) ist nicht in diesem Teil der EN 868 abgedeckt. Dennoch können andere Anforderungen, einschließlich der Bestimmung der Eignung dieser Materialien und/oder Zubehör im Rahmen von Validierungsstudien gelten.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 8: Conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d’eau conformes à l’EN 285 - Exigences et méthodes d’essai
Le présent document spécifie des méthodes d’essai et des valeurs relatives aux conteneurs réutilisables employés comme systèmes de barrière stérile destinés à maintenir l’état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu’au point d’utilisation. Ces conteneurs sont destinés à être utilisés dans les stérilisateurs à la vapeur d’eau, conformément à l’EN 285.
NOTE 1 La nécessité d’un matériau d’emballage à l’intérieur du conteneur est déterminée par les fabricants et les utilisateurs.
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 le présent document.
NOTE 2 Lorsqu’il est prévu d’utiliser les conteneurs dans un stérilisateur à la vapeur non conforme à l’EN 285, les performances de stérilisation du conteneur dans le cycle de stérilisation spécifique à utiliser sont validées par l’utilisateur. D’autres caractéristiques du conteneur sont également examinées pour contrôler la compatibilité avec le cycle du stérilisateur, par exemple, la température de consigne.
NOTE 3 L’utilisation d’accessoires et/ou de matériaux supplémentaires à l’intérieur du système de barrière stérile de manière à faciliter le rangement, le séchage ou la présentation aseptique (par exemple, enveloppe interne, indicateurs, listes d’emballage, tapis, dispositifs de rangement des instruments, fonds de paniers ou une enveloppe supplémentaire entourant le dispositif médical), n’est pas couverte par la présente partie de l’EN 868. Toutefois, d’autres exigences, notamment concernant la détermination de l’acceptabilité de ces matériaux et/ou accessoires pendant les activités de validation, peuvent s’appliquer.
Embalaža za končno sterilizirane medicinske pripomočke - 8. del: Ponovno uporabljivi vsebniki za parne sterilizatorje po EN 285 - Zahteve in preskusne metode
Ta del standarda EN 868 podaja preskusne metode in vrednosti za vrečke in zvitke iz poroznega materiala z možnostjo tesnjenja, izdelane v skladu s standardom EN 868, deli 2, 3, 6, 7, 9 ali 10, in plastične folije v skladu s točko 4, ki se uporabljajo kot sterilni pregradni sistemi in/ali sistemi embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
OPOMBA 1: Potrebo po zaščitni embalaži lahko določita proizvajalec in uporabnik. Ta del standarda EN 868 le uvaja zahteve delovanja in preskusne metode, ki veljajo 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 točk od 4.2 do 4.5 je mogoče uporabiti za dokazovanje skladnosti z eno ali več zahtevami, vendar ne z vsemi zahtevami standarda EN ISO 11607-1.
Materiali, določeni v tem delu standarda ISO 868, so namenjeni le enkratni uporabi.
OPOMBA 2: Ko se znotraj sterilnega pregradnega sistema uporabljajo dodatni materiali za lažjo organizacijo, sušenje ali aseptičnost (npr. notranji ovoj, kazalniki filtrov, 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.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 868-8:2019
01-marec-2019
1DGRPHãþD
SIST EN 868-8:2009
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO 3RQRYQR
XSRUDEOMLYLYVHEQLNL]DSDUQHVWHULOL]DWRUMHSR(1=DKWHYHLQSUHVNXVQH
PHWRGH
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization
containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 8:
Wiederverwendbare Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285 -
Anforderungen und Prüfverfahren
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 8: Conteneurs
réutilisables de stérilisation pour stérilisateurs à la vapeur d’eau conformes à l’EN 285 -
Exigences et méthodes d’essai
Ta slovenski standard je istoveten z: EN 868-8:2018
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN 868-8:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 868-8:2019
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SIST EN 868-8:2019
EN 868-8
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN 868-8:2009
English Version
Packaging for terminally sterilized medical devices - Part
8: Re-usable sterilization containers for steam sterilizers
conforming to EN 285 - Requirements and test methods
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 8: Conteneurs réutilisables de sterilisierende Medizinprodukte - Teil 8:
stérilisation pour stérilisateurs à la vapeur d'eau Wiederverwendbare Sterilisierbehälter für Dampf-
conformes à l'EN 285 - Exigences et méthodes d'essai Sterilisatoren nach EN 285 - Anforderungen und
Prüfverfahren
This European Standard was approved by CEN on 20 August 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 868-8:2018 E
worldwide for CEN national Members.
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SIST EN 868-8:2019
EN 868-8:2018 (E)
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Requirements . 8
5 Information to be supplied by the manufacturer . 11
Annex A (informative) Details of significant technical changes between this document and
the previous edition . 12
Annex B (informative) Guidance on dimensions . 13
Annex C (normative) Carrying device strength test . 14
C.1 Procedure. 14
C.2 Result . 14
Annex D (normative) Stacking test - Procedure . 15
Annex E (normative) Stacking device capability test . 16
E.1 Apparatus . 16
E.2 Procedure. 16
Annex F (normative) Determination of sterilization performance . 17
F.1 Apparatus . 17
F.2 Procedure. 17
F.3 Results . 17
Annex G (normative) Load dryness tests . 18
G.1 Apparatus . 18
G.2 Loads . 18
G.2.1 Metal . 18
G.2.2 Textile . 18
G.3 Procedure. 18
G.3.1 Metal Load. 18
G.3.2 Textile load . 18
G.4 Results . 19
G.4.1 Metal load . 19
G.4.2 Textile load . 19
2
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EN 868-8:2018 (E)
Annex H (informative) Guidance on determination of service life with respect to
sterilization . 20
H.1 Test specimen . 20
H.2 Apparatus . 20
Bibliography . 21
3
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SIST EN 868-8:2019
EN 868-8:2018 (E)
European foreword
This document (EN 868-8:2018) 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 886-8:2009.
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,
4
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SIST EN 868-8:2019
EN 868-8:2018 (E)
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
5
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SIST EN 868-8:2019
EN 868-8:2018 (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.
6
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SIST EN 868-8:2019
EN 868-8:2018 (E)
1 Scope
This document specifies test methods and values for re-usable containers used as sterile barrier
systems that are intended to maintain sterility of terminally sterilized medical devices to the point of
use. These containers are intended to be used in steam sterilizers conforming to EN 285.
NOTE 1 The need for a packaging material inside the container is determined by the manufacturers and users.
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.
NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the
sterilization performance of the container in the specific sterilization cycle to be used is validated by the user.
Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g. operating
temperature.
NOTE 3 The use of additional materials and/or accessories 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) is not covered in this part of EN 868.
However, other requirements, including the determination of the acceptability of these materials and/or
accessories during validation activities, can apply.
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 285:2015, Sterilization — Steam sterilizers — Large sterilizers
EN 10088-1, Stainless steels — Part 1: List of stainless steels
EN ISO 4017:2014, Fasteners — Hexagon head screws — Product grades A and B (ISO 4017:2014)
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 4582, Plastics — Determination of changes in colour and variations in properties after exposure to
glass-filtered solar radiation, natural weathering or laboratory radiation sources
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2017 and
EN 285:2015 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
7
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SIST EN 868-8:2019
EN 868-8:2018 (E)
4 Requirements
4.1 General
For any 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 particular requirements in 4.2, 4.3 and 4.4 can be used to demonstrate compliance with one
or more but not all of the requirements of EN ISO 11607-1.
NOTE 1 Compliance to EN 868-8 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-8 shall contain a statement whether EN ISO 11607-1 is
covered.
4.2 Requirements for construction and design
4.2.1 Shape and dimension
4.2.1.1 The container shall be in the general form of a parallelepipedal box.
NOTE Slight curvature or camber of the flat surfaces can be acceptable. Rounding of the corners is desirable.
4.2.1.2 The container including all connected parts, e.g. carrying devices shall fit within one
sterilization module (see EN 285).
NOTE 1 If the container does not fit within one sterilization module, but complies with all other requirements
of this part of the standard, the manufacturer can claim compliance with EN ISO 11607-1, but not with EN 868-8.
NOTE
...
SLOVENSKI STANDARD
oSIST prEN 868-8:2017
01-oktober-2017
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO 3RQRYQR
XSRUDEOMLYLYVHEQLNL]DSDUQHVWHULOL]DWRUMHSR(1=DKWHYHLQSUHVNXVQH
PHWRGH
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization
containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 8:
Wiederverwendbare Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285 -
Anforderungen und Prüfverfahren
Matériaux et systèmes d’emballage pour les dispositifs médicaux stérilisés au stade
terminal - Partie 8 : Conteneurs réutilisables de stérilisation pour stérilisateurs à la
vapeur d’eau conformes à l’EN 285 - Exigences et méthodes d’essai
Ta slovenski standard je istoveten z: prEN 868-8
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN 868-8:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 868-8:2017
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oSIST prEN 868-8:2017
DRAFT
EUROPEAN STANDARD
prEN 868-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2017
ICS 11.080.30 Will supersede EN 868-8:2009
English Version
Packaging for terminally sterilized medical devices - Part
8: Re-usable sterilization containers for steam sterilizers
conforming to EN 285 - Requirements and test methods
Matériaux d'emballage pour les dispositifs médicaux - Verpackungen für in der Endverpackung zu
Partie 8 : Conteneurs réutilisables de stérilisation pour sterilisierende Medizinprodukte - Teil 8:
stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Wiederverwendbare Sterilisierbehälter für Dampf-
Exigences et méthodes d'essai Sterilisatoren nach EN 285 - 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, 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.
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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 868-8:2017 E
worldwide for CEN national Members.
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oSIST prEN 868-8:2017
prEN 868-8:2017 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 7
4.1 General . 7
4.2 Requirements for construction and design . 7
4.3 Service life . 9
4.4 Material requirements . 9
4.5 Marking . 10
5 Information to be supplied by the manufacturer . 10
Annex A (informative) Details of significant technical changes between this European
Standard and the previous edition . 11
Annex B (informative) Guidance on dimensions . 12
Annex C (normative) Carrying device strength test . 13
C.1 Procedure. 13
C.2 Result . 13
Annex D (normative) Stacking test - Procedure . 14
Annex E (normative) Stacking device capability test . 15
E.1 Apparatus . 15
E.2 Procedure. 15
Annex F (normative) Determination of sterilization performance . 16
F.1 Apparatus . 16
F.2 Procedure. 16
F.3 Results . 16
Annex G (normative) Load dryness tests . 17
G.1 Apparatus . 17
G.2 Loads . 17
G.3 Procedure. 17
G.4 Results . 18
Annex H (informative) Guidance on determination of useful life with respect to
sterilization . 19
H.1 Test specimen . 19
2
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oSIST prEN 868-8:2017
prEN 868-8:2017 (E)
H.2 Apparatus . 19
Bibliography . 20
3
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oSIST prEN 868-8:2017
prEN 868-8:2017 (E)
European foreword
This document (prEN 868-8:2017) 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 document is currently submitted to the CEN Enquiry.
This document will supersede EN 886-8:2009.
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).
4
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oSIST prEN 868-8:2017
prEN 868-8:2017 (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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oSIST prEN 868-8:2017
prEN 868-8:2017 (E)
1 Scope
This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier
systems that are intended to maintain sterility of terminally sterilized medical devices to the point of
use. These containers are intended to be used in steam sterilizers conforming to EN 285.
NOTE 1 The need for a packaging material inside the container is determined by the manufacturers and users.
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.
NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the
sterilization performance of the container in the specific sterilization cycle to be used is validated by the user.
Other attributes of the container are also reviewed for compatibility with the sterilizer cycle, e.g. operating
temperature.
NOTE 3 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.
Secretary remark (to be deleted by formal vote stage): CEN/TC 102/WG 4 proposes to change the Scope of
the work item in order to align the scope with the recently published new editions of EN 868-2, −3, 4- −6
and −7. Please consider that a positive ballot on prEN 858-8 during enquiry includes the approval of the
revised scope.
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 285:2015, Sterilization - Steam sterilizers - Large sterilizers
EN 10088-1, Stainless steels - Part 1: List of stainless steels
EN ISO 4017:2014, Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices - Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
ISO 4582, Plastics — Determination of changes in colour and variations in properties after exposure to
daylight under glass, natural weathering or laboratory light sources
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009 and
EN 285:2015 apply.
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oSIST prEN 868-8:2017
prEN 868-8:2017 (E)
4 Requirements
4.1 General
For any preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1
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 particular requirements in 4.2, 4.3 and 4.4 can be used to demonstrate compliance with one
or more but not all of the requirements of EN ISO 11607-1.
NOTE 1 Compliance to EN 868–8 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-8 shall contain a statement whether EN ISO 11607-1 is
covered.
NOTE 2 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, can apply.
4.2 Requirements for construction and design
4.2.1 Shape and dimension
4.2.1.1 The container shall be in the general form of a parallelepipedal box.
NOTE Slight curvature or camber of the flat surfaces can be acceptable. Rounding of the corners is desirable.
4.2.1.2 The container including all connected parts, e.g. carrying devices shall fit within one
sterilization module (see EN 285).
NOTE 1 If the container does not fit within one sterilization module, but complies with all other requirements
of this part of the standard, the manufacturer can claim compliance with EN ISO 11607-1, but not with EN 868–8.
NOTE 2 For guidance on dimensions see in
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