BS EN 868-6:2017 - Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods

BS EN 868-6:2017

Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods

Status : Current   Published : February 2017

Format
PDF

Format
HARDCOPY



This draft European Standard provides test methods and values for paper used in the manufacture of preformed 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 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs. NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only. 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 filters, 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 868-6:2017
TitlePackaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
StatusCurrent
Publication Date28 February 2017
Normative References(Required to achieve compliance to this standard)ISO 187, ISO 5636-3, ISO 535, ISO 2758, ISO 8601, EN 20187, ISO 2470-2, EN ISO 535, ISO 9198, EN ISO 536, ISO 536, ISO 9197, EN ISO 1924-2, EN ISO 11607-1:2009+A1:2014, ISO 1924-2, EN ISO 2758, ISO 3689, ISO 11607-1:2006+AMD1:2014, ISO 3781, ISO 6588-2:2012, EN ISO 1974, ISO 1974
Informative References(Provided for Information)ISO 11607-2, EN ISO 11607-2, 93/42/EEC, EN 1041, ISO 5725-2
ReplacesBS EN 868-6:2009
International RelationshipsEN 868-6:2017
Draft Superseded By15/30325858 DC
DescriptorsMarking, Packages, Radiation, Fluorescence, Packaging materials, Visual inspection (testing), Water-resistance tests, Strength of materials, Waterproof materials, Purity, Medical equipment, Chemical composition, Packaging, Lids, Wrapping, Paper, Medical instruments, Tensile strength, Sterile equipment, Ethylene oxide, Sterilization (hygiene), Performance, Porosity measurement
ICS11.080.30
55.040
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Papier pour des procédés de stérilisation à basse température. Exigences et méthodes d'essai
Title in GermanVerpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte. Papier für Niedertemperatur-Sterilisationsverfahren. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 90657 2
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size497 KB
Price£182.00


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