BS EN 868-8:2009 - Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

BS EN 868-8:2009

Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods

Status : Superseded, Withdrawn   Published : October 2009 Replaced By : BS EN 868-8:2018

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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.




Standard NumberBS EN 868-8:2009
TitlePackaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
StatusSuperseded, Withdrawn
Publication Date31 October 2009
Withdrawn Date09 January 2019
Normative References(Required to achieve compliance to this standard)EN ISO 11607-2, ISO 4017:1999, ISO 11607-2:2006, 93/42/EEC, EN ISO 4017, EN 10088-1, EN ISO 11607-1:2006, ISO 11607-1:2006, EN 1041, ISO 4582, EN 285:2006
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN 868-8:2018
ReplacesBS EN 868-8:1999
International RelationshipsEN 868-8:2009
Draft Superseded By07/30167330 DC
DescriptorsPerformance, Sterilization (hygiene), Design, Marking, Ageing tests, Consumer-supplier relations, Closures, Handles, Life (durability), Packaging, Medical equipment, Weight measurement, Strength of materials, Visual inspection (testing), Instructions for use, Stacking tests, Holes, Packaging materials, Sterile equipment, Steam, Medical instruments, Packages, Mechanical testing, Re-usable packages, Performance testing, Load capacity, Dimensions, Containers, Lids
ICS11.080.30
55.120
Title in FrenchMatériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal. Conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte. Wiederverwendbare Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 59167 9
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size426 KB
Price£130.00


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