BS EN 868-10:2009 - Packaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods

BS EN 868-10:2009

Packaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods

Status : Superseded, Withdrawn   Published : October 2009 Replaced By : BS EN 868-10:2018

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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. NOTE 1 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 nor modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. 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, may apply. The materials specified in this part of EN 868 are intended for single use only.




Standard NumberBS EN 868-10:2009
TitlePackaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
StatusSuperseded, Withdrawn
Publication Date31 October 2009
Withdrawn Date09 January 2019
Normative References(Required to achieve compliance to this standard)ISO 1924-2:1994, ISO 5636-3, ISO 536:1995, ISO 1974:1990, EN ISO 1924-2, EN ISO 536, EN 20811, ASTM D 2724:1987, ISO 6588-2, EN 21974, EN ISO 2758, ISO 11607-1:2006, ISO 8601, EN ISO 11607-1:2006, ISO 2758:2001
Informative References(Provided for Information)EN ISO 11607-2, EN 1041, EN ISO 11607-1, EN ISO 10993-1, ISO 11607-2:2006, EN 20811, ISO 10993-1:2003, 93/42/EEC, EN ISO 11607, EN 868-10:2000
Replaced ByBS EN 868-10:2018
ReplacesBS EN 868-10:2000
International RelationshipsEN 868-10:2009
Draft Superseded By07/30167336 DC
DescriptorsSterile equipment, Polyolefins, Packaging materials, Medical instruments, Strength of materials, Heat-sealing materials, Coatings, Packaging, Coated materials, Adhesives, Polyolefin fibres, Sterilization (hygiene), Medical equipment
ICS11.080.30
55.040
Title in FrenchMatériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal. Non tissés à base de polyoléfines, enduits d'adhésif, pour la fabrication de sachets, gaines et opercules thermoscellables. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte. Klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 59169 3
PublisherBSI
FormatA4
DeliveryYes
Pages16
File Size359 KB
Price£130.00


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