BS EN 868-7:2017 - Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods

BS EN 868-7:2017

Packaging for terminally sterilized medical devices. Adhesive coated 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 sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. 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. 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 868-7:2017
TitlePackaging for terminally sterilized medical devices. Adhesive coated 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 535, ISO 1974, ISO 2758, ISO 5636-3, ISO 187, EN ISO 536, EN ISO 1974, ISO 8601, EN 20187, ISO 1924-2, ISO 3781, ISO 536, EN ISO 535, ISO 3689, ISO 2470-2, EN ISO 11607-1:2009+A1:2014, ISO 11607-1:2006+AMD1:2014, ISO 9198, EN ISO 1924-2, EN ISO 2758, ISO 9197, ISO 6588-2:2012
Informative References(Provided for Information)EN ISO 11607-2, EN 1041, ISO 11607-2, 93/42/EEC, ISO 5725-2
ReplacesBS EN 868-7:2009
International RelationshipsEN 868-7:2017
Draft Superseded By15/30325864 DC
DescriptorsHeat-sealing, Visual inspection (testing), Adhesive paper, Strength of materials, Ethylene oxide, Paper, Weight measurement, Water-resistance tests, Packaging materials, Medical instruments, Sterile equipment, Packaging, Medical equipment, Mass, Marking, Coatings, Adhesives, Porosity measurement, Fluorescence, Waterproof materials, Packages, Tensile strength, Performance, Determination of content, Chemical analysis and testing, Sterilization (hygiene), pH, Radiation, Adhesion tests, Low temperatures, Instructions for use, Wrapping
ICS11.080.30
55.040
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Papier enduit d'adhésif pour des procédés de stérilisation à basse température. Exigences et méthodes d'essai
Title in GermanVerpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte. Klebemittelbeschichtetes Papier für Niedertemperatur-Sterilisationsverfahren. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 90659 6
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size521 KB
Price£182.00


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