BS EN 868-4:2017 - Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods

BS EN 868-4:2017

Packaging for terminally sterilized medical devices. Paper bags. 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 bags manufactured from paper specified in EN 868-3, 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 to 4.6 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. 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 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 868-4:2017
TitlePackaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
StatusCurrent
Publication Date28 February 2017
Normative References(Required to achieve compliance to this standard)ISO 9198, ISO 11140-1, ISO 11607-1:2006/A1:2014, EN ISO 11607-2, ISO 9197, ISO 11607-1:2006, ISO 1924-2, EN ISO 1924-2, ISO 11607-2, EN 868-3, EN ISO 11140-1, EN ISO 11607-1:2009+A1:2014, ISO 6588-2:2012, ISO 8601
Informative References(Provided for Information)ISO 15223-1, 93/42/EEC, EN ISO 15223-1, EN 1041, ISO 5725-2
ReplacesBS EN 868-4:2009
International RelationshipsEN 868-4:2017
Draft Superseded By15/30325861 DC
DescriptorsBags, Chlorides, Marking, Packaging, Seals, Determination of content, Heat-sealing, Medical instruments, Wrapping, Sterile equipment, Sulfates, Design, Performance, Chemical analysis and testing, Paper products, Instructions for use, Signal devices, Medical equipment, pH measurement, Tensile strength, Sterilization (hygiene), Performance testing, Packaging materials, Strips
ICS11.080.30
55.040
55.080
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Sacs en papier. Exigences et méthodes d'essai
Title in GermanVerpackungsmaterialien für in der Endverpackung zu sterilisierende Medizinprodukte. Papierbeutel. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 90658 9
PublisherBSI
FormatA4
DeliveryYes
Pages18
File Size419 KB
Price£130.00


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