BS EN 868-5:2018 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods

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BS EN 868-5:2018

Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods

Status : Current   Published : January 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 of this document. These sealable pouches and reels are 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.

Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

The materials specified in this part of EN 868 are intended for single use only.

For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607‑1 shall apply.

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.




Standard NumberBS EN 868-5:2018
TitlePackaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
StatusCurrent
Publication Date07 January 2019
Cross ReferencesEN 868-7:2017, EN 868-2:2017, ISO 11607-1:2006/AMD 1:2014, EN 868-3:2017, EN 868-9:2018, ASTM D882 - 12, ASTM F88/F88M - 15, EN ISO 11140-1, ISO 8601, EN ISO 11607-1:2017, ISO 11140-1, EN 868-10:2018, ISO 11607-1:2006, EN 868-6:2017, EN ISO 14937, EN 1422, EN ISO 11607-2, EN 1041, ISO 14937, EN 14180, EN 285, ISO 11607-2, EN 13060, EN ISO 15223-1:2016, ISO 15223-1:2016
ReplacesBS EN 868-5:2009
International RelationshipsEN 868-5:2018
Draft Superseded By17/30360908 DC
DescriptorsPaper, Heat-sealing, Composite materials, Performance, Medical instruments, Sterile equipment, Marking, Performance testing, Visual inspection (testing), Packaging materials, Plastic films, Holes, Mechanical testing, Containers, Plastics, Peeling tests, Paper products, Stain tests, Fibres, Packaging, Drums (materials handling equipment), Medical equipment, Joints, Strength of materials, Sterilization (hygiene)
ICS11.080.30
55.040
55.080
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Sachets et gaines scellables constitués d'une face matière poreuse et d'une face film plastique. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Siegelfähige Klarsichtbeutel und -schläuche aus porösen Materialien und Kunststoff-Verbundfolie. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 98598 0
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size406 KB
Price£126.00


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