BS EN 868-3:2017 - Packaging for terminally sterilized medical devices. 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

BS EN 868-3:2017

Packaging for terminally sterilized medical devices. 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

Status : Current   Published : February 2017

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PDF

Format
HARDCOPY



This draft European Standard provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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 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 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. NOTE Applicable sterilization methods are specified by the manufacturer.




Standard NumberBS EN 868-3:2017
TitlePackaging for terminally sterilized medical devices. 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
StatusCurrent
Publication Date28 February 2017
Normative References(Required to achieve compliance to this standard)ISO 1974, ISO 5636-3, ISO 2758, ISO 535, ISO 11607-1:2006, ISO 6588-2:2012, ISO 1924-2, ISO 8601, ISO 536, ISO 3689, EN ISO 11607-1:2009+A1:2014, EN 20187, ISO 3781, EN ISO 536, EN ISO 2758, EN ISO 535, ISO 11607-1:2006/A1:2014, ISO 2470-2, EN ISO 1974, ISO 9198, ISO 9197, EN ISO 1924-2, ISO 187
Informative References(Provided for Information)ISO 11607-2, EN 1041, EN ISO 11607-2, 93/42/EEC, ISO 5725-2
ReplacesBS EN 868-3:2009
International RelationshipsEN 868-3:2017
Draft Superseded By15/30325867 DC
DescriptorsPorosity measurement, Performance testing, Marking, Fluorescence, Medical instruments, Tensile strength, Air permeability, Tear strength, Drums (materials handling equipment), Paper bags, Paper, Medical equipment, Optical properties of materials, Packaging, Performance, Packaging materials, Determination of content, pH, Water-resistance tests, Sterilization (hygiene), Weight tolerances, Containers, Sterile equipment, Porosity, Paper products
ICS11.080.30
55.040
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Papier utilisé dans la fabrication des sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5). Exigences et méthodes d'essai
Title in GermanVerpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte. Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5). Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 90660 2
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size589 KB
Price£182.00


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