SIST EN 868-8:2009

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 per-formance 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.

Verpackungsmaterialien 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

Cette partie de l’EN 868 présente des méthodes d’essai et des valeurs pour des conteneurs réutilisables pour stérilisation à la vapeur d’eau.
Cette partie de l'EN 868 n'introduit pas d'exigences supplémentaires par rapport aux exigences générales spécifiées dans l'EN ISO 11607-1.
Les exigences particulières dans les paragraphes 4.2 à 4.5 peuvent être utilisées pour démontrer la conformité à une ou plusieurs, mais pas toutes les exigences de l’EN ISO 11607-1.
Les conteneurs spécifiés dans cette partie de la norme sont destinés à être utilisés en tant que système d’emballage durant la stérilisation de dispositifs médicaux dans des stérilisateurs à la vapeur conformes à l’EN 285 et le transport et le stockage consécutifs de ces dispositifs.
NOTE 1   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 2   Lorsque des articles doivent être emballés dans des enveloppes multiples pour satisfaire aux exigences générales, il convient de les emballer dans un premier temps dans un matériau d’emballage de stérilisation (par exemple, un matériau comme spécifié dans d’autres parties de cette série de normes).

Embalaža za končno sterilizirane medicinske pripomočke - 8. del: Ponovno uporabljivi vsebniki za parne sterilizatorje po EN 285 - Zahteve in preskusne metode

General Information

• Status: Withdrawn
• Publication Date: 09-Sep-2009
• Withdrawal Date: 03-Feb-2019
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Feb-2019
• Due Date: 24-Feb-2019
• Completion Date: 04-Feb-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 868-8:2009 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Relations

• Replaced By: SIST EN 868-8:2019 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• Effective Date: 01-Mar-2019
• Replaced By: SIST EN 868-8:2019 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 868-8:2000 - Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• Effective Date: 01-Oct-2009
• Replaces: SIST EN 868-8:2000 - Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 868-8:2009
01-oktober-2009
1DGRPHãþD
SIST EN 868-8:2000
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO3RQRYQR
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
Verpackungsmaterialien 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: EN 868-8:2009
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN 868-8:2009 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 868-8:2009

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SIST EN 868-8:2009
EUROPEAN STANDARD
EN 868-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.080.30 Supersedes EN 868-8:1999
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 sterilisierende
stérilisés au stade terminal - Partie 8: Conteneurs Medizinprodukte - Teil 8: Wiederverwendbare
réutilisables de stérilisation pour stérilisateurs à la vapeur Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285 -
d'eau conformes à l'EN 285 - Exigences et méthodes Anforderungen und Prüfverfahren
d'essai
This European Standard was approved by CEN on 23 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 868-8:2009: E
worldwide for CEN national Members.

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SIST EN 868-8:2009
EN 868-8:2009 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Requirements .5
5 Information to be supplied by the manufacturer .8
6 Test methods .9
Annex A (informative) Details of significant technical changes between this European Standard
and the previous edition . 10
Annex B (informative) Guidance on dimensions . 11
Annex C (normative) Handle strength test . 12
Annex D (normative) Stacking test . 13
Annex E (normative) Stacking device capability test . 14
Annex F (normative) Determination of sterilization performance . 15
Annex G (normative) Load dryness tests . 16
Annex H (informative) Guidance on determination of useful life . 18
Bibliography . 19

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SIST EN 868-8:2009
EN 868-8:2009 (E)
Foreword
This document (EN 868-8:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
medical purposes”, 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by November 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 868-8:1999.
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 for
medical purposes" 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 organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
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SIST EN 868-8:2009
EN 868-8:2009 (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.
Every sterile barrier system shall fulfil the requirements of 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.
During the revision of EN 868 parts 2 to 10 CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/2003
relating to the implementation of the uncertainty of measurement concept in standards. Following this
Resolution and the corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods
needed to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that the
information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their
next revisions.
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.
4

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SIST EN 868-8:2009
EN 868-8:2009 (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 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 per-
formance 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.
2 Normative references
The following referenced documents are indispensable for the application 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 285:2006, Sterilization — Steam sterilizers — Large sterilizers
EN 10088-1, Stainless steels — Part 1: List of stainless steels
EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999)
EN ISO 11607-1:2006, 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 11607-1:2006 and EN 285:2006
apply.
4 Requirements
4.1 General
The requirements of EN ISO 11607-1 apply.
NOTE 1 EN ISO 11607-1, 5.1.10 specifies additional requirements for reusable containers.
5

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SIST EN 868-8:2009
EN 868-8:2009 (E)
NOTE 2 EN ISO 11607-1:2006, 5.1.4 refers to conditions during production and handling with respect to their impact
on the product (e.g. electrostatic conductivity, bioburden if applicable).
NOTE 3 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2.
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. handles 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 informative Annex B.
4.2.1.3 For ease of cleaning all internal corners shall be radiused.
4.2.2 Lids and lid-latching devices
4.2.2.1 Access to the interior of the container shall be provided by a lid.
4.2.2.2 The lid shall be secured to the base during use by locking devices. The closure shall comply with
the requirements in EN ISO 11607-1:2006, 5.1.10 c).
4.2.3 Tamper evident closure system
4.2.3.1 A tamper evident closure system complying with EN ISO 11607-1:2006, 5.1.10 a) shall be
available.
4.2.3.2 If the 'tamper evident' closure system is not a single-use disposable item, i.e. does not irrevocably
break when opened, then a special tool, key, code or treatment shall be required to re-set the closure system.
4.2.4 Gasket
4.2.4.1 The interface between the lid and base shall be provided with a closure gasket. The closure
formed by the gasket with the lid latched in position shall provide microbial barrier properties as specified in
EN ISO 11607-1:2006, 5.2 and 5.1.10 c).
4.2.4.2 The gasket shall be accessible for cleaning. Frequency and method of maintenance shall be
specified by the manufacturer (see Clause 5).
4.2.5 Handles
4.2.5.1 Each container shall be provided with a suitable carrying device.
4.2.5.2 The carrying devices, the means of their attachment to the container, and the container itself shall
be sufficiently robust to support the weight of the filled container without permanent deformation > 1 mm when
tested in accordance with Annex C. If a permanent deformation is measured, performance characteristics of
the container (in particular sterile barrier properties) shall be demonstrated to remain unchanged.
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SIST EN 868-8:2009
EN 868-8:2009 (E)
4.2.6 Stacking capability
4.2.6.1 The top and base of each container shall be sufficiently strong to allow stacking and shall be fitted
with means to ensure that all containers of the same nominal
...